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Tales From the Clinic: The Art of Psychiatry

, we examine the case of alcohol use disorder with difficult relapses. AUDs are known to be 1 of the most prevalent mental health disorders worldwide. This discussion examines comorbidities and barriers to treatment.

“Ms Frank” is a young woman with a history of 

 (PTSD), and bipolar disorder who is currently receiving psychiatric care at an outpatient program. She has a severe trauma history that has never been fully discussed with a therapist or psychiatrist, despite years of treatment. She has chronic suicidal thoughts after multiple previous attempts by overdose. 

 is increased in times of intoxication, and suicidal thoughts have never completely gone away even with the switch to lithium. She has failed over 15 medications and is often sensitive to adverse effects.

After a significant suicide attempt and inpatient rehabilitation for 90 days, Ms Frank achieved and maintained sobriety for almost 2 years prior to being put into a supervisory role at her sober living facility. Some of her duties in this included expelling people who had relapsed, including people she had gotten to know as friends. She felt that “everyone relapses anyway” and “there’s no point,” and subsequently relapsed herself with successive suicide attempts and psychiatric hospitalizations. She has since regained sobriety and gone to another 30-day 

. She continues to struggle with persistent suicidal thoughts and difficulty engaging with therapy; however, she has managed to again achieve and maintain sobriety for over a month with a medication regimen including naltrexone monthly injectable, which has reportedly helped with her cravings. She has previously tried and failed naltrexone by mouth, acamprosate, and disulfiram due to 

. She regularly attends Alcoholics Anonymous meetings and therapy.

Ms Frank’s history is significant for a pervasive pattern of instability in personal relationships; impulsivity; affective instability; difficulty controlling anger; and recurrent suicidal behavior, gestures, and threats concerning for an underlying cluster B personality disorder. While she deals with these issues, she does maintain a close circle of friends and is able to maintain a consistent job.

AUDs are known to be 1 of the most prevalent mental health disorders worldwide. As seen in 

, according to the 2019 National Survey on Drug Use and Health (NSDUH), 7.6% of men and 4.1% of women aged 18 and older suffer from AUD.

 As the prevalence of AUDs has continued to rise, various methods of detection have been recommended. The Alcohol Use Disorder Identification Test (AUDIT) is recommended by the World Health Organization as a screening tool to detect alcohol problems. Different AUDIT scoring thresholds are required for men and women, as research has shown that AUDs in women have distinctive social and biological characteristics.

, women develop a higher blood alcohol concentration than men. Therefore, the Centers for Disease Control and Prevention (CDC) provides distinctive cutoffs for alcohol use and binge drinking in women vs men, as seen in 

. Women are also more susceptible to the toxic effects of alcohol such as cognitive disorders, 

, and liver cirrhosis. Women also differ in their approach to the health care system, which may influence their performance on self-reported screening tests.

 Women also often display a shorter trajectory from onset of alcohol use to the diagnosis of AUD. The prevalence of AUD in women has steadily increased in women, resulting in a narrower gender gap in AUD diagnoses.

 These are a few of the many reasons it is imperative to utilize a lower screening threshold when assessing female patients for AUDs.

Despite the increasing prevalence of AUDs and the multitude of services available, national surveys consistently demonstrate low utilization of treatments, as seen in 

 Gender disparities in the utilization of treatment are long-standing and significant. Women have about one-third to one-half the odds of utilizing any alcohol use treatment when compared to men.

 and beliefs that treatment is ineffective seem to play a large role across the board. In a recent study, women were found to be more likely than men to report attitudinal barriers to treatment. These barriers consisted of shame, fear of others finding out, belief that no one can help, and the belief that the problem is not serious enough.

 Several gender-specific factors have been identified as reasons women are less likely to seek help, further warranting the need for tailored interventions.

Although underutilized, effective and safe treatment for AUD is available through psychosocial and pharmacological interventions.

 The combination of pharmacotherapy and psychotherapy (

, individual and group drug counseling, motivational enhancement therapy, etc) has been found to enhance outcomes for AUD. Currently, the Federal Drug Administration (FDA)-approved drugs for AUD include disulfiram, acamprosate, and naltrexone. Disulfiram, commonly known as Antabuse, acts by blocking the metabolism of alcohol leading to an accumulation of acetaldehyde, a toxic substance that results in tachycardia, 

, nausea, and vomiting after an individual consumes alcohol. Acamprosate has been associated with decreased craving and consumption of alcohol through agonist activity at GABA receptors and inhibitory activity at NMDA receptors. Naltrexone, available in oral formulation as well as long-acting injectable form, has been shown to decrease cravings and help prevent relapse through its action as an opioid antagonist.

Advances in addiction neurobiology have led to the development of the FDA-approved medications previously mentioned; however, 

 retail medication sales remain relatively small when considering the size of the population that could benefit. According to the 2019 NSDUH, only about 7.3% of adults aged 18 and older with AUD received any treatment in the past year. As seen in 

, less than 4% of patients with AUD were prescribed an FDA-approved medication for AUD.

Individuals struggling with AUD are unlikely to initially seek help from specialty providers. The best chance of identifying AUD usually occurs within the primary care setting; however, the recognition of AUD remains low in such settings.

 Studies have identified reasons such as limited time, limited organizational capacity, fear of losing patients, and feelings of incompetency regarding treatment of AUD as 

 regarding identification of AUD in primary care.

 Within primary care settings, there is evidence to support the effectiveness of AUD screening, brief interventions, and referral to specialized treatment (SBIRT). However, the implementation of models for identifying and treating AUD in primary care remain inadequate.

 Effective treatment may be more widely utilized if measures are taken to increase primary care participation, destigmatize AUD, and address inaccurate attitudes about treatment efficacy.

Not only are AUDs associated with many physical illnesses, but they also often cooccur with other mental health disorders. Significant associations exist with other substance use disorders, major depressive disorder, generalized anxiety disorder, panic disorder, PTSD, 

, specific phobias, and antisocial and borderline personality disorders. 

 in patients with AUD tend to lead to increased risk of suicide, lower rates of treatment retention, shorter period before relapse, greater number of hospital admissions, and overall poorer clinical course.

When formulating treatment plans for patients with cooccurring disorders, it is imperative to determine the chronology of onset of the diseases. The clinical course tends to be determined by the primary diagnosis. Comorbidity has particularly important clinical implications in cases where psychiatric symptoms increase the 

. AUD in patients with depressive disorder is associated with increased suicidality.

 Personality traits that are often associated with increased risk for alcohol abuse, impulsivity, negative emotionality, and antagonism are also characteristics of 

(BPD) and antisocial personality disorder.

Although these disorders are highly comorbid and result in poorer prognosis when they occur together, there are limited treatments that target the symptoms of both BPD and AUD. There is promising evidence that some anticonvulsants (topiramate, lamotrigine)and second-generation 

 (aripiprazole, olanzapine) may reduce the anger, impulsivity, and mood lability present in BPD. There are also studies suggesting that these same medications may also reduce alcohol craving and consumption.

 It should be noted that these medications are not FDA approved for BPD or AUD. Modified psychotherapies have been developed for the treatment of comorbid AUD and BPD (dynamic deconstructive therapy, dialectical behavior therapy, and dual focus schema therapy); however, there is limited evidence to support the efficacy of these modalities on treating symptoms of both disorders concurrently. Only dynamic deconstructive psychotherapy has been specifically tested on patients with both AUD and BPD. Evidence shows that although this therapy may be successful in treating symptoms of BPD, its efficacy in reducing alcohol consumption may not be sustained long-term.

The efficacy of the other 2 models in the treatment of AUD has not yet been established.

 Due to the lack of sufficient evidence, psychotherapies for antisocial personality disorder (ASPD) are limited.

 Although there is sparse evidence to support pharmacotherapy for ASPD, medications can be used to treat symptoms of the disease, such as aggression and impulsivity.

Alcohol use disorders are known to be one of the most prevalent mental health disorders in the world. In order to effectively treat these disorders, an awareness and utilization of evidence based treatment options is imperative. Furthermore, barriers to seeking care in this particular population require special consideration when formulating treatment plans.

is a PGY 3 general psychiatry resident at Menninger Department of Psychiatry & Behavioral Sciences at the Baylor College of Medicine. She plans to pursue a fellowship in forensic psychiatry after graduation. 

is a psychiatry resident at Baylor College of Medicine. 

is an addiction psychiatrist at Baylor College of Medicine and the Director of the Consult Liaison Psychiatry service at the Ben Taub General Hospital- Harris Health System- Houston, Texas.

1. Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality. 2019 NationalSurvey on Drug Use and Health. Table 5.4B – Alcohol Use Disorder in Past Year amongPersons Aged 12 or Older, by Age Group and Demographic Characteristics: Percentages,2018 and 2019. Accessed January 5, 2022. 

https://www.samhsa.gov/data/sites/default/files/reports/rpt29394/NSDUHDetailedTabs2019/NSDUHDetTabsSect5pe2019.htm

2. Neumann T, Neuner B, Gentilello LM, et al. 

Gender differences in the performance of a computerized version of the alcohol use disorders identification test in subcritically injured patients who are admitted to the emergency department.

3. McHugh RK, Votaw VR, Sugarman DE, Greenfield SF. 

Sex and gender differences in substance use disorder.

4. Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality. 2019 NationalSurvey on Drug Use and Health. Table 5.11B – Received Alcohol Use Treatment in PastYear among Persons Aged 12 or Older, by Age Group and Demographic Characteristics:Percentages, 2018 and 2019. Accessed January 5, 2022. 

Gender differences in use of alcohol treatment services and reasons for nonuse in a national sample.

Influence of gender and race/ethnicity on perceived barriers to help-seeking for alcohol or drug problems.

Advances in the science and treatment of alcohol use disorder.

8. National Institute on Alcohol Abuse and Alcoholism. Alcohol facts and statistics. Updated June 2021. Accessed January 5, 2022. 

https://www.niaaa.nih.gov/publications/brochures-and-fact-sheets/alcohol-facts-and-statistics

9. Rombouts SA, Conigrave J, Louie E, et al. 

Evidence-based models of care forthe treatment of alcohol use disorder in primary health care settings: protocol for systematic review.

10. Storholm ED, Ober AJ, Hunter SB, et al. 

Barriers to integrating the continuum of care for opioid and alcohol use disorders in primary care: a qualitative longitudinal study.

Dual diagnosis: alcoholism and co-morbid psychiatric disorders.

12. Helle AC, Watts AL, Trull TJ, Sher KJ. 

Alcohol use disorder and antisocial and borderline personality disorders.

13. Gianoli MO, Jane JS, O'Brien E, Ralevski E. 

Treatment for comorbid borderline personality disorder and alcohol use disorders: a review of the evidence and future recommendations.

14. Khalifa N, Duggan C, Stoffers J, et al. 

Pharmacological interventions for antisocial personality disorder.

15. Centers for Disease Control and Prevention. Alcohol Use Basics. Updated December 30, 2019. Accessed January 5, 2022. 

https://www.cdc.gov/alcohol/fact-sheets.htm

Approximately 7.6% of men and 4.1% of women aged 18 and older suffer from AUD, but national surveys consistently demonstrate low utilization of treatments. 

Everyone Relapses Anyway. Or Do They?

A version of this quiz originally appeared in our sister publication, 

Test your knowledge of holiday drinking habits.

10 Questions on Holiday Spirits

, about her innovate approach to drug use among teenagers. Avoiding old-fashioned scare tactics, Martinez talks to students and their parents about the neurological effects of substances like cannabis and alcohol. Could scientific education be a key protective factor against addiction?

The rising rate of teen cannabis use and its potential causes.

The effects of smoking marijuana on brain development.

How other psychiatric illnesses can lead to substance abuse disorders.

How to talk to teenagers about substance use—without being overbearing.

Distinguishing between experimental and problematic substance use.

is a child and adolescent psychiatry fellow at New York-Presbyterian Hospital.

Thanks to Columbia University Department of Psychiatry for allowing us to present the Caring for Teens and Tweens podcast with experts in the field of psychiatry.

Scare tactics don’t work. But scientific education might. Here are tips for talking with teenaged patients about keeping themselves and their friends safe. 

How to Talk to Teenagers About Substance Use

 Tales of the Clinic: The Art of Psychiatry

, we discuss a patient who was construed as difficult to manage by multiple standards and elicited strong feelings from the treatment team. Ms Grant is a 29-year-old female with a history of alcohol use disorder (AUD) and complicated alcohol withdrawal. This case presentation spans 4 years and highlights the importance of behavior shaping and personality trait management to achieve stability. The focus is treating patients who are at risk of being perceived as “less than likeable, disruptive, and uncooperative.”

, Ms Grant describes her life as wrought with chronic anxiety and depression, with a frequent desire to self-medicate with alcohol. Her story includes multiple rehabilitation programs, inpatient psychiatric hospitalizations, and suicide attempts in the context of alcohol use. Borderline and antisocial traits seemed to influence her clinical presentation. She became well-known to the clinic and hospital staff for one incident that involved her throwing a shoe directly at a police officer’s face.

Social and family history was significant for intergenerational 

, involving her mother, father, and maternal grandfather. Ms Grant relates fond memories of her father, yet reports a childhood dominated by physical abuse and neglect, with the notable absence of her mother. She struggled in school and had suspensions and behavioral problems. Ms Grant became pregnant at 17 years of age and dropped out of school. Her partner left during her pregnancy, so she had to stay with her father.

Substance use and psychiatric history started early, with her first drink during her high school freshman year. She describes peers and boyfriends, whom she shared drinks with, as the support system she never got from family. She abstained from alcohol with her first pregnancy but developed postpartum depression and relapsed when her child turned 5 months old. The stressors of raising her child alone exacerbated feelings of 

. Family support was limited, and her romantic relationships did not last long because of alcohol-associated behaviors. Ms Grant had her second child at the age of 20 while in a verbally and physically abusive relationship. Child protective services were involved. When she was 26, her two children were taken away and placed under a cousin’s care; the relationship ended as well.

Her treatment course included striking, intense episodes of intoxication with agitation and suicidality. One involved being verbally aggressive towards employees and customers while intoxicated at a gas station. In the emergency department, declarations of suicidal ideations, a blood alcohol level > 300 mg/dl and a history of complicated withdrawals led to inpatient hospitalization. She was discharged back to outpatient care, having consistently denied suicidality when no longer intoxicated, and declined transfer to a rehabilitation program at the time.

The second incident involved being caught stealing a wallet from another patient in the clinic. Ms Grant denied the theft despite confrontation, so police were called. The police asked to search Ms Grant’s backpack, but she escalated, cursed, and swung at the officers. This led to a physical scuffle in the psychiatrist’s office, that ultimately culminated in Ms Grant sustaining scratches and bruises. She was handcuffed, brought into police custody for refusing to comply with the search, and subsequently charged and incarcerated for a week.

The psychiatrist felt ongoing empathy for the patient struggling with anxiety and alcohol use disorder who had no one else for support. At the same time, it was a difficult decision on whether to continue treatment following the 

. Despite a strong desire to maintain a working relationship that had lasted for years, there was a sense of disappointment, and even anger, towards the dishonest and illegal behaviors that directly affected other patients. There were concerns about the potential for further covert theft or altercations if she were to continue treatment in the clinic. In addition, the psychiatrist had vivid, uncomfortable memories of the office scuffle.

Yet, Ms Grant, just like many with co-occurring disorders, was at very high risk of acute decompensation with perceived abandonment, which cessation of treatment would have been to her. The psychiatrist considered evaluating the decision-making process from a harm-reduction approach. If Ms Grant were to no longer receive treatment in the clinic, she would likely decompensate, with possible increases in aggressive, antisocial behaviors, and substance use. The psychiatrist felt sharing and processing this case with other colleagues was helpful, especially regarding countertransference.

Another consideration was that Ms Grant, as a woman, faced unique challenges to obtaining substance use treatment. 

Women are less likely to seek treatment for AUD

, and multiple barriers have been identified among women compared to men, including gender stereotype roles and societal expectations, even though women are more predisposed to medical complications from alcohol use.

 Women face gaps in employment, economic challenges, and more parental responsibilities compared to men.

 Along with logistic barriers to treatment including transportation issues, limited childcare resources and insurance, and fear of losing children to child protective services, women are more likely than men to attribute alcohol use disorder to character flaws rather than to genetic disposition.

 With these pressures and beliefs, the fact that women have lower rates of substance use treatment compared to men is unsurprising.

Fortunately, recent research indicates that the gender gap of AUD has been narrowing,

 with studies indicating higher satisfaction in women-only treatment programs. Ongoing challenges include limited access to these types of programs and the necessity of further research to identify the effects on engagement and response to treatment.

Ultimately, considering all these factors, the psychiatrist decided to allow Ms Grant to continue clinic treatment, despite reservations from the clinical staff. They worked through these feelings of anger towards Ms Grant, which was helpful not only for a sense of closure for the psychiatrist and to help promote setting treatment boundaries, but also to help Ms Grant identify the consequences of her actions through behavioral chain analysis. It also helped to visualize that despite all that had happened, Ms Grant was doing “the best that she could,” relying on her limited coping skills, unfortunately stunted by 

. This step is essential to avoid judging the patient from a moral standpoint, where maladaptive or disruptive behaviors are viewed as entirely volitional. With this approach, work was able to resume, with her goals largely revolving around maintaining employment to regain custody of her children, and maintaining her current relationship.

The treatment team and Ms Grant’s deeper understanding of her own motivations and 

 served as a catalyst towards treatment adherence and sobriety. She had chronic difficulty trusting and building new relationships, including those with mental health providers. This issue could be compounded by the concept that patients with substance use disorder (SUD) and personality disorders have often encountered judgmental stances and behaviors, even if subtle or unconscious, from healthcare providers. Bias against patients with SUD, legal histories, and personality disorders can occur easily, especially when the patient is perceived to be “behaving badly.”

Organizationally, clinics are rarely set up with enough support to manage severe personality pathology and navigate psychosocial stressors stemming from complex addiction histories. As the development of AUD is complex and multifactorial, treatment is variable and has to incorporate multiple contributing factors including psychological factors, genetics, personality traits, traumatic events, and family dynamics.

 Research indicates some benefits of regular attendance of Alcoholics Anonymous meetings, but this may not be a treatment that works for everyone.

 Project MATCH, sponsored by the National Institute on Alcohol Abuse and Alcoholism compared 3 different types of therapies and found some positive results with each therapy modality, implying that multiple therapeutic approaches can be utilized in addition to medications.

Support for treating physicians and therapists is essential, as patient relapses and failed treatment trials can contribute to feelings of helplessness, anger, and frustration for both patient and treatment provider

 Identifying this in our own self, as well as any subconscious biases, may provide the space to combat the reactions that come with our countertransference and redirect attention towards meeting the patient’s needs

On a biological level, typologies and classifications have been developed to further classify the development and presentations of 

. Ms Grant’s family history, early onset of alcohol use, and history of legal problems correspond with Cloninger type II alcoholism, which has increased genetic predisposition compared to type I.

Cloninger type I alcoholism is typically associated with adult-onset and harm-avoidance behaviors. Differences in personality traits may underscore drinking motivation; type I alcoholism associates alcohol use with anxiety reduction, while type II corresponds to sensation-seeking behaviors. Neurobiological differences between alcoholism subtypes (serotonin levels, monoamine oxidase activities) are also known. However, the type II subset, under the Stockholm study, was found more commonly in men compared to women, whereas type I affects both genders equally. Identifying topology helps clinicians conceptualize a patient’s presentation, anticipate treatment needs, and may help guide medication selection. For example, off-label use of ondansetron works better for early-onset.

 Patients treated with sertraline may respond better if they have less severe AUD.

Personalized treatment plans work best and should include medication in conjunction with psychotherapy. Naltrexone has the benefit of different routes of administration; intramuscular formulation leads to improved compliance/better outcomes compared to oral. Acamprosate, a hepatically safe option, can help increase time to relapse; however, 3 times daily administration may deter adherence. Disulfiram, an example of aversive therapy, can provide physical discomfort to curb drinking, but effectiveness is limited by poor compliance and risk of induced hepatitis/psychosis. Of note, Ms Grant had already tried all of the FDA-approved options for AUD treatment with little success or tolerability.

Thus, off-label medication was considered. Off-label medications for AUD mirror our understanding of the neurobiology of alcohol use. Varenicline (effects on nicotinic acetylcholine receptor), baclofen (GABA receptors), and ondansetron (serotonin 5-HT

 receptor antagonist), are just a few of the many suggested potential treatments given the complex effect of alcohol on the neural pathways.

 Ms Grant was eventually started on topiramate as further studies report improvement of drinking outcomes and quality of life with adjunct therapy with topiramate compared to placebo.

 The addition of topiramate, with an off-label indication, helped reduce Ms Grant’s cravings and days of heavy drinking. The risks of inadequate treatment of AUD, including frequent rehospitalizations, emergency room visits, and further hepatic injury from drinking, were considered much more dire than off-label potential side effects.

The efficacy of selective serotonin reuptake inhibitors for cravings has been sparse, and use for AUD does not follow American Psychiatric Association guidelines; however, studies have also indicated that patients with mental health conditions are more vulnerable to substance use. It is not uncommon to have a comorbid mental health disorder and substance use. Depressive and anxiety symptoms can also stem from alcohol use.

In addition, research indicates that the chronic use of alcohol, repeat periods of abstinence, and withdrawal results in changes in the prefrontal–striatal–limbic (PSL) circuit, which plays a significant role in emotion regulation, decision making, and modulating reward and stress.

 Therefore, the role of antidepressants on serotonin may have potential effects on obsessional thoughts and impulsivity with chronic alcohol use.

 Open discussions with patients regarding current availability of medications and setting realistic expectations of the effects of medications may mitigate the frustrations arising from continued cravings, a common complaint in SUD patients, and counteract the belief that medications alone lead to remission.

When a patient walks out of the office, one question lingers, 

? This may especially be the case in AUD treatment. AUD is complex, multifactorial, and treatment includes taking into consideration biological, psychological, and socioenvironmental factors. We must gently process and elicit the details of one’s life that they might be the most shameful of, in order to address the deeper underlying issues. Identifying our own defenses and countertransference can potentially improve the therapeutic alliance. The presence of personality disorders can also provide an additional challenge while balancing limited resources and constraints a patient may also have that prevent them from utilizing these options. Thankfully, in addition to off-label options, there are 3 FDA approved medications to treat AUD, though they remain woefully underused. 

There are many patients with stories like Ms Grant; however, with prodding, patience, and exploration, positive outcomes can be achieved. Lastly, systemic and organizational structures ought to take into account the complex treatment needs for SUD, and thoughtfully target resources.

Three years after the office scuffle, the outlook has been much brighter; Ms Grant has found stable and supportive housing and has been in remission from alcohol use for the past 2 years. She lives with her husband and cat and attends online 12-step groups. She clearly recalls the struggles she went through during treatment and uses that to prevent her from drinking again. While her past struggles may have been a reason to abandon hope, she is grateful that neither she, nor her psychiatrist, gave up. Her psychiatrist also realizes that while complex cases can be challenging, they also include the most meaningful work and lead to the most personal growth and satisfaction.

psychiatry resident at the Baylor College of Medicine.

is an associate professor and addiction-boarded faculty at Harris Health System in the Menninger Department of Psychiatry and Behavioral Sciences at Baylor College of Medicine.

1. Agabio R, Pisanu C, Luigi Gessa G, Franconi F. 

Sex difference in alcoholism: who is at a greater risk for development of alcoholic complication?

3. Epstein EE, Menges D. Women and addiction. In: McCrady BS, Epstein EE (eds). 

4. Lale R, Sklar M, Wooldridge J, Sarkin A. 

Gender congruence moderates beliefs about the causes of alcohol dependence and major depression.

Treatment interventions for women with alcohol use disorder.

Psychodynamic psychiatry in Clinical Practice

7. Cloninger CR, Sigvardsson S, Bohman M. 

Type I and type II alcoholism: an update.

8. Johnson BA, Roache JD, Javors MA, et al. 

Ondansetron for reduction of drinking among biologically predisposed alcoholic patients: a randomized controlled trial.

Sertraline in the treatment of co‐occurring alcohol dependence and posttraumatic stress disorder. 

Anticraving therapy for alcohol use disorder: a clinical review.

11. Johnson BA, Ait-Daoud N, Akhtar FZ, Ma JZ. 

Oral topiramate reduces the consequences of drinking and improves the quality of life of alcohol-dependent individuals: a randomized controlled trial.

Neuroplasticity and predictors of alcohol recovery.

Treating patients who may be perceived as “unlikeable” can be difficult. 

To Treat or Not to Treat? The Conundrum of Likeability

Precision medicine took another step forward as Adial Pharmaceuticals announced their intent to enter the genetic testing market. The news comes after the company received a Notice of Allowance from the US Patent and Trademark Office related to use of their genetic diagnostic panel in combination with their lead product, 

“This new patent related to the use of our genetic diagnostic panel in combination with AD04 for the treatment of AUD and OUD is a major milestone as we believe genetic evaluation of patients can be used to identify individuals that may benefit from AD04. We have been utilizing the genetic panel covered by this patent in our ongoing ONWARD™ Phase 3 trial, and, given this patent allowance, we anticipate that genetic diagnostics are expected to be an important segment of our commercial strategy going forward,” Adial’s CEO, William Stilley, said in a statement to the press. “Our view that AUD has a solid nexus in genetics is fundamental to the premise of the successful Phase 2B trial of AD04 conducted at the University of Virginia and our ONWARD™ Phase 3 trial of AD04 currently underway in Europe. And, it is consistent with Adial’s premise that the presence of certain genetics is expected to substantially influence whether an individual suffering from AUD or OUD would likely respond to treatment with AD04.”

 is a genetically targeted therapeutic agent for the treatment of AUD. The drug is designed to reduce cravings thereby reducing alcohol intake. patients curb their drinking. The oral medication will not require abstinence before or during treatment. To date, it has shown positive safety and tolerability profiles.

Once issued, the patent is anticipated to provide market exclusivity for the AD04 genetic diagnostic test. With this in mind, Adial plans to enter the genetic testing market as a stand-alone commercial business line and market the genetic diagnostic panel as a Companion Diagnostic Test to AD04. Approximately one-third (33%) of AUD patients are expected to respond to treatment with AD04.

In addition to the benefits for patients, the resulting efficacy may also realize cost savings to the health care industry. “Market research conducted by Adial indicates a willingness among payors to reimburse a genetic companion diagnostic test, and this may allow Adial to provide patients personalized, precision medicine and also potentially provide dramatic cost savings to payors,” Stilley said further.

1. Adial Pharmaceuticals. Adial Pharmaceuticals plans to enter genetic testing market following allowance of US Patent for genetic diagnostic test. News release. June 22, 2021. Accessed June 22, 2021. 

https://ir.adialpharma.com/press-releases/detail/122/adial-pharmaceuticals-plans-to-enter-genetic-testing-market

2. Adial Pharmaceuticals. Technology. Accessed June 22, 2021. 

Adial’s AD04 for the treatment of alcohol use disorder received a Notice of Allowance from the US Patent and Trademark Office. 

Patent Brings Psychiatry One Step Closer to Precision Medicine

The Acting Administrator of the Drug Enforcement Administration has removed samidorphan (3-carboxamido-4-hydroxy naltrexone) and its salts from the schedules of the Controlled Substances Act.

Samidorphan, a chemical entity that is structurally similar to naltrexone, was a schedule II controlled substance, as it can be derived from opium alkaloids.

One psychiatrist and clinical investigator in favor stated that, “…samidorphan counters weight gain associated with clinical use of olanzapine as antipsychotic medication and this combination product offers significant advancement relative to olanzapine alone…”

Review of scientific and medical evaluations of samidorphan, as well as the recommendation to decontrol samidorphan from the US Department of Health and Human Services, bolstered this decision.

This action effectively removes regulatory controls and any administrative, civil, or criminal sanctions for controlled substances on samidorphan.

1. Drug Enforcement Administration. Schedules of controlled substances: removal of samidorphan from control. 

https://www.federalregister.gov/documents/2021/04/19/2021-07884/schedules-of-controlled-substances-removal-of-samidorphan-from-control

The Drug Enforcement Administration has freed this formerly schedule II controlled substance. 

Samidorphan: Scheduled Substance No More

Binge drinking is defined as consumption of 5 or more standard drinks on 1 occasion for males, or 4 or more for females, bringing blood alcohol concentration to 0.08 grams of alcohol per deciliter or higher.

 These drinking patterns lead to serious health and safety risks, including 

 from unintentional injuries such as motor vehicle crashes,

 suicide attempts as well as other mental health issues, legal charges, and, over the long term, damage to the liver and other organs.

Perhaps not surprisingly, national surveys have found that half of full-time 

 aged 18 to 22 years consumed alcohol in the previous month, and one-third engaged in binge drinking.

 In addition to the previously noted negative impacts, academic performance is also compromised, with 1 in 4 students endorsing academic difficulties (ie, missing class or falling behind on assignments) due to alcohol consumption.

 to perform poorly on tests and projects compared with those who drink but do not binge (40% vs 7%) and are 5 times more likely to miss a class.

 Although not all individuals who drink develop an addiction, consumption and especially binge drinking patterns are often preludes to an addiction, with approximately 9% of college students meeting criteria for alcohol use disorder.

 Lack of screening may also underestimate the magnitude of the problem.

The first few weeks of freshman year are often a period of heavy drinking and alcohol-related consequences. Social pressures and expectations during new-found independence, widespread availability and access to alcohol, unstructured schedules with mounting academic pressure, and lack of parental interactions all play a role. Alongside these stressors, many students have preexisting personality traits that may account for the use and misuse of alcohol during college.

Neuroticism, 1 of the 5 higher order personality traits, is defined by high emotional instability, depressed mood, low frustration tolerance, and anxiety. It also has been found to positively predict alcohol consumption (social intake within recommended parameters)

 and alcohol use (intake beyond recommended parameters that can lead to addiction).

 Only 1 previous study of 200 college students evaluated the implications of personality types; that study found high neuroticism and low conscientiousness predicted more 

aimed to better understand the role of personality and neuroticism in college alcohol use/misuse among freshman, above and beyond the reported levels of stress. The starting hypothesis revolved around the notion that negative affect faces of neuroticism, and primarily 

, are more strongly associated with alcohol use and misuse than stress when accounting for other personality domains.

 conducted a cross-sectional outpatient study, which was approved by the Institutional Review Board. Survey data was collected from participants during the first 8 weeks of their first college semester. Participants included 211 female and 90 male matriculating college freshmen with an average age of 18.58 years (SD = 0.39) from 2 campuses of a private university in the southeastern United States, spanning both urban and rural areas. Students were recruited via fliers posted on campus and during frequent in-person undergraduate events.

Data was acquired via online surveys of behavioral, health questionnaires, and cognitive assessments. Most surveys were completed within 3 weeks of the study initiation, and participants received a $15 gift card for completion. The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) and the Alcohol Use Disorders Identification Test (AUDIT) were used to assess alcohol use and misuse (

Endorsement of use 1 or more times on the ASSIST prompted the administration of the AUDIT, a 10-item questionnaire with a maximum score of 40 for which the higher scores indicate more severe and hazardous, harmful, excessive alcohol use/misuse. Stress was assessed using the Perceived Stress Scale (PSS), a 14-item self-reported measure of stress with each stress symptom scored on a 4-point Likert scale, where 0 = never and 4 = very often (maximum score of 56). Personality was assessed using the 44-item version of the Big Five Inventory (BFI), which measures 5 dimensions of personality (openness to experience, conscientiousness, extraversion, agreeableness, and neuroticism).

Ten facet traits were also calculated to assess more specific personality characterization within the 5 domains: openness, aesthetics, and ideas; conscientiousness, order, and self-discipline; extraversion, assertiveness, and activity; agreeableness, altruism, and compliance; and neuroticism, anxiety, and depression.

Although college drinking develops into an addiction, overconsumption and especially binge drinking patterns are often preludes to alcohol use disorder, with approximately 1 in 10 students meeting criteria for AUD.

Alcohol Abuse

Everyone Relapses Anyway. Or Do They?

10 Questions on Holiday Spirits

How to Talk to Teenagers About Substance Use

To Treat or Not to Treat? The Conundrum of Likeability

Patent Brings Psychiatry One Step Closer to Precision Medicine

Samidorphan: Scheduled Substance No More

Exploring the Link Between Neuroticism-Depression and College Drinking

Hitting the Fast Track: Alcohol Use Disorder Treatment Filing with FDA

Underused Medication May Be Best Bet for Comorbid AUD and Depression

Neuroticism-Depression: What Is It and Does It Play a Role in College Drinking?