Medication Screening Models for Alcoholism

Overseen By Meaghan Lavery

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Neurological, Cardiovascular, Endocrine, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two models, Model 1 and Model 2, to evaluate their effectiveness in screening medications for Alcohol Use Disorder (AUD). The models aim to understand how various factors influence the urge to drink and the amount consumed when alcohol is available. Participants will attend sessions where they encounter alcohol cues and have the opportunity to drink in a controlled setting. Individuals who have been drinking heavily and meet specific criteria for AUD over the past six months may be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could improve screening methods for AUD.

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are currently being treated for drinking or have taken any investigational drug within 4 weeks, you may be excluded.

What prior data suggests that these models are safe for screening AUD medications?

Research has shown that the two methods tested in this study are safe ways to examine Alcohol Use Disorder (AUD). These methods involve observing how various factors affect drinking behavior in a controlled environment, simulating real-life situations where alcohol might be available and tempting.

In these methods, participants receive a small amount of alcohol to observe how quickly they choose to drink more. Model 1 examines how alcohol cues and availability influence drinking, while Model 2 includes a small initial dose of alcohol. Past research has not reported any specific negative effects directly linked to these methods. However, both involve controlled exposure to alcohol, and safety measures protect participants.

Since this study does not involve new medications or invasive procedures, the risks remain generally low. The controlled setting helps minimize any potential harm from drinking alcohol. Participants should discuss any concerns with the researchers before joining the study to fully understand the process and any possible risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Medication Screening Models for Alcoholism trial because it explores the psychological triggers and environmental factors affecting alcohol consumption. Unlike traditional treatments like medications or behavioral therapies that directly aim to reduce alcohol intake, this trial focuses on understanding how cues and availability influence drinking behavior. Model 1 examines these factors' impact on how quickly a person starts drinking and how much they consume. Model 2 adds a twist by including a priming dose of alcohol to see its effect. This approach could lead to more personalized and effective intervention strategies by identifying key behavioral patterns associated with alcohol use.

What evidence suggests that this trial's models could be effective for screening AUD medications?

This trial will compare two experimental models for managing Alcohol Use Disorder (AUD). Research shows that both Model 1 and Model 2 could help manage AUD. Participants may be assigned to Model 1, where studies have found that certain care methods can significantly reduce the number of days of heavy drinking. Alternatively, participants may be assigned to Model 2, which combines behavioral therapies and has also led to noticeable reductions in heavy drinking compared to standard care. Both models focus on how alcohol triggers and availability affect drinking habits. Model 2 includes a small initial dose of alcohol to observe changes in drinking behavior during the test. These methods have shown promise in helping people delay drinking and consume less alcohol. ^{6 7 8 9 10}

Who Is on the Research Team?

Sherry McKee, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults aged 21-65 who meet the criteria for Alcohol Use Disorder (AUD), consuming more than a moderate amount of alcohol weekly. They must have no major responsibilities after sessions, be able to read/write English, and not seeking AUD treatment. Excluded are those with severe mental health issues, significant medical conditions, recent investigational drug use, pregnancy/nursing without contraception, or high risk of withdrawal.

Inclusion Criteria

Laboratory sessions will be scheduled such that participants will not have major responsibilities on the following day which might limit drinking during the self-administration session (e.g., job interview, exam)

I drink more than the specified weekly limit for my gender.

Able to read and write English

Exclusion Criteria

Suicidal, homicidal or evidence of current (past 6-month) diagnosis of schizophrenia, or bipolar disorder, or psychosis. Participants diagnosed with psychiatric disorders not specifically listed above may be included at the discretion of the study MD as long as the concurrent treatment for the comorbid psychiatric condition does not compromise the study integrity by virtue of its type, duration, or intensity

Only one member per household can participate in the study

Participants who have taken any investigational drug within 4 weeks of intake

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intake Session

Participants undergo an intake session and a physical exam

1 week

1 visit (in-person)

Laboratory Sessions

Participants engage in two laboratory sessions involving alcohol cue presentation and self-administration options

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after laboratory sessions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Model 1
• Model 2

Trial Overview The study aims to develop two 'ability to resist' drinking models (Model 1 and Model 2) that could help in screening medications for treating AUD. Participants will try these models under controlled lab conditions to see how effective they might be in resisting alcohol consumption.

How Is the Trial Designed?

Group I: Model 2 Experimental Treatment 2 Interventions

Model 2 examines the impact of alcohol cues and alcohol availability and a priming dose of alcohol (.04 g/dL) on latency to start drinking and amount consumed of a 0.12 g/dL dose of alcohol during a 2-hour ad-libitum period.

Group II: Model 1 Experimental Treatment 2 Interventions

Model 1 examines the impact of alcohol cues and alcohol availability on latency to start drinking and amount consumed of a 0.12 g/dL dose of alcohol during a 2-hour ad-libitum period.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Published Research Related to This Trial

Naltrexone, acamprosate, and disulfiram are effective medications approved for treating alcoholism, primarily by reducing cravings, which are linked to neurobiological mechanisms.

Combining anticraving medications, like naltrexone and acamprosate, may improve treatment outcomes, highlighting the need for further research on optimal dosing and strategies to improve patient adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medications and alcohol craving. Swift, RM.[2019]

Naltrexone is the most studied medication for alcohol dependence in the U.S., showing promise, but no medication has yet been proven effective for the average alcoholic in routine treatment.

Future research aims to identify specific subgroups of alcohol-dependent individuals who may respond better to certain medications, which could enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent developments in the pharmacotherapy of alcohol dependence. Schuckit, MA.[2019]

In a study involving individuals with alcohol use disorder (AUD), no significant effects were found for naltrexone or varenicline on reducing drinking days or increasing abstinence during a 6-day practice quit attempt, suggesting these medications may not be effective in this specific short-term model.

Despite the lack of medication effects during the practice quit period, participants showed a notable reduction in drinking over the entire 13-day treatment period, indicating that intrinsic motivation to change plays a crucial role in achieving abstinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A practice quit model to test early efficacy of medications for alcohol use disorder in a randomized clinical trial. Ray, LA., Baskerville, WA., Nieto, SJ., et al.[2023]

In a study of 1168 participants with alcohol use disorder, consecutive days of abstinence prior to treatment were strong predictors of achieving abstinence and having no heavy drinking days during the last 4 weeks of treatment.

Younger individuals and older individuals with higher Alcohol Dependence Scale scores were less likely to have no heavy drinking days, indicating that age and baseline dependence levels can influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of abstinence, no heavy drinking days, and a 2-level reduction in World Health Organization drinking levels during treatment for alcohol use disorder in the COMBINE study. Wallach, JD., Gueorguieva, R., Phan, H., et al.[2023]

Currently, three medications—disulfiram, naltrexone, and acamprosate—are approved for treating alcoholism, but their effectiveness is moderate, and not all patients respond to them.

Future development of alcohol use disorder medications faces challenges such as identifying drug targets, validating screening models, and engaging healthcare practitioners to use these treatments effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of medications for alcohol use disorders: recent advances and ongoing challenges. Litten, RZ., Fertig, J., Mattson, M., et al.[2007]

Current medications like naltrexone and acamprosate show limited effectiveness in preventing relapse in alcoholics, indicating a need for further research and development of new treatments.

There is potential for improved outcomes through treatment matching for specific subgroups of alcoholics, and ongoing studies are necessary to determine optimal dosing strategies and the effectiveness of combination therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of alcoholism: gaps in knowledge and opportunities for research. Kranzler, HR.[2019]

A systematic review of 156 trials involving 27,334 participants found that medications like acamprosate, disulfiram, baclofen, and oral naltrexone significantly improve total abstinence and reduce heavy drinking in adults with alcohol use disorders (AUDs).

While some medications like nalmefene and fluvoxamine were associated with higher dropout rates due to adverse events, baclofen and pregabalin resulted in fewer dropouts compared to placebo, indicating a better safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapies for Adults With Alcohol Use Disorders: A Systematic Review and Network Meta-analysis. Bahji, A., Bach, P., Danilewitz, M., et al.[2023]

Education sessions significantly increased the dispensing rates of Naltrexone for treating alcohol use disorder, with rates rising 2.47 times, 3.7 times, and 4.81 times after successive presentations.

The study also found that these educational efforts led to a 35% reduction in emergency department visits and a 21% decrease in hospital admissions for alcohol use disorder, highlighting the potential of pharmacotherapy combined with counseling to improve treatment outcomes and reduce healthcare system demands.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How prescribing available pharmacotherapies for alcohol use disorder can impact the healthcare system: A retrospective quality improvement study. Szelest, I., Harries, B., Motluk, L., et al.[2021]

The paper discusses five basic models of chemical dependency, highlighting that effective treatment requires flexibility in combining elements from these models to create individualized treatment plans for substance abusers.

The dual diagnosis model is emphasized as a multifocused approach that integrates aspects of different models, allowing for a broader treatment focus that can address coexisting disorders alongside chemical dependency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment implications of chemical dependency models an integrative approach. Brower, KJ., Blow, FC., Beresford, TP.[2019]

The COMBINE Study successfully adapted the Systematic Assessment for Treatment Emergent Events (SAFTEE) to standardize the assessment of adverse events for naltrexone and acamprosate in treating alcohol dependence, ensuring consistent and reliable data collection.

The SAFTEE demonstrated high fidelity and flexibility in measuring adverse events across various settings, suggesting it could be a valuable tool for future clinical studies evaluating the safety and efficacy of new therapeutic drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The COMBINE SAFTEE: a structured instrument for collecting adverse events adapted for clinical studies in the alcoholism field. Johnson, BA., Ait-Daoud, N., Roache, JD.[2019]

Pharmacological treatments for alcohol use disorders (AUD), such as acamprosate, naltrexone, nalmefene, and disulfiram, are effective but underused, highlighting the need for better implementation despite their proven efficacy.

Each medication has a distinct safety profile that must be carefully considered alongside individual patient circumstances, including their drinking patterns and any comorbid conditions, to optimize treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of Pharmacological Treatment of Alcohol Dependence: Comprehensive Review of Evidence. Sinclair, JM., Chambers, SE., Shiles, CJ., et al.[2018]

A study analyzing health care records of 86,207 patients found that defining episodes of alcoholism treatment is sensitive to the minimum number of treatment encounters, with 43% to 77% of patients having at least one treatment episode.

The most reliable definition of an alcoholism treatment episode involves 3 to 4 treatment encounters followed by a clear zone of 3 to 4 months without encounters, which helps in accurately identifying treatment patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcoholism treatment episodes validly defined using mental health care utilization records. Wall, MM., Stromberg, KD., Pothoff, S., et al.[2018]

Citations

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A randomized trial testing digital medicine support models ... Across all three groups, the percentage of self-reported heavy drinking days dropped from 38.4% at baseline (95% CI [35.8%, 41%]) to 22.5% (19.5 ...

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Alcohol Use Disorder and Common Co-occurring Conditions A model of care for co-occurring AUD and other mental health disorders. Brief tools are available to help non-specialists assess for AUD and ...