Varenicline for Alcoholism

(HARP Trial)

Overseen By June-Marie Weiss, MA, MEd

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Yale University

Must not be taking: Alcohol treatment medications

Disqualifiers: Pregnancy, Opioid use disorder, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This study seeks to determine the feasibility, acceptability, and preliminary efficacy of an intervention consisting of off-label use of a medication with strong efficacy data for alcohol use disorder (AUD) with medical management and a clinical pharmacist-delivered behavioral intervention in reducing alcohol use among individuals with HIV and AUD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications that interact with the study drug, like nicotine replacement therapy.

What data supports the effectiveness of the drug varenicline for treating alcoholism?

Research suggests that varenicline, a drug originally approved to help people stop smoking, may also help reduce alcohol use. Some studies have shown promise in its ability to decrease drinking among people seeking treatment for alcohol problems. ^{1 2 3 4 5}

Is varenicline safe for humans?

Varenicline is generally considered safe for helping people quit smoking, but it can cause side effects like severe stomach pain and has been linked to some mental health issues in a small number of people. It's important to monitor for these effects, especially in people with existing mental health conditions. ^{2 3 6 7 8}

How does the drug varenicline differ from other treatments for alcoholism?

Varenicline, originally approved for helping people quit smoking, is unique in its potential to reduce alcohol cravings and consumption by affecting the brain's reward system, which is different from traditional alcohol treatments that often focus on managing withdrawal symptoms or using behavioral therapies. ^{4 9 10 11 12}

Research Team

E. Jennifer Edelman, MD, MHS

Principal Investigator

Yale University

Eligibility Criteria

This trial is for adults over 18 with HIV and moderate to severe alcohol use disorder, receiving care at the Atlanta VA Healthcare System. Participants must be current smokers, on multiple medications, have a high level of recent alcohol use indicated by PEth test, and able to consent. Pregnant or nursing individuals, those with life-threatening conditions or untreated opioid disorders are excluded.

Inclusion Criteria

Receive care at the Atlanta VA Healthcare System

Meet criteria for moderate to severe alcohol use disorder by the DSM-5 Alcohol Symptom Checklist

Can provide written informed consent

Exclusion Criteria

History of serious hypersensitivity or adverse reaction to study medication

Self-report or laboratory test confirming pregnancy, nursing, or trying to conceive

I do not have any severe health or mental conditions that would stop me from participating.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive a 12-week intervention including off-label use of medication with medical management and a clinical pharmacist-delivered behavioral intervention

12 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Varenicline

Trial Overview The study tests Varenicline's off-label effectiveness in reducing alcohol consumption among HIV patients with AUD. It combines medication with medical management and behavioral interventions delivered by a clinical pharmacist.

Participant Groups

Group I: Varenicline Experimental Treatment 1 Intervention

Participants will receive a prescription for generic varenicline

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Findings from Research

Varenicline has been shown to effectively reduce alcohol cravings and overall alcohol consumption in patients with alcohol use disorders, based on data from 7 randomized, placebo-controlled trials and 1 open-label study.

While varenicline helps decrease drinking behavior, it does not significantly improve the rates of abstinence from alcohol, indicating its role may be more about managing cravings rather than achieving complete sobriety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Varenicline in the treatment of alcohol use disorders. Erwin, BL., Slaton, RM.[2018]

Varenicline is an effective treatment for nicotine addiction, promoting abstinence safely in most patients, but there are reports of neuropsychiatric adverse events in a small number of cases.

Veterans, who often have higher rates of psychiatric conditions and nicotine dependence, may be at increased risk for serious side effects from varenicline, highlighting the need for close monitoring in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse neuropsychiatric events associated with varenicline use in veterans: a case series. Cantrell, M., Argo, T., Haak, L., et al.[2015]

References

1. England pubmed.ncbi.nlm.nih.gov

The effect of varenicline on smoking and drinking outcomes among Black and White adults with alcohol use disorder and co-occurring cigarette smoking: A secondary analysis of two clinical trials. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Efficacy and acceptability of varenicline for alcoholism: A systematic review and meta-analysis of randomized-controlled trials. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Varenicline in the treatment of alcohol use disorders. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

The role of varenicline on alcohol-primed self-administration and seeking behavior in rats. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Neuropsychiatric disturbance after initiation of varenicline in a patient with a history of alcohol abuse and major depression. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Varenicline treatment of concurrent alcohol and nicotine dependence in schizophrenia: a randomized, placebo-controlled pilot trial. [2017]

7. England pubmed.ncbi.nlm.nih.gov

Adverse neuropsychiatric events associated with varenicline use in veterans: a case series. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

The Impact of Varenicline on Alcohol Consumption in Subjects With Alcohol Use Disorders: Systematic Review and Meta-Analyses. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Suicide Attempt in a 38-Year-Old Patient on Varenicline While Intoxicated With Alcohol. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Varenicline in Patients With Severe Alcohol Dependence: A Pilot Double-Blind Randomized and Controlled Study. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

A preliminary investigation of varenicline for heavy drinking smokers. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Effects of Varenicline on Neural Correlates of Alcohol Salience in Heavy Drinkers. [2019]