Buproprion for Binge Drinking

NCT03169244 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 16-10641R21AA025186-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The present proposal is an innovative and translational clinical trial derived from exciting preclinical findings to test the hypothesis that treatment with the melanocortin activator bupropion can reduce binge drinking in humans. Furthermore, pilot data on moderating effects of coexisting nicotine use on the efficacy of bupropion for binge drinking population will be obtained. Evidence for an efficacy signal with good tolerability with this FDA approved medication would form the foundation to conduct a well-powered Phase II b trial. The development of an effective pharmacotherapy for binge drinking would be a significant clinical advance. .

Conditions

Alcohol Abuse

Outcome Measures

Primary Outcomes (2)

• Change in Proportion of Binge Drinking Days

  Frequency is assessed as number of binge episodes/time in trial controlling for missing data.

  Randomization (Week 0) to Week 12

• Change in the Intensity of Binge Drinking

  Intensity is defined as the number of drinks per binge day scaled by the minimum threshold of a binge episode per gender (4 drinks/day for females; 5 drinks/day for males). Accordingly, if a female consumed 4 drinks in a binge drinking day, the intensity would be 1.0 and a female who consumed 6 drinks in a binge drinking day would have an intensity of 1.5.

  Randomization (Week 0) to Week 12

Secondary Outcomes (1)

• Change in GGT

  Randomization (Week 0) to Week 12

Study Arms (2)

Bupropion

ACTIVE COMPARATOR

Bupropion extended release

Drug: Bupropion

Placebo

PLACEBO COMPARATOR

Placebo oral tablet

Drug: Placebo Oral Tablet

Interventions

Bupropion DRUG

Bupropion XL will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84.

Also known as: Wellbutrin Extended Release

Bupropion

Placebo Oral Tablet DRUG

Placebo will be initiated on Day 1 and continue throughout the course of the study.

Also known as: Sugar pill

Placebo

Eligibility Criteria

• Age: 21 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women between the ages of 21 and 44 years.
• A minimum of 5/3 (men/women) or more binge drinking episodes per month over the past three months. A binge drinking episode is defined as the consumption of 5/4 (men/women) standard drinks (\~12 gms ethanol) in about a two hour period. Subjects may meet DSM-V criteria for mild or moderate alcohol use disorder.
• Ability to understand and sign written informed consent.
• Must have a 0.0 gms/dl breathalyzer reading on the day of screening and 0.0 gms/dl on the day of randomization.
• BMI ≥18.5 (normal weight or above)
• Express a desire to achieve abstinence or to reduce alcohol consumption
• Must have a stable residence and be able to identify an individual who could contact participant if needed.

You may not qualify if:

• Presence of physical dependence on alcohol as assessed by clear tolerance to alcohol or alcohol withdrawal symptoms based on SCID interview or a Severe Alcohol Use Disorder (\>5 SCID DSM-V symptoms).
• Bupropion is contraindicated in individuals with a history of bulimia or a seizure disorder
• Clinically significant medical disease that might interfere with the evaluation of the study medication or present a safety concern (e.g., renal insufficiency, cirrhosis, unstable hypertension, diabetes mellitus, seizure disorder). Clinically significant psychiatric illness including any psychotic disorder, bipolar disorder, anorexia/bulimia, severe depression, or suicidal ideation.
• Other substance abuse or dependence disorder other than nicotine or cannabis abuse.
• Concurrent use of anticonvulsants. Concurrent use of any psychotropic medication including antidepressants, mood stabilizers, antipsychotics, anxiolytics, stimulants, or hypnotics with the exception of stable doses of antidepressants for one month. Bupropion is commonly added to antidepressants for augmentation so the use of another antidepressant does not represent a safety concern. .Prior history of adverse reaction to bupropion.
• AST or ALT \> 3.5 times Upper Limit of Normal (ULN) or bilirubin \> 1.5 X ULN.
• Positive urine toxicology screen with the exception of cannabis. Individuals with positive cannabis screens will be excluded only if they have a history of cannabis dependence.
• Pregnant women and women of childbearing potential who do not practice a medically acceptable form of birth control (oral or depot contraceptive, or barrier methods such as diaphragm or condom with spermicidal).
• Women who are breastfeeding.
• Individuals requiring inpatient treatment or more intense outpatient treatment for their alcohol problems.
• Participation in any clinical trial within the past 60 days that would have safety concerns for the trial.
• Court-mandated participation in alcohol treatment or pending incarceration.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Bupropion; Sugars

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Carbohydrates

Results Point of Contact

• Title: James C. Garbutt, MD
• Organization: University of North Carolina at Chapel Hill

jc_garbutt@med.unc.edu

919-445-0205

Study Officials

• James C Garbutt

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The design is a 1:1 random assignment to placebo or bupropion XL (300mg/d).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 30, 2017
• Study Start: September 4, 2017
• Primary Completion: August 19, 2019
• Study Completion: September 17, 2019
• Last Updated: August 26, 2020
• Results First Posted: August 26, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)