Buproprion for Binge Drinking

August 24, 2020 updated by: James Garbutt, MD, University of North Carolina, Chapel Hill

Efficacy and Safety of the Melanocortin Activator Bupropion in Treating Binge Drinking

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.

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Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The design is a 1:1 random assignment to placebo or bupropion XL (extended release) (300mg/d). The study biostatistician, will prepare the randomization schedule and include blocking by gender and nicotine dependence. Randomization will be based on a stratified block design, with gender and nicotine dependence as the stratification variables with medication/placebo randomly assigned in blocks of four.

Bupropion XL will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84. The University of North Carolina (UNC) Hospital's Investigational Drug Services (IDS) will prepare opaque capsules containing bupropion XL 150/300 mg and matching placebo. Capsules will be inserted into blister packs with each pack containing 1 week of medication. The IDS will receive the randomization schedule from our statistician and prepare the blister packs according to the blocked schedule with blocking for gender/nicotine dependence.

Recruitment, Telephone Screen, and Full Eligibility Screening: Subjects will initially be prescreened by phone and then at full screening read and sign the informed consent. A breathalyzer test will be administered (must be 0.00 gms/dl to give informed consent), height, weight and BMI recorded and a medical history and examination completed. Over-the-counter and prescription medication use will be recorded and nicotine use documented. Complete Blood Count (CBC) with differential; serum bilirubin, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Gamma-Glutamyl Transferase (GGT,) sodium, potassium, chloride, blood urea nitrogen, creatinine, glucose; and urinalysis and urine toxicology completed. Women will be given a urine pregnancy test (Ub-HCG) at screening and at weeks 4, 8, and 12. Trained interviewers will conduct the psychiatric screening interview using the M.I.N.I. . The Structured Clinical Interview (SCID) Substance Use Disorders Module to establish Diagnostic and Statistical Manual (DSM-V) criteria for alcohol use disorders will be administered by one of the study doctors. The study coordinator will conduct the pretreatment 90-day Timeline Followback (TLFB) interview to identify amount of alcohol consumed and timeframe of consumption. A binge drinking episode requires a minimum of 5/4 (men/women) standard drinks consumed over about a two hour period, i.e. consuming a bottle of wine over five hours would not be coded as a binge drinking day. The Penn Alcohol Craving Scale (PACS) and the University of Rhode Island Change Assessment (URICA) will be completed and treatment goal-abstinence vs. reduction- recorded.

Initial Treatment Visit (within 21 days screening): Eligible individuals will not be required to abstain from drinking alcohol prior to randomization. The study coordinator will administer a breathalyzer test (BAC must be ≤0.04 gms/d) and complete assessments as outlined in Table 1, Protection of Human Subjects. A salivary cotinine sample will be taken A 1-week blister pack of bupropion-XL or placebo with written instructions will be dispensed from the Investigational Drug Services according to the randomization block along with a 1-week back-up blister pack in case of delayed appointments or lost doses. Bupropion-XL will be titrated with 150 mg given daily for 4 days followed by 300 mg/d. Participants will be given a calendar style diary to track pill taking, drinking quantity/timing, intoxication and any side effects. Finally, participants will receive Medical Management from a trained clinician.

Subsequent Treatment Visits: TLFB and PACS are gathered each visit, cotinine samples at weeks 4, 8 and 12 and URICA at week 8. Medical monitoring will be conducted by study physicians and will consist of review of vital signs, concomitant medication use, and general inquiries into side effects. The physician may recommend that medication be held for a period of time to deal with an adverse event, e.g. nausea. One month and three months following the last visit subjects will be contacted by phone to update drinking (TLFB), adverse effects and medications.

Medical Management Intervention: The psychosocial support for the study will be Medical Management (MM). MM sessions average 10-15 minutes and focus on three main areas: (1) feedback on consequences of drinking; (2) encouraging compliance with medication/addressing compliance problems and (3) encouraging progress towards drinking goal- reduction or abstinence are acceptable. 10% of sessions will be audiotaped and reviewed to enhance fidelity.

Medication Compliance Monitoring: Participants will record their pill taking in calendar-style diaries that will be provided and collected at each visit. Pills will be distributed in blister packs that will be returned to the study coordinator to reconcile any unused medication from the returned blister packs with participants' diary records.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Men and women between the ages of 21 and 44 years.
  2. 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.
  3. Ability to understand and sign written informed consent.
  4. Must have a 0.0 gms/dl breathalyzer reading on the day of screening and 0.0 gms/dl on the day of randomization.
  5. BMI ≥18.5 (normal weight or above)
  6. Express a desire to achieve abstinence or to reduce alcohol consumption
  7. Must have a stable residence and be able to identify an individual who could contact participant if needed.

Exclusion Criteria:

  1. 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).
  2. Bupropion is contraindicated in individuals with a history of bulimia or a seizure disorder
  3. 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.
  4. Other substance abuse or dependence disorder other than nicotine or cannabis abuse.
  5. 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.
  6. AST or ALT > 3.5 times Upper Limit of Normal (ULN) or bilirubin > 1.5 X ULN.
  7. 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.
  8. 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).
  9. Women who are breastfeeding.
  10. Individuals requiring inpatient treatment or more intense outpatient treatment for their alcohol problems.
  11. Participation in any clinical trial within the past 60 days that would have safety concerns for the trial.
  12. Court-mandated participation in alcohol treatment or pending incarceration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Bupropion
Bupropion extended release
Drug: Bupropion
Bupropion XL will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84.
Other Names:
  • Wellbutrin Extended Release
Placebo Comparator: Placebo
Placebo oral tablet
Drug: Placebo Oral Tablet
Placebo will be initiated on Day 1 and continue throughout the course of the study.
Other Names:
  • Sugar pill

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Proportion of Binge Drinking Days
Time Frame: Randomization (Week 0) to Week 12
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
Time Frame: Randomization (Week 0) to Week 12
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in GGT
Time Frame: Randomization (Week 0) to Week 12
Change in serum Gamma-glutamyltransferase (GGT) levels
Randomization (Week 0) to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James C Garbutt, UNC Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 4, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 19, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 17, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-1064
  • 1R21AA025186-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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