An Open Label Trial of Bupropion and Naltrexone for Binge Drinking

NCT02842073 | Completed Phase 2 Results

• 2 other identifiers: 16-1370TTSA018P1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label Phase IIa pilot study of the tolerability and effects on binge drinking of bupropion and naltrexone for binge drinkers.

Conditions

Binge Drinking

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Treatment-Associated Adverse Events

  Tolerability assessed by specifically probing for intervention-associated adverse effects.

  12 weeks

• Number of Participants Discontinuing Subsequent to Defined Intolerance

  Retention was evaluated indirectly by accounting for those participants who discontinued either naltrexone or bupropion or study participation itself due to intolerance.

  Throughout study, a total of approximately 12 weeks

• Number of Binge Drinking Days During Treatment

  The number of binge drinking days during treatment with bupropion + naltrexone

  12 weeks

Secondary Outcomes (2)

• Final Penn Alcohol Craving Scale (PACS) Score

  12 weeks

• Mean Number of Drinks/Binge Drinking Day During Treatment

  12 weeks

Study Arms (1)

Naltrexone and Buproprion

EXPERIMENTAL

Investigators will use standard clinical doses of bupropion-XL 300 mg/d (lower seizure risk) and naltrexone 50 mg/d dispensed by the UNC Investigational Drug Services. Bupropion XL will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84. Naltrexone will be initiated at 25 mg/d from Days 7-9 and then go to 50 mg/d for Days 10-84.

Drug: Naltrexone; Drug: Bupropion

Interventions

Naltrexone DRUG

Standard clinical doses of naltrexone 50 mg/d dispensed by the UNC Investigational Drug Services. Naltrexone will be initiated at 25 mg/d from Days 7-9 and then go to 50 mg/d for Days 10-84.

Naltrexone and Buproprion

Bupropion DRUG

Standard clinical doses of bupropion-XL 300 mg/d (lower seizure risk) dispensed by the UNC Investigational Drug Services. Bupropion XL will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84.

Naltrexone and Buproprion

Eligibility Criteria

• Age: 21 Years - 34 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women between the ages of 21 and 34 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.
• Must have a stable residence and be able to identify an individual who could contact participant if needed.
• Have a goal of sobriety or significantly reducing alcohol intake.

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 and naltrexone is contraindicated in acute liver disease and in patients using or misusing opioids.
• 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 or naltrexone.
• AST or ALT \> 3.5 times 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
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Binge Drinking

Interventions

Naltrexone; Bupropion

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Propiophenones; Ketones; Organic Chemicals

Results Point of Contact

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

jc_garbutt@med.unc.edu

984-974-2201

Study Officials

• James Garbutt

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: July 22, 2016
• Study Start: November 1, 2016
• Primary Completion: December 13, 2017
• Study Completion: December 13, 2017
• Last Updated: December 26, 2018
• Results First Posted: December 26, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)