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An Open Label Trial of Bupropion and Naltrexone for Binge Drinking

Primary Purpose

Binge Drinking

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Naltrexone
Bupropion
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge Drinking

Eligibility Criteria

21 Years - 34 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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 and naltrexone is contraindicated in acute liver disease and in patients using or misusing opioids.
  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 or naltrexone.
  6. AST or ALT > 3.5 times 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.

Sites / Locations

  • University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Naltrexone and Buproprion

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Associated Adverse Events
Tolerability assessed by specifically probing for intervention-associated adverse effects.
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.
Number of Binge Drinking Days During Treatment
The number of binge drinking days during treatment with bupropion + naltrexone

Secondary Outcome Measures

Final Penn Alcohol Craving Scale (PACS) Score
Craving for alcohol will be assessed using the Penn Alcohol Craving Scale (PACS) The PACS is a five-item self-administered instrument for assessing craving. Frequency, intensity, and duration of thoughts about drinking are assessed along with ability to resist drinking. The final item asks the responder to provide an average rating of his/her craving over the course of the past week. The questions on the PACS use descriptors coupled with numerical ratings ranging from 0 to 6 with the highest possible total score of 30. Higher scores reflect a higher level of craving. This outcome measure is the final PACS total score obtained in the trial.
Mean Number of Drinks/Binge Drinking Day During Treatment

Full Information

First Posted
June 15, 2016
Last Updated
December 3, 2018
Sponsor
University of North Carolina, Chapel Hill
Collaborators
North Carolina Translational and Clinical Sciences Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02842073
Brief Title
An Open Label Trial of Bupropion and Naltrexone for Binge Drinking
Official Title
Assessing Changes in the Brain Melanocortin System and Sensory Processing in Response to Alcohol to Advance Our Understanding of the Pathophysiology and Psychopharmacology of Binge Drinking
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
December 13, 2017 (Actual)
Study Completion Date
December 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
North Carolina Translational and Clinical Sciences Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is an open-label Phase IIa pilot study of the tolerability and effects on binge drinking of bupropion and naltrexone for binge drinkers. Participants: Investigators will recruit 12 men or women ages 21-34 years who exhibit 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. Subjects with overt physical dependence on alcohol, significant medical problems including seizures or bulimia, other substance use disorder except for occasional marijuana (based on toxicology screen) or significant psychiatric illness will be excluded. Procedures (methods): As a first step in human trials investigators will give open label bupropion + naltrexone to active binge drinking subjects. The primary goal here is to assess tolerability and acceptability though changes in binge drinking and subjective sense of "effect" will be gathered as well. Investigators will also test cortical adaptation to binge drinking by completing tactile sensory testing and comparing the results to controls and individuals with overt physical dependence on alcohol. Investigators will recruit subjects using the e-mail listserve for UNC students, faculty and staff. 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. Subjects will be seen at screening and then at Weeks 0, 1, 3, 5, 8 and 12. Subjects will be breathalyzed and receive Medical Management counseling to encourage compliance and progress towards drinking goals. Investigators will use the Time Line Follow-Back approach to assess alcohol consumption history modified to include time taken to consume alcohol and define a binge. They will also measure craving for alcohol and will assess tolerability by probing for adverse effects. Key outcomes of interest include tolerability and acceptability, drinking behavior including frequency and intensity of binge drinking, and craving for alcohol. Because this is an open-label trial without a placebo comparison group no formal statistics will be completed and efficacy will not be assessed. Instead, this pilot study will inform investigators about the recruitment of binge drinkers, the tolerability and acceptability of bupropion/naltrexone in this population and potential efficacy signals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Drinking

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Naltrexone and Buproprion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupropion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Associated Adverse Events
Description
Tolerability assessed by specifically probing for intervention-associated adverse effects.
Time Frame
12 weeks
Title
Number of Participants Discontinuing Subsequent to Defined Intolerance
Description
Retention was evaluated indirectly by accounting for those participants who discontinued either naltrexone or bupropion or study participation itself due to intolerance.
Time Frame
Throughout study, a total of approximately 12 weeks
Title
Number of Binge Drinking Days During Treatment
Description
The number of binge drinking days during treatment with bupropion + naltrexone
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Final Penn Alcohol Craving Scale (PACS) Score
Description
Craving for alcohol will be assessed using the Penn Alcohol Craving Scale (PACS) The PACS is a five-item self-administered instrument for assessing craving. Frequency, intensity, and duration of thoughts about drinking are assessed along with ability to resist drinking. The final item asks the responder to provide an average rating of his/her craving over the course of the past week. The questions on the PACS use descriptors coupled with numerical ratings ranging from 0 to 6 with the highest possible total score of 30. Higher scores reflect a higher level of craving. This outcome measure is the final PACS total score obtained in the trial.
Time Frame
12 weeks
Title
Mean Number of Drinks/Binge Drinking Day During Treatment
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Garbutt
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

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An Open Label Trial of Bupropion and Naltrexone for Binge Drinking

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