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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

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:

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.

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

NCT ID

NCT02842073

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

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

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

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

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

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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