Alcohol Abuse Clinical Trial
Official title:
Efficacy and Safety of the Melanocortin Activator Bupropion in Treating Binge Drinking
Verified date | August 2020 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
.
Status | Completed |
Enrollment | 42 |
Est. completion date | September 17, 2019 |
Est. primary completion date | August 19, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 44 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Change in GGT | Change in serum Gamma-glutamyltransferase (GGT) levels | Randomization (Week 0) to Week 12 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03165942 -
Neuroendocrine Response to Oral Alcohol Administration
|
Phase 1 | |
Recruiting |
NCT05343039 -
Technology Enhanced Adolescent Mental Health (TEAM)
|
N/A | |
Active, not recruiting |
NCT04070521 -
EEG Monitoring in the Emergency Department
|
||
Recruiting |
NCT05246202 -
Personalized Feedback Intervention for Latinx Drinkers With Anxiety
|
N/A | |
Completed |
NCT05036499 -
PFI for Pain-Related Anxiety Among Hazardous Drinkers With Chronic Pain
|
N/A | |
Recruiting |
NCT04368416 -
Anxiety/Depression, Sleep and Alcohol in Elderly Anxiety/Depression, Sleep Disturbances and Alcohol Use Disorder in Elderly With Cognitive Complaints
|
||
Not yet recruiting |
NCT04557631 -
Evaluation of the Threshold for the Interpretation of the Results of a Method for the Blood Determination of Phosphatidyléthanol
|
||
Terminated |
NCT00890149 -
Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults
|
Phase 2 | |
Completed |
NCT02681406 -
Smartphone Based Continuing Care for Alcohol
|
N/A | |
Completed |
NCT02179749 -
Mifepristone Treatment of Alcohol Use Disorder
|
Phase 2 | |
Completed |
NCT02448134 -
A Community-Based Strategy for Preventing Underage Drinking
|
N/A | |
Withdrawn |
NCT01847300 -
cSBI-M for Young Military Personnel
|
N/A | |
Withdrawn |
NCT01796158 -
Pilot Test of Computerized MET to Reduce Adolescent Alcohol Use
|
N/A | |
Withdrawn |
NCT01511679 -
Brain-imaging and Adolescent Neuroscience Consortium
|
N/A | |
Completed |
NCT01553136 -
Varenicline Treatment of Alcohol Dependence in Smokers
|
Phase 2 | |
Terminated |
NCT01408641 -
Topiramate for Alcohol Use in Posttraumatic Stress Disorder
|
N/A | |
Withdrawn |
NCT01275391 -
cSBIRT to Reduce Teen Tobacco, Alcohol and Drug Use
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT01539525 -
Screening to Augment Referral to Treatment- Project START
|
Phase 2 | |
Completed |
NCT01207258 -
Brief Intervention for Problem Drinking and Partner Violence
|
Phase 2 | |
Completed |
NCT00907309 -
Dental and Medical Office iMET to Reduce Teen Tobacco, Alcohol, and Drug Use
|
Phase 1/Phase 2 |