Naltrexone combined with either cognitive behavioral or motivational enhancement therapy for alcohol dependence.
Raymond F Anton, Darlene H Moak, Patricia Latham...
https://pubmed.ncbi.nlm.nih.gov/16012278Completed
Phase 4
Age: 21Years - 70Years
All Genders
ID00000456
Comparison of Cognitive Behavioral Therapy and Motivational Enhancement Therapy Plus Naltrexone for Alcoholism
Led by Medical University of South Carolina · Updated on 2010-10-04
160
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Medical University of South Carolina
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will compare cognitive behavioral therapy with a time-limited motivational enhancement therapy to which naltrexone (Revia) or placebo medication is added. In this randomized clinical trial, 160 alcohol-dependent outpatients, after 5 days of abstinence, will receive one of the two psychosocial therapies and either naltrexone (Revia) or placebo for a 12-week treatment period. Abstinence rates, alcohol use, and time to alcohol relapse will be evaluated in all four groups along with measures of alcohol craving, biological measures of alcohol consumption, drinking consequences, changes in self-confidence for avoiding alcohol, and medication compliance. All study participants will be assessed for measures of outcome variables at 3 and 6 months after completing the treatment protocol.
CONDITIONS
Official Title
Behavioral Therapy Plus Naltrexone for Alcoholism
Who Can Participate
Age: 21Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Meets criteria for alcohol dependence, has not had more than one previous inpatient medical detoxification.
- Consumes on average five standard drinks per day.
- Able to maintain sobriety for five days (with or without the aid of detoxification medications) as determined by self-report, collateral report, and breathalyzer measurements.
- Able to read and understand questionnaires and informed consent.
- Lives within 50 miles of the study site.
You will not qualify if you...
- Currently meets criteria for any other psychoactive substance dependency disorder.
- Ever abused opiates.
- Used psychoactive substance abuse, except marijuana, within the last 30 days as evidenced by patient report, collateral report, and urine drug screen.
- Meets criteria for disorders of major depression, panic disorder, obsessive-compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, schizophrenia, or any other psychotic disorder or organic mental disorder.
- Meets criteria for dissociate disorder or eating disorders.
- Has current suicidal or homicidal ideation.
- Need for maintenance or acute treatment with any psychoactive medication including antiseizure medications.
- Current use of disulfiram (Antabuse).
- Clinically significant medical problems that would impair participation or limit medication ingestion.
- Hepatocellular disease.
- Sexually active females of child bearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.
- Have current charges pending for a violent crime.
- Does not have a stable living situation and a reliable source of collateral reporting.
- Has taken an opiate antagonist drug in the last month.
Trial Site Locations
Total: 1 location
1
Medical Univ. of South Carolina
Charleston, South Carolina, United States, 29425
Status Unknown
Loading map...
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
0
Similar Trials
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here