Behavioral Therapy Plus Naltrexone for Alcoholism
Information source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information obtained from ClinicalTrials.gov on October 19, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcoholism; Alcohol Dependence
Intervention: naltrexone (Revia) (Drug); cognitive behavior therapy (Behavioral); motivational enhancement therapy (Behavioral)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Official(s) and/or principal investigator(s):
Ray Anton, MD, Principal Investigator, Affiliation: Medical University of South Carolina
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.
Comparison of Cognitive Behavioral Therapy and Motivational Enhancement Therapy Plus Naltrexone for Alcoholism
Study design: Interventional, Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Minimum age: 21 Years.
Maximum age: 70 Years.
- 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.
- 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.
Locations and Contacts
Medical Univ. of South Carolina, Charleston, South Carolina 29425, United States
Ending date: September 2002
Last updated: January 24, 2007