Alcoholism
Conditions
Brief summary
Combine is a multicenter, randomized clinical trial that will evaluate combinations of three interventions for treating alcohol dependence. The goal is to determine whether improvement in treatment outcomes can be achieved by various combinations of drug and behavioral interventions. Two of the interventions will consist of pharmacological treatment with naltrexone (Revia) or acamprosate (Campral). The third intervention is a multicomponent behavioral therapy including such components as motivational enhancement therapy, cognitive behavioral therapy, and referral to self-help groups, including AA. All three interventions will include a component supporting compliance to medications and reduction in drinking.
Interventions
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Lipha Pharmaceuticals
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The following inclusion criteria are to be met: 1. Male and female outpatients \> 18 years of age. 2. Participants will have a current DSM-IV diagnosis of alcohol dependence. 3. Participants will have signed a witnessed informed consent. 4. Participants must have been drinking a minimum of \> 14 drinks (females) or \> 21 drinks (males) on average per week over a consecutive 30-day period in the 90-day period prior to initiation of abstinence, and have two or more days of heavy drinking (defined as 4 drinks for females and 5 drinks for males) in the 90-day period prior to initiation of abstinence. 5. Participants must have had a minimum of 4 consecutive days (96 hours) of abstinence and have a CIWA \< 8 prior to randomization. 6. Participants can be abstinent for a maximum of 21 days prior to randomization. 7. Participants will have no more than 21 consecutive days of planned absence during the 16 week active treatment period. 8. Participants who are able to identify at least one locator person to assist in tracking the participant for follow-up assessment. 9. Participants who are able to speak and understand English.
Exclusion criteria
The following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent days abstinent | — |
| Time to relapse to heavy drinking | — |
Secondary
| Measure | Time frame |
|---|---|
| measures of drinking outcomes ((duration of abstinence, measures of frequency and intensity, et al.) | — |
| psychological assessments | — |
| quality of life | — |
| measures of adverse experiences | — |
Countries
United States
Outcome results
None listed