Description

The COMBINE Study is the largest pharmacotherapy trial conducted for Alcohol Use Disorder in the United States.  This clinical trial evaluated the efficacy of naltrexone and acamprosate, both alone and in combination, in the context of medical management with and without Combined Behavioral Intervention (CBI).   

Study Details

Sponsor: The National Institute on Alcohol Abuse and Alcoholism

NCT #:  00006206

Trial Type:  Phase 3

Treatment Arms:

• CBI, Medical Management, Medication (Acamprosate, Naltrexone, Acamprosate + Naltrexone, or Placebo)
• Medical Management and Medication (Acamprosate, Naltrexone, Acamprosate + Naltrexone, or Placebo)
• CBI Only (No medication or placebo)

Medications: 

• Acamprosate 1000mg 3 times a day and matching placebo
• Naltrexone 100mg once a day or matching placebo

Number of clinical sites: 11

Number of Participants: 1383

Duration: 4 months; follow-ups 1-year post-intervention

Population: Individuals with alcohol dependence; 31% women; 23% ethnic minorities

Other Study Details: Double-blind, Combined Behavioral Intervention (intensive counseling by alcohol treatment specialists)

Top-line Results: All groups showed substantial reduction in drinking.  Patients receiving naltrexone had a higher percent of days abstinent than those receiving medical management only, a significant naltrexone X behavioral intervention interaction (P=.009).  Naltrexone also reduced the risk of a heavy drinking day (hazard ratio, 0.72, 97.5% CI, 0.53-0.98; P=.02n).  Acamprosate showed no signification effect on drinking vs. placebo, either by itself or with any combination of naltrexone, CBI or both. 

Publication

Anton RF, O'Malley SS, Ciraulo DA, Cisler RA, Couper D, Donovan DM, Gastfriend DR, Hosking JD, Johnson BA, LoCastro JS, Longabaugh R, Mason BJ, Mattson ME, Miller WR, Pettinati HM, Randall CL, Swift R, Weiss RD, Williams LD, Zweben A; COMBINE Study Research Group. 2006. Combined pharmacotherapies and behavioral interventions for alcohol dependence: the COMBINE study: a randomized controlled trial. JAMA 295(17):2003-17. PMID:16670409

Dataset Application Procedure 

The COMBINE Study contains individual level data and is categorized as a controlled access data set. Only qualified research investigators who, along with their institutions, have certified their agreement with the expectations and terms of access detailed in the COMBINE Data Access Application and the NIAAA Data Use Agreement will be provided access. 

To apply for access, please send the following to NIAAA-DAC@mail.nih.gov 

1. A completed COMBINE Data Access Application 

2. A completed NIAAA Data Use Agreement, signed by your Authorized Institutional Official and the Principal Investigator 

COMBINE data use agreement      COMBINE data access application