Data Access Policy, Application and Agreement
A Multisite Trial of Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence
The COMBINE Study (often times referred to as COMBINE) is the largest pharmacotherapy trial conducted for alcoholism in the United States, recruiting 1383 alcohol dependent patients, 31% women and 23% ethnic minorities, from 11 sites. This double-blind, randomized placebo-controlled 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). CBI is a therapy that integrates aspects of cognitive behavioral therapy, motivational interviewing and 12-step facilitation. The duration of treatment was four months with follow-ups for one year post treatment. There were nine groups including a CBI only group with no pills and no medical management.
A more detailed overview of the study and main results can be found in the primary 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
Because COMBINE Study contains individual level data, it is categorized as a controlled access data set. Access will only be provided to 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.
Qualified researchers should email the following to NIAAA-DAC@mail.nih.gov
- A completed COMBINE Data Access Application
- A completed NIAAA Data Use Agreement, signed by your Authorized Institutional Official and the Principal Investigator
- Letter of approval or exemption from human subjects research from your IRB of record
Data Use Agreement COMBINE Data Access Application
NIAAA Medications Development Program
Last reviewed: November 2021