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

Database Application Procedure

Because COMBINE contains individual level data, it is categorized as a controlled access data set.  Access will only be provided to research investigators who, along with their institutions, have certified their agreement with the expectations and terms of access detailed in the application documents below.

Qualified researchers should complete and sign the attached Data Transfer Agreement. This agreement is designed to protect the integrity of the data set and assure client confidentiality.  Note that the signature and concurrence of your authorized institutional official is also required.  This is ordinarily the person who signs grant applications. Completed applications may be submitted by e-mail, fax, or mail to:

Raye Z. Litten, Ph.D.
Acting Director
Division of Medications Development
National Institute on Alcohol Abuse and Alcoholism
6700B Rockledge Drive
Room 1320
Bethesda, MD 20892-6902
(Bethesda, Maryland 20817-6902 for Federal Express)
Phone: 301-443-0636
Fax: (301) 443-8774


Data Transfer Agreement


NIAAA Medications Development Program


Last reviewed: November 2019