Data Access Policy, Application and Agreement

COMBINE

A Multisite Trial of Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence

Introduction

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 publications: Anton, R.F., O'Malley, S.S., Ciraulo, D.A., Cisler, R.A., Couper, D., Donovan, D.M., Gastfriend, D.R., Hosking, J.D., Johnson, B.A., LoCastro, J.S., Longabaugh, R., Mason, B.J., Mattson, M.E., Miller, W.R., Pettinati, H.M., Randall, C.L., Swift, R., Weiss, R.D., Williams, L.D. & Zweben, A. Combined pharmacotherapies and behavioral interventions for alcohol dependence: the COMBINE study: a randomized controlled trial. Journal of the American Medical Association 295(17):2003-2017, 2006. Other articles either published, or in press, can be found at the COMBINE Study website as indicated below. Individuals requesting the data set for specific analyses are urged to view the website to better understand what has been previously published.

Data Access Application Procedure and Access Policy

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 this document.

Qualified researchers should complete (1) the attached Data Access Application form and (2) sign the attached Data Access 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.
Associate Director
Division of Treatment and Recovery Research
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2041
Bethesda , Maryland20892-9304
(Rockville, Maryland20852-1705 for Federal Express)
Tel: (301) 443-0636
Fax: (301) 443-8774
Email: rlitten@mail.nih.gov

 

Data Access Application form  |   Data Access Agreement