Data Access Policy, Application and Agreement

NIAAA Protocol NCIG 003:

A Phase 2, Double-Blind, Placebo Controlled Trial to Assess the Efficacy of Varenicline Tartrate for Alcohol Dependence

Introduction

This double-blind, randomized placebo-controlled trial evaluated the efficacy and safety of varenicline tartrate, recruiting 200 alcohol-dependent patients from 5 sites. All subjects received either varenicline tartrate or placebo and the Take Control computerized behavioral platform. Patients were stratified on clinical site and regular smoking (10+ cigarettes smoked per day). Across the study maintenance phase (weeks 2-13), the varenicline group had significantly lower weekly percent heavy drinking days (primary outcome) (adjusted mean difference = 10.4), drinks per day, drinks per drinking day, percent very heavy drinking days, alcohol craving, and cigarettes smoker per day, compared with the placebo group (P < 0.05). Varenicline was well-tolerated; adverse events were expected and mild. Three adverse events occurred at statistically greater rates in the varenicline group that the placebo group: nausea (37.1% vs 17.8%, respectively); abnormal dreams (27.8% vs 11.9%, respectively); and constipation (9.3% vs 2.0%, respectively).

The study sponsor was the National Institute on Alcohol Abuse and Alcoholism’s (NIAAA) Clinical Investigations Group (NCIG). The data set was prepared by NIAAA and FastTrack Drugs and Biologics (the trial’s Coordinating Center) and was reviewed by CSR Incorporated. 

A more detailed overview of the study and main results can be found in the primary publication:

Litten RZ, Ryan ML, Fertig JB, Falk DE, Johnson B, Dunn KE, Green AI, Pettinati HM, Ciraulo DA, Sarid-Segal O, Kampman K, Brunette MF, Strain EC, Tiouririne NA, Ransom J, Scott C, Stout R; NCIG (National Institute on Alcohol Abuse and Alcoholism Clinical Investigations Group) Study Group. 2013. A double-blind, placebo-controlled trial assessing the efficacy of varenicline tartrate for alcohol dependence. J Addict Med 7(4):277-86.  PMID: 23728065

Database Application Procedure

Because the Varenicline Study 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 (1) the attached Data Access Application form and (2) 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 Medication Development
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2041
Bethesda, Maryland 20892-9304
(Rockville, Maryland 20852-1705 for Federal Express)
Tel: (301) 443-0636
Fax: (301) 443-8774
Email: rlitten@mail.nih.gov

Data Access Application form  |  Data Transfer Agreement