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
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
Dataset 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 qualified research investigators who, along with their institutions, have certified their agreement with the expectations and terms of access detailed in the Varenicline Data Access Application and the NIAAA Data Use Agreement.
Qualified researchers should email the following to NIAAA-DAC@mail.nih.gov
- A completed NCIG 003 - Varenicline 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
Last reviewed: November 2021