Varenicline Study
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
Description
This double-blind, randomized placebo-controlled trial evaluated the efficacy and safety of varenicline tartrate for the treatment of alcohol use disorder (AUD).
Study Details
Sponsor: The National Institute on Alcohol Abuse and Alcoholism’s Clinical Investigations Group (NCIG)
NCT #: 01146613
Phase: Phase 2
Treatment Arms: Varenicline tartrate 1mg twice a day and matching placebo
Number of clinical sites: 5
Number of Participants: 200
Duration: 12 weeks
Population: Adults diagnosed with AUD in the past year; 29% women; 35% ethnic minorities
Other Study Details: Double-blind, Take Control (computerized behavioral intervention)
Top-line Results: 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 data set was prepared by NIAAA and FastTrack Drugs and Biologics, (the trials Coordinating Center) and was reviewed by CSR Incorporated.
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
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A completed NCIG 003 - Varenicline Data Access Application
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A completed NIAAA Data Use Agreement, signed by your Authorized Institutional Official and the Principal Investigator