NIAAA Protocol NCIG 003: A Phase 2, Double-Blind, Placebo Controlled Trial to Assess the Efficacy of Varenicline Tartrate for Alcohol Dependence

Study Details

This double-blind, randomized placebo-controlled trial evaluated the efficacy and safety of varenicline tartrate for the treatment of alcohol use disorder (AUD). 

• 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

How to Access Varenicline Study Data

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.

To apply for access, please send 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