At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 47 enrolled
Drug / intervention
Varenicline +1 moredrug
Likely dose
Varenicline 1 mg orally twice daily (BID)AI-extracted
Key inclusion· 8
- ✓Age ≥21 years
- ✓DSM-5 criteria for alcohol use disorder of at least moderate severity
- ✓Actively seeking treatment for AUD with desire to reduce or stop drinking
- ✓Able to understand consent, follow instructions in English, and complete study questionnaires
Key exclusion· 1
- ✕Detailed exclusion criteria not fully specified in published record
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Human Laboratory Study of Varenicline for Alcohol Use Disorder
National Institute on Alcohol Abuse and Alcoholism (NIAAA)·interventional·Posted Jan 30, 2017·Updated Oct 23, 2019
In Brief
A Phase 2 clinical trial evaluating Varenicline and Placebo oral capsule for Alcohol Use Disorder. Completed, enrolled 47 participants across 2 sites.
Detailed Summary
This study is a double-blind, randomized, placebo-controlled, parallel group, two-site study designed to assess the effects of varenicline as compared with placebo on responses to in vivo alcohol cue exposure in the human laboratory setting.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Use Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 2017
Enrollment StartMay 2017
Primary CompletionJul 2018
Study CompletionJul 2018
TodayJul 2026
First PostedJan 30, 2017
Enrollment StartMay 1, 2017
Primary CompletionJul 1, 2018
Study CompletionJul 7, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.4 years ago
Interventions
Vareniclinedrug
1 mg BID
Placebo oral capsuledrug
1 mg BID