Human Laboratory Study of Varenicline for Alcohol Use Disorder
|ClinicalTrials.gov Identifier: NCT03035708|
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : October 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use Disorder||Drug: Varenicline Drug: Placebo oral capsule||Phase 1 Phase 2|
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. After signing informed consent, subjects will be screened for eligibility including medical history, physical examination, vital signs, electrocardiogram (ECG), drinking history by the timeline follow-back (TLFB) method, alcohol breathalyzer test, Clinical Institute Withdrawal Assessment for Alcohol-revised (CIWA), medication use, MINI neuropsychiatric interview, urine toxicology screen, clinical chemistry, response to cue reactivity, and Columbia Suicide Severity Rating Scale (CSSR-S). Women of child-bearting potential will have a pregnancy test. If eligible for the study, subjects will be randomized using a stratified permuted block randomization procedure in an approximate 1:1 ratio (targeting 24 subjects per group - 12 subjects per group per site) to receive either varenicline or placebo for 6 weeks. Any nicotine use versus no use (cigarettes, cigars, chewing tobacco, electronic cigarettes, etc.) in the week before randomization is the stratification variable.
Varenicline or matched placebo will be titrated over the first week of the study up the maintenance dose of 1 mg (active) or two capsules (placebo) taken orally BID for an additional 5 weeks. Subjects will be seen in the clinic at screening, at randomization and 6 other times during the study. A final follow-up telephone interview will occur during Week 9 (2 weeks after the end of study visit).
After the first two weeks and after five weeks of investigational product administration at Study Week 3 and Study Week 6, respectively, subjects will undergo a cue reactivity paradigm session (HLAB) including 4 individual visual analog scale (VAS) items assessing alcohol craving, 2 VAS items assessing emotional reactivity to picture stimuli, and 2 items assessing emotional manipulation. Immediately after the HLAB session, subjects will view each picture again and record the emotion felt using the Self-Manikin Assessment (SAM). Other assessments at baseline (prior to the first dose of investigational product) and/or during the maintenance period include clinical chemistry, mood/behavior/thinking questions, blood for medication compliance, vital signs, ECG, concomitant medications, CIWA-AR, pregnancy test and birth control methods, drinking goal, adverse events (AEs), Alcohol Craving Questionnaire - Short Form (ACQ-SF-R), Penn Alcohol Craving Scale (PACS), Fagerström Test for Nicotine Dependence, smoking quantity/frequency, Pittsburg Sleep Quality Index (PSQI), and Profile Of Moods State (POMS).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Human Laboratory Study of Varenicline for Alcohol Use Disorder|
|Actual Study Start Date :||May 1, 2017|
|Actual Primary Completion Date :||July 1, 2018|
|Actual Study Completion Date :||July 7, 2018|
1 mg BID (2 capsules BID)
1 mg BID
Other Name: Chantix
Placebo Comparator: Placebo
1 mg BID (2 capsules BID)
Drug: Placebo oral capsule
1 mg BID
- Cue-elicited craving [ Time Frame: Study Week 3 ]The primary objective of this study is to evaluate the effect of varenicline 1 mg twice-daily (BID), compared with matched placebo, on alcohol cue-elicited alcohol craving during a human laboratory paradigm after two weeks of BID daily dosing among subjects with moderate alcohol use disorder (AUD) as confirmed by the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5™).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035708
|United States, Connecticut|
|Yale University School of Medicine|
|New Haven, Connecticut, United States, 06511|
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02912|
|Study Director:||Raye Litten, PhD||National Institute on Alcohol Abuse and Alcoholism (NIAAA)|