Human Laboratory Study of Varenicline for Alcohol Use Disorder
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|ClinicalTrials.gov Identifier: NCT03035708|
Recruitment Status : Completed
First Posted : January 30, 2017
Results First Posted : October 23, 2019
Last Update Posted : October 23, 2019
|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).
|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 outcome is cue-elicited alcohol craving, operationalized as the difference in Visual Analog Scale (VAS) craving for alcohol when exposed to an alcohol cue minus the VAS craving for alcohol when exposed to a water cue. The VAS has a minimum value of 0 and maximum value of 20; higher scores indicate more craving (a worse outcome).
- Percent Heavy Drinking Days [ Time Frame: Weeks 3-6 ]The percentage of heavy drinking days during the last month of treatment (weeks 3-6). A heavy drinking day is defined as 4 or more drinks on a single day for females and 5 or more drinks on a single day for males.
- The Percentage of Subjects Abstinent During the Last Month of Treatment (Weeks 3-6). [ Time Frame: Weeks 3-6 ]The percentage of subjects abstinent from alcohol during the last month of treatment (weeks 3-6).
- Cigarettes Smoked Per Week [ Time Frame: Weeks 3-6 ]The number of cigarettes smoked per week during the last month of treatment (weeks 3-6) computed only among participants who were smokers at baseline (varenicline n=11; placebo n=11). Note: cigarettes smoked per week outcome data was missing for two of the varenicline participants resulting in n=9 available for analysis.
- Penn Alcohol Craving Scale [ Time Frame: Study Weeks 3, 4, 5, 6 (assessed weekly during this period) ]Penn Alcohol Craving Scale (higher numbers are indicative of more craving for alcohol); min = 0, max = 30. The measure was assessed at Study Weeks 3, 4, 5, and 6. The reported outcome is the adjusted mean total score across weeks 3-6.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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)|