Phase 2
Completed N=47
Human Laboratory Study of Varenicline for Alcohol Use Disorder
Source: ClinicalTrials.gov NCT03035708 ↗Enrolled (actual)
47
Serious AEs
2.1%
Results posted
Oct 2019
Primary outcomePrimary: Cue-elicited Craving — 2.1; 2.2 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cue-elicited Craving |
2.1; 2.2 | — |
| SECONDARY Percent Heavy Drinking Days |
30.7; 21.0 | — |
| SECONDARY The Percentage of Subjects Abstinent During the Last Month of Treatment (Weeks 3-6). |
2; 4 | — |
| SECONDARY Cigarettes Smoked Per Week |
47.0; 64.0 | — |
| SECONDARY Penn Alcohol Craving Scale |
10.8; 10.9 | — |
Eligibility Criteria
Inclusion Criteria
To be eligible, the subject must:
- Be at least 21 years of age.
- Meet the DSM 5 criteria for alcohol use disorder of a least moderate severity (AUD-MS).
- Be seeking treatment for AUD and desire a reduction or cessation of drinking.
- Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
- Agree (if the subject is female and of child bearing potential) to use at least one of the following methods of birth control, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal:
- oral contraceptives,
- contraceptive sponge,
- patch,
- double barrier (diaphragm/spermicidal or condom/spermicidal),
- intrauterine contraceptive system,
- levonorgestrel implant,
- medroxyprogesterone acetate contraceptive injection,
- complete abstinence from sexual intercourse, and/or
- hormonal vaginal contraceptive ring.
- Be able to take oral medication and be willing to adhere to the medication regimen.
- Complete all assessments required at screening and baseline.
- Have a place to live in the 2 weeks prior to randomization and not be at risk that s/he will lose his/her housing in the next 2 months.
- Not anticipate any significant problems with transportation arrangements or available time to travel to the study site over the next 2 months.
- Not have any unresolved legal problems that could jeopardize continuation or completion of the study.
- And others.
Exclusion Criteria
- Contact site for additional information
Data sourced from ClinicalTrials.gov (NCT03035708). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.