Human Laboratory Study of Varenicline for Alcohol Use Disorder

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Alcohol Use Disorder

In brief

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.

Key facts

Study ID

NCT03035708

Run by

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

People needed

47

Starts

2017-05-01

Expected to finish

2018-07-07

Last updated by the study team

2019-10-23

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Contact site for additional information

Where it is running

• Yale University School of Medicine — New Haven, Connecticut, United States
• Brown University — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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