Varenicline for Alcohol Dependence

Alcoholism Clinical Trial

— NCIG 003  

Official title:

A Phase 2, Double Blind, Placebo Controlled Trial to Assess the Efficacy of Varenicline Tartrate for Alcohol Dependence in Very Heavy Drinkers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01146613
• Other study ID #: NIAAA-DTRR-2010-LITTEN-003
• Status: Completed
• Phase: Phase 2
• First received: June 16, 2010
• Last updated: August 20, 2014
• Start date: February 2011
• Est. completion date: July 2012

Study information

• Verified date: August 2014
• Source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to assess the efficacy of varenicline in reducing the proportion of heavy drinking days during the last 8 weeks of treatment in subjects with alcohol dependence confirmed by Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR) criteria and who frequently consume 10 or more drinks per drinking day for men and 8 or more drinks for women (designated as "very heavy" drinkers).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Be at least 18 years of age.

2. Have a current (past 12 months) DSM-IV-TR diagnosis of alcohol dependence.

3. Be seeking treatment for alcohol dependence and desire a reduction or cessation of drinking.

4. 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.

5. 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:

1. oral contraceptives,

2. contraceptive sponge,

3. patch,

4. double barrier (diaphragm/spermicidal or condom/spermicidal),

5. intrauterine contraceptive system,

6. levonorgestrel implant,

7. medroxyprogesterone acetate contraceptive injection,

8. complete abstinence from sexual intercourse,

9. hormonal vaginal contraceptive ring, and/or

6. Be able to take oral medication and be willing to adhere to the medication regimen

7. Complete all assessments required at screening and baseline.

8. Provide evidence of stable residence in the last 2 months prior to randomization, have reasonable transportation arrangements to the study site, and have no plans to move within the next 3 months or unresolved legal problems. Subjects must provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the subject in case of a missed clinic appointment.

9. Be willing to discontinue the use of nicotine replacement therapies prior to randomization and refrain from using nicotine replacement therapies during the course of the study.

10. Have a blood alcohol content (BAC) by breathalyzer equal to 0.000 when s/he signed the informed consent document.

11. Be someone who in the opinion of the investigator would be expected to complete the study protocol.

12. Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may interfere with study participation.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• Varenicline
0.5mg capsules x 2, 2x a day for 12 weeks
• Placebo
identical matched placebo x 2, 2xday, 13 weeks

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	Dartmouth Medical School	Bedford	New Hampshire
United States	Boston Medical Center	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	Dartmouth Medical School	Hanover	New Hampshire
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Virginia	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weekly Percentage of Heavy Drinking Days	Protocol: The primary outcome measure examines the hypothesis that varenicline will decrease the weekly proportion of heavy drinking days during Study Weeks 2 through 13 as compared to placebo.	Weeks 2-13*	No