A Randomized, Placebo-Controlled Clinical Trial of Naltrexone in Smoking Cessation
Study Summary
The purpose of the proposed study is to conduct a randomized, double-blind clinical trial to compare 50 mg oral naltrexone vs. placebo in conjunction with standard smoking cessation treatment with nicotine patch (four weeks) and counseling (six sessions). Participants (N=324) will be randomized (assigned by chance) to receive either naltrexone or placebo starting one week prior to the quit date and continue for 12 weeks after the quit date. Although naltrexone is not a proven smoking cessation therapy, the goal of the study is to test if naltrexone may help smokers quit. The smoking status of participants will be evaluated during the pre-quit date period, initial smoking cessation, relapse prevention, and at one year follow-up.
Participation Details
Participants will attend 10 study visits over a 12-week period. Compensation is $230 in the form of cash and gift cards for completing study measures on time. Reimbursement for parking or CTA is also provided.
Inclusion criteria:
- Age 18 to 65, male or female
- Smoke between 15 to 40 cigarettes daily for at least two years
- Relatively healthy, with no medical or psychiatric conditions that would adversely interact with study parameters (see exclusion criteria for specific details)
- Desire to quit smoking
Exclusion criteria:
- Past or current medical disorders (cardiovascular, hepatic, neurological, endocrine, etc.) which may adversely interact with study measures or increase risk of adverse events including symptomatic coronary artery disease or any liver disease
- Uncontrolled blood pressure
- Clinically significant lab test abnormalities (significant renal impairment, abnormal transaminases)
- Currently pregnant, plans to become pregnant, or lack of effective birth control over next three months, and/or currently lactating, or plans for breastfeeding over next three months
- Use of any medication that may adversely interact with study measures or may cause hepatic injury or toxicity
- Unwillingness to attend smoking cessation treatment sessions, take the nicotine patch, or be randomized into medication or placebo conditions, or be available for follow-up assessments
Study Director: Andrea C. King, PhD
Department: Psychiatry
For more information, contact:
Mihai Raicu, MS
5841 S. Maryland Avenue, MC 3077
Chicago, IL 60637
(773) 834-8654
stopsmoking@uchicago.edu
IRB: #13976A
