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The study investigators will enroll 45 treatment seeking, cigarette smokers with a Diagnostic and Statistical Manual (DSM-IV) diagnosis of schizophrenia who will be randomly assigned into three arms of treatment for smoking cessation treatment, receiving either 1. Control: "standard therapy" (n=15), including stepwise monotherapy of nicotine patch or bupropion sustained release, 2. Extended treatment with combination bupropion, nicotine patch, and nicotine lozenge for 6 months (n=15), or 3. Extended treatment with combination bupropion, nicotine patch, and nicotine lozenge for 6 months with home visits (n=15) and phone calls to the home or living facility. During all treatments, participants will receive weekly smoking cessation group counseling, as is standard for smoking cessation treatment. At the time of enrollment, participants will complete a one-study visit lead-in to complete baseline assessments, psychological and medical evaluation, and comprehensive assessment of drug use to determine study eligibility. Once determined to be eligible for the trial, participants will be randomly assigned to one of the treatment arms using a randomization procedure. The "standard therapy" treatment arm, or control group, will receive either nicotine patch taper starting at 21 milligrams (mg) daily, nicotine lozenge as needed, and/or bupropion sustained release at 150mg daily for 3 days, then 150 mg twice a day for a total of 12 weeks. The extended therapy arm will start the nicotine patch at 21mg daily with as needed nicotine lozenge for breakthrough cravings and initiation of bupropion sustained release at 150mg daily for 3 days a week prior to starting nicotine replacement, then 150 mg twice daily for 6 months (as tolerated). The third arm will be identical to the second arm except for the added home visit intervention.
Age
21 - No limit years
Sex
ALL
Healthy Volunteers
Yes
West Los Angeles Veterans Affairs Medical Center
Los Angeles, California, United States
Start Date
January 1, 2014
Primary Completion Date
June 1, 2016
Completion Date
June 1, 2016
Last Updated
July 30, 2019
42
ACTUAL participants
Combination Bupropion + NRTs
DRUG
Extended Treatment
OTHER
Home Visits & Calls
OTHER
Monotherapy
DRUG
Lead Sponsor
Brentwood Biomedical Research Institute
NCT07455929
NCT06740383
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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