Nicotine Receptor Density & Response to Nicotine Patch: Pt 2 Extended Treatment
Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
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.