Tobacco Use Disorder Clinical Trial
Official title:
Phase 4 Study of Treating Schizophrenic Smokers Using Varenicline and Behavioral Intervention: Effects on Craving, Cues and Withdrawal
This is a clinical research protocol to study the efficacy of combined varenicline (Chantix)
and motivational interviewing (MI) for smoking cessation in a sample of smokers who have
been diagnosed with schizophrenia or schizoaffective disorder. The study is a double-blind,
randomized, controlled, subacute treatment trial of MI plus varenicline (VAR-MI) versus MI
plus placebo (PLA-MI). The pharmaceutical treatment will utilize Chantix at a dose of 1
mg/day for a period of two weeks.
The primary goal is to determine if VAR-MI decreases baseline behavioral measures of urge
and withdrawal and reduces baseline rates of cigarette consumption. The primary efficacy
measures of VAR-MI vs. PLA-MI treatment are: Minnesota Nicotine Withdrawal Scale,
Questionnaire for Smoking Urge-brief, number of cigarettes smoked per day in the previous
week, CO levels, and Brief Psychiatric Rating Scale and Positive And Negative Symptom Scale
scores on the last day of the study. Other primary outcome measures are to determine the
effects of VAR-MI and PLA-MI on smoking cue-induced urges in tobacco cue reactivity sessions
and reward responsiveness as assessed by a computerized task.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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