Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1
Overview
- Phase
- Phase 2
- Intervention
- Varenicline
- Conditions
- Tobacco Dependence
- Sponsor
- Brown University
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Questionnaire on Smoking Urges - Brief Form
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
Schizophrenia is associated with high rates of cigarette smoking and associated morbidity and mortality. In this study, smokers with schizophrenia will complete a baseline session and then randomized to varenicline (VAR) or placebo (PLA). After 1 week on medication, participants will complete a cigarette rating task session. Participants will then undergo a 72-hr abstinence period in which they will come to the laboratory twice per day and receive high-value cash reinforcement contingent upon meeting a strict breath CO abstinence criterion. At each visit, they will rate withdrawal symptoms, mood and craving. At the end of the abstinence period, they will repeat the cigarette rating task. Participants will return to the lab to provide a CO sample 24 hours later, and will text the lab with videos of their CO samples for one week. Date and time of smoking relapse will be measured from these samples.
Investigators
Jennifer Tidey
Professor
Brown University
Eligibility Criteria
Inclusion Criteria
- •Men and women
- •Have schizophrenia or schizoaffective disorder
- •Would like to quit smoking within the next 6 months
- •Have smoked at least 10 cigarettes per day in the past year
- •Have breath CO level \> 10 ppm
- •Able to speak, read and comprehend English well enough to complete study procedures
Exclusion Criteria
- •Pregnant, breast-feeding, or unwilling to use medically-approved contraception
- •Currently using varenicline, bupropion or nicotine replacement therapy for smoking cessation
- •Medical disease that would preclude participation
- •Unstable psychiatric conditions
- •Body mass index (BMI) \< 15 or \> 38 kg/m2
- •Past-month suicidal intention, with or without a specific plan
- •Positive urine drug screen or breath alcohol level \> 0.01% at screening
Arms & Interventions
Varenicline
Intervention: Varenicline
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Questionnaire on Smoking Urges - Brief Form
Time Frame: 72 hrs abstinence
Average of all items, rated from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate higher levels of smoking urge or craving.
Minnesota Nicotine Withdrawal Scale - Negative Affect Scale
Time Frame: 72 hrs abstinence
Average of responses to the anger, depression, anxiety and difficulty concentrating items, which are rated from 0 (not present) to 4 (severe).
Secondary Outcomes
- Modified Cigarette Evaluation Questionnaire - Reward Scale(72 hrs abstinence)
- Latency to Smoking Relapse(1 week)
- Modified Cigarette Evaluation Questionnaire - Satisfaction Scale(72 hrs abstinence)