Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1

Phase 2

Terminated

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.

Recruitment & Eligibility

Inclusion Criteria

Men and women
Ages 18-65
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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Varenicline	Varenicline	-

Primary Outcome Measures

Name	Time	Method
Questionnaire on Smoking Urges - Brief Form	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	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 Outcome Measures

Name	Time	Method
Modified Cigarette Evaluation Questionnaire - Reward Scale	72 hrs abstinence	Average of the calm, feel more awake, less irritable, help to concentrate and reduce hunger items, which are rated from 1 (not at all) to 7 (extremely)
Latency to Smoking Relapse	1 week	hours until relapse during a smoking abstinence period, verified with breath carbon monoxide (CO) levels
Modified Cigarette Evaluation Questionnaire - Satisfaction Scale	72 hrs abstinence	Average of the satisfaction, taste and enjoyment items, which are rated from 1 (not at all) to 7 (extremely)