Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1

Study Overview
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Brief Summary
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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.

Official Title
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Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1

Conditions
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Tobacco Dependence

Intervention / Treatment
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* Drug: Varenicline
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Varenicline<br> | Drug: Varenicline<br>* Standard dosing: 0.5 mg/day on days 1-3, 0.5 mg twice daily (morning, evening) on days 4-7, then 1 mg twice daily to the end of the medication period.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Dosing schedule matched to active comparator: on tablet on days 1-3, one tablet twice daily (morning, evening) on days 4-7, then one tablet twice daily to the end of the medication period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire on Smoking Urges - Brief Form | Average of all items, rated from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate higher levels of smoking urge or craving. | 72 hrs abstinence | 
| Minnesota Nicotine Withdrawal Scale - Negative Affect Scale | Average of responses to the anger, depression, anxiety and difficulty concentrating items, which are rated from 0 (not present) to 4 (severe). | 72 hrs abstinence | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Cigarette Evaluation Questionnaire - Satisfaction Scale | Average of the satisfaction, taste and enjoyment items, which are rated from 1 (not at all) to 7 (extremely) | 72 hrs abstinence | 
| Modified Cigarette Evaluation Questionnaire - Reward Scale | 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) | 72 hrs abstinence | 
| Latency to Smoking Relapse | hours until relapse during a smoking abstinence period, verified with breath carbon monoxide (CO) levels | 1 week |