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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
5
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.
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.
Brown University, 121 South Main Street
Providence, Rhode Island, United States
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.
Time frame: 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).
Time frame: 72 hrs abstinence
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)
Time frame: 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)
Time frame: 72 hrs abstinence
Latency to Smoking Relapse
hours until relapse during a smoking abstinence period, verified with breath carbon monoxide (CO) levels
Time frame: 1 week
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