Overview

Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1

Status:
Terminated
Trial end date:
2019-06-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Brown University
Treatments:
Varenicline
Criteria
Inclusion Criteria:

1. Men and women

2. Ages 18-65

3. Have schizophrenia or schizoaffective disorder

4. Would like to quit smoking within the next 6 months

5. Have smoked at least 10 cigarettes per day in the past year

6. Have breath CO level > 10 ppm

7. Able to speak, read and comprehend English well enough to complete study procedures

Exclusion Criteria:

1. Pregnant, breast-feeding, or unwilling to use medically-approved contraception

2. Currently using varenicline, bupropion or nicotine replacement therapy for smoking
cessation

3. Medical disease that would preclude participation

4. Unstable psychiatric conditions

5. Body mass index (BMI) < 15 or > 38 kg/m2

6. Past-month suicidal intention, with or without a specific plan

7. Positive urine drug screen or breath alcohol level > 0.01% at screening