Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1

NCT ID: NCT03507127

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2019-06-30

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.

Conditions

Tobacco Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Varenicline

Group Type: ACTIVE_COMPARATOR

Varenicline

Intervention Type: DRUG

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.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

Varenicline

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Tidey

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Tidey, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

Brown University, 121 South Main Street

Providence, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R21DA041114

Identifier Type: NIH

Identifier Source: org_study_id

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