Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1

Tobacco Dependence Clinical Trial

Official title:

Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03507127
• Other study ID #: R21DA041114
• Status: Terminated
• Phase: Phase 2
• Start date: May 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: April 2022
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia
• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Brown University, 121 South Main Street	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Brief Psychiatric Rating Scale	Sum of all items rated from 1 (not present) to 7 (extremely severe)	72 hrs abstinence
Primary	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
Primary	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	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
Secondary	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
Secondary	Latency to Smoking Relapse	hours until relapse during a smoking abstinence period, verified with breath carbon monoxide (CO) levels	1 week