Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1

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 Overview

• Status: Terminated
• Conditions: Tobacco Dependence
• Intervention / Treatment: Drug: Varenicline; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Brown University, 121 South Main Street

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	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.
Active Comparator: Varenicline	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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Psychiatric Rating Scale	Sum of all items rated from 1 (not present) to 7 (extremely severe)	72 hrs abstinence

Collaborators and Investigators

• Sponsor: Brown University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: April 19, 2018
• First Posted (Actual): April 24, 2018

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: R21DA041114 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No