Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1

• ClinicalTrials.gov Identifier: NCT03507127
• Recruitment Status: Terminated
• First Posted: April 24, 2018
• Last Update Posted: August 21, 2020
• Sponsor: Brown University
• Information provided by (Responsible Party): Jennifer Tidey, Brown University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Tobacco Dependence	Drug: Varenicline; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1
• Actual Study Start Date: May 1, 2018
• Actual Primary Completion Date: June 30, 2019
• Actual Study Completion Date: June 30, 2019

Arms and Interventions

Arm	Intervention/treatment
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.
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.

Outcome Measures

Primary Outcome Measures :

1. Questionnaire on Smoking Urges - Brief form [ Time Frame: 72 hrs abstinence ]
   Average of all items, rated from 1 (strongly disagree) to 7 (strongly agree)
2. Minnesota Nicotine Withdrawal Scale - Negative Affect Scale [ Time Frame: 72 hrs abstinence ]
   Average of responses to the anger, depression, anxiety and difficulty concentrating items, which are rated from 0 (not present) to 4 (severe).

Secondary Outcome Measures :

1. Modified Cigarette Evaluation Questionnaire - Satisfaction scale [ Time Frame: 72 hrs abstinence ]
   Average of the satisfaction, taste and enjoyment items, which are rated from 1 (not at all) to 7 (extremely)
2. Modified Cigarette Evaluation Questionnaire - Reward scale [ Time Frame: 72 hrs abstinence ]
   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)
3. Latency to smoking relapse [ Time Frame: 1 week ]
   hours until relapse during a smoking abstinence period, verified with breath carbon monoxide (CO) levels

Other Outcome Measures:

1. Brief Psychiatric Rating Scale [ Time Frame: 72 hrs abstinence ]
   Sum of all items rated from 1 (not present) to 7 (extremely severe)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: gender is based on self-report
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Rhode Island

Brown University, 121 South Main Street

Providence, Rhode Island, United States, 02912

Sponsors and Collaborators

Brown University

Investigators

• Principal Investigator: Jennifer Tidey, PhD; Brown University

More Information

• Responsible Party: Jennifer Tidey, Professor, Brown University
• ClinicalTrials.gov Identifier: NCT03507127
• Other Study ID Numbers: R21DA041114 ( U.S. NIH Grant/Contract )
• First Posted: April 24, 2018
• Last Update Posted: August 21, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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

Additional relevant MeSH terms:

Tobacco Use Disorder; Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Varenicline; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs