Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1

NCT03507127 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: R21DA041114
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Modified Cigarette Evaluation Questionnaire - Satisfaction Scale

  72 hrs abstinence

• Modified Cigarette Evaluation Questionnaire - Reward Scale

  72 hrs abstinence

• Latency to Smoking Relapse

  1 week

Other Outcomes (1)

• Brief Psychiatric Rating Scale

  72 hrs abstinence

Study Arms (2)

Varenicline

ACTIVE COMPARATOR

Drug: Varenicline

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Varenicline 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.

Varenicline

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: gender is based on self-report
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women
• Ages 18-65
• Have schizophrenia or schizoaffective disorder
• Would like to quit smoking within the next 6 months
• Have smoked at least 10 cigarettes per day in the past year
• Have breath CO level \> 10 ppm
• Able to speak, read and comprehend English well enough to complete study procedures

You may not qualify if:

• Pregnant, breast-feeding, or unwilling to use medically-approved contraception
• Currently using varenicline, bupropion or nicotine replacement therapy for smoking cessation
• Medical disease that would preclude participation
• Unstable psychiatric conditions
• Body mass index (BMI) \< 15 or \> 38 kg/m2
• Past-month suicidal intention, with or without a specific plan
• Positive urine drug screen or breath alcohol level \> 0.01% at screening

Sponsors & Collaborators

• Brown University: lead

Study Sites (1)

Brown University, 121 South Main Street

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Limitations and Caveats

Early termination leading to small number of subjects analyzed

Results Point of Contact

• Title: Dr. Jennifer Tidey
• Organization: Brown University

jennifer_tidey@brown.edu

4018636418

Study Officials

• Jennifer Tidey, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 24, 2018
• Study Start: May 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: May 17, 2022
• Results First Posted: May 17, 2022

Record last verified: 2022-04

Locations

US (1)