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Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1

Brown University logo

Brown University

Status and phase

Terminated
Phase 2

Conditions

Tobacco Dependence

Treatments

Drug: Varenicline
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03507127
R21DA041114

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

5 participants in 2 patient groups, including a placebo group

Varenicline
Active Comparator group
Treatment:
Drug: Varenicline
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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