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Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1

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ClinicalTrials.gov Identifier: NCT03507127
Recruitment Status : Recruiting
First Posted : April 24, 2018
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Jennifer Tidey, Brown University

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 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
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


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.




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)



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507127


Contacts
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Contact: Christine Goodwin, MSc 401-863-6402 Christine_Goodwin@brown.edu

Locations
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United States, Rhode Island
Brown University, 121 South Main Street Recruiting
Providence, Rhode Island, United States, 02912
Contact: Jennifer Tidey, Ph.D.    401-863-6418    Jennifer_Tidey@brown.edu   
Principal Investigator: Jennifer Tidey, Ph.D.         
Sponsors and Collaborators
Brown University
Investigators
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Principal Investigator: Jennifer Tidey, PhD Brown University

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Responsible Party: Jennifer Tidey, Professor, Brown University
ClinicalTrials.gov Identifier: NCT03507127     History of Changes
Other Study ID Numbers: R21DA041114 ( U.S. NIH Grant/Contract )
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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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