Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
216 participants
INTERVENTIONAL
2010-05-31
2016-06-30
Brief Summary
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Detailed Description
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1. Monthly Brief Contact or
2. Extended Non-Specific Behavioral Treatment or
3. Extended Relapse Prevention Treatment or
4. Extended Relapse Prevention Treatment + availability of varenicline treatment.
Each extended treatment protocol is 40 weeks in duration following the initial 12 weeks of treatment.
All participants will be assessed at weeks 12, 24, 52, 64, and 104, on smoking as well as other psychometric measures.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Extended Brief Contact
Following standard brief treatment, participants have monthly meetings with medical staff.
Varenicline
All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Participants in the Extended Relapse Prevention plus varenicline will receive varenicline for up to 40 additional weeks.
Initial Individual counseling
Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.
Check-ins with medical staff
Monthly brief (10-15 minutes) meetings with medical staff.
Extended Health Education
Following standard treatment, participants receive monthly counseling with content based on a health education model.
Varenicline
All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Participants in the Extended Relapse Prevention plus varenicline will receive varenicline for up to 40 additional weeks.
Initial Individual counseling
Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.
Extended Individual Counseling - Health Model
Monthly counseling sessions across a nine month period with content based on a health education model. Each session is 30-45 minutes in duration.
Extended Relapse Prevention plus varenicline
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline.
Varenicline
All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Participants in the Extended Relapse Prevention plus varenicline will receive varenicline for up to 40 additional weeks.
Initial Individual counseling
Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.
Extended Individual Counseling - Relapse Prevention Model
Eleven individual counseling sessions across a nine month period with content based on a relapse prevention model. Each session is 30-45 minutes in duration.
Extended Relapse Prevention
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.
Varenicline
All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Participants in the Extended Relapse Prevention plus varenicline will receive varenicline for up to 40 additional weeks.
Initial Individual counseling
Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.
Extended Individual Counseling - Relapse Prevention Model
Eleven individual counseling sessions across a nine month period with content based on a relapse prevention model. Each session is 30-45 minutes in duration.
Interventions
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Varenicline
All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Participants in the Extended Relapse Prevention plus varenicline will receive varenicline for up to 40 additional weeks.
Initial Individual counseling
Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.
Check-ins with medical staff
Monthly brief (10-15 minutes) meetings with medical staff.
Extended Individual Counseling - Health Model
Monthly counseling sessions across a nine month period with content based on a health education model. Each session is 30-45 minutes in duration.
Extended Individual Counseling - Relapse Prevention Model
Eleven individual counseling sessions across a nine month period with content based on a relapse prevention model. Each session is 30-45 minutes in duration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be smoking 5 or more cigarettes per day
Exclusion Criteria
* Current diagnosis of schizophrenia
* Acute life threatening diseases
* Evidence of alcohol or other drug abuse so severe that the patient is judged to be potentially unable to comply with the protocol
* Pregnancy or lactation
* Individuals with out of normal range blood pressure, active angina, valve disease, valve replacement, active cardiomyopathies, myocardial infarction or Coronary artery bypass grafting (CABG) within one year, and Congestive heart failure (CHF)
18 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Pfizer
INDUSTRY
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Gary Humfleet, Ph. D.
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California San Francisco
San Francisco, California, United States
Countries
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References
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Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
Other Identifiers
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11633
Identifier Type: OTHER
Identifier Source: secondary_id
DA002538
Identifier Type: -
Identifier Source: org_study_id