- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01162239
Maintaining Nonsmoking
Study Overview
Status
Conditions
Detailed Description
This study will test a series of hypotheses comparing the efficacy of the relapse prevention treatment to other extended treatments. All participants will be assessed at baseline on demographics, smoking behaviors, nicotine dependence, depression, alcohol and other drug history and problems, mood disturbance, treatment support, stress, health status, and motivation for change. Participants will be randomly assigned to one of four treatment conditions. All participants will receive 12 weeks of combined pharmacological treatment (varenicline) and behavioral treatment (five individual counseling sessions). Following this brief treatment, participants will be randomly assigned to one of four treatment protocols
- Monthly Brief Contact or
- Extended Non-Specific Behavioral Treatment or
- Extended Relapse Prevention Treatment or
- 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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- University of California San Francisco
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- At least 18 years of age
- Must be smoking 5 or more cigarettes per day
Exclusion Criteria:
- Previous history of bipolar/manic-depressive disorder
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Extended Brief Contact
Following standard brief treatment, participants have monthly meetings with medical staff.
|
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.
Other Names:
Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.
Monthly brief (10-15 minutes) meetings with medical staff.
|
Experimental: Extended Health Education
Following standard treatment, participants receive monthly counseling with content based on a health education model.
|
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.
Other Names:
Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.
Monthly counseling sessions across a nine month period with content based on a health education model.
Each session is 30-45 minutes in duration.
|
Experimental: 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.
|
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.
Other Names:
Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.
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.
|
Experimental: Extended Relapse Prevention
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.
|
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.
Other Names:
Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12
Time Frame: 12 weeks following treatment initiation
|
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 parts per million (ppm)) self-reported abstinence from smoking cigarettes in the past 7 days.
Smoking status was then categorized as either Abstinent or Not Abstinent.
|
12 weeks following treatment initiation
|
Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24
Time Frame: 24 weeks following treatment initiation
|
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days.
Smoking status was then categorized as either Abstinent or Not Abstinent.
|
24 weeks following treatment initiation
|
Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52
Time Frame: 52 weeks following treatment initiation
|
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days.
Smoking status was then categorized as either Abstinent or Not Abstinent.
|
52 weeks following treatment initiation
|
Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64
Time Frame: 64 weeks following treatment initiation
|
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days.
Smoking status was then categorized as either Abstinent or Not Abstinent.
|
64 weeks following treatment initiation
|
Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104
Time Frame: 104 weeks following treatment initiation
|
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days.
Smoking status was then categorized as either Abstinent or Not Abstinent.
|
104 weeks following treatment initiation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of Combined Extended vs Brief Treatment at Week 24
Time Frame: 24 weeks following treatment initiation
|
The three extended treatment programs were combined and compared to the Brief treatment, with extended treatments expected to produce significant higher CO corrected abstinence rates overall.
Comparisons will be tested using Chi-Square analysis.
|
24 weeks following treatment initiation
|
Comparison of Combined Extended vs Brief Treatment at Week 52
Time Frame: 52 weeks following treatment initiation
|
The three extended treatment programs were combined and compared to the Brief treatment, with extended treatments expected to produce significant higher CO corrected abstinence rates overall.
Comparisons will be tested using Chi-Square analysis.
|
52 weeks following treatment initiation
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gary Humfleet, Ph. D., University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DA002538
- 2R01DA002538 (U.S. NIH Grant/Contract)
- 11633 (Other Identifier: University of California, San Francisco)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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