Maintaining Nonsmoking
3 other identifiers
interventional
216
1 country
1
Brief Summary
The research is based on a chronic disorder model of cigarette smoking which suggests that long-term treatment targeted to prevent relapse may be useful. Based on this model, the investigators have developed a relapse prevention treatment to intervene on five areas important in relapse prevention, including fluctuating motivation, depression, withdrawal, weight gain, and social support. This treatment protocol has produced high long-term abstinence rates when implemented in a clinical research setting. The current study will evaluate the treatment model when implemented in a medical outpatient setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2010
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 14, 2010
CompletedFirst Posted
Study publicly available on registry
July 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedResults Posted
Study results publicly available
November 12, 2020
CompletedNovember 12, 2020
October 1, 2020
6.1 years
June 14, 2010
October 19, 2020
October 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12
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
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
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
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
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 Outcomes (2)
Comparison of Combined Extended vs Brief Treatment at Week 24
24 weeks following treatment initiation
Comparison of Combined Extended vs Brief Treatment at Week 52
52 weeks following treatment initiation
Study Arms (4)
Extended Brief Contact
EXPERIMENTALFollowing standard brief treatment, participants have monthly meetings with medical staff.
Extended Health Education
EXPERIMENTALFollowing standard treatment, participants receive monthly counseling with content based on a health education model.
Extended Relapse Prevention plus varenicline
EXPERIMENTALFollowing standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline.
Extended Relapse Prevention
EXPERIMENTALFollowing standard treatment, participants receive monthly counseling with content based on a relapse prevention model.
Interventions
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.
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.
Monthly counseling sessions across a nine month period with content based on a health education model. Each session is 30-45 minutes in duration.
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.
Eligibility Criteria
You may qualify if:
- At least 18 years of age
- Must be smoking 5 or more cigarettes per day
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Franciscolead
- National Institute on Drug Abuse (NIDA)collaborator
- Pfizercollaborator
Study Sites (1)
University of California San Francisco
San Francisco, California, 94143, United States
Related Publications (1)
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.
PMID: 37142273DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Gary Humfleet, PhD
- Organization
- University of California, San Francisco
Study Officials
- PRINCIPAL INVESTIGATOR
Gary Humfleet, Ph. D.
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2010
First Posted
July 14, 2010
Study Start
May 1, 2010
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
November 12, 2020
Results First Posted
November 12, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share