Maintaining Nonsmoking
This study is currently recruiting participants.
Verified November 2012 by University of California, San Francisco
Sponsor:
University of California, San Francisco
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01162239
First received: June 14, 2010
Last updated: November 8, 2012
Last verified: November 2012
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Purpose
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. 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. All participants will be assessed at weeks 12, 24, 52, 64, and 104, on smoking as well as other psychometric measures.
| Condition | Intervention | Phase |
|---|---|---|
|
Nicotine Dependence |
Drug: Varenicline Behavioral: Individual counseling Behavioral: Check-ins with medical staff Behavioral: individual counseling |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Maintaining Nonsmoking |
Resource links provided by NLM:
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- smoking status [ Time Frame: 12 weeks following treatment initiation ] [ Designated as safety issue: No ]
- smoking status [ Time Frame: 24 weeks following treatment initiation ] [ Designated as safety issue: No ]
- smoking status [ Time Frame: 52 weeks following treatment initiation ] [ Designated as safety issue: No ]
- smoking status [ Time Frame: 64 weeks following treatment initiation ] [ Designated as safety issue: No ]
- smoking status [ Time Frame: 104 weeks following treatment initiation ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 360 |
| Study Start Date: | May 2010 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Extended Brief Contact
Following standard brief treatment, participants have monthly meetings with medical staff.
|
Drug: Varenicline
All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Behavioral: Individual counseling
Five 90 minute individual counseling sessions.
Behavioral: Check-ins with medical staff
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.
|
Drug: Varenicline
All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Behavioral: Individual counseling
Five 90 minute individual counseling sessions.
Behavioral: individual counseling
Eleven individual counseling sessions across a nine month period. 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.
|
Drug: Varenicline
All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Behavioral: Individual counseling
Five 90 minute individual counseling sessions.
Behavioral: individual counseling
Eleven individual counseling sessions across a nine month period. 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.
|
Drug: Varenicline
All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Behavioral: Individual counseling
Five 90 minute individual counseling sessions.
Behavioral: individual counseling
Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 18 years of age
- smoking 5 or more cigarettes per day
Exclusion Criteria:
- history of bipolar/manic-depressive disorder
- schizophrenia
- acutely 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162239
Contacts
| Contact: Gary Humfleet, Ph.D. | 415-476-7674 | ghumfleet@lppi.ucsf.edu |
Locations
| United States, California | |
| University of California San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Principal Investigator: Sharon Hall, Ph.D. | |
Sponsors and Collaborators
University of California, San Francisco
More Information
No publications provided
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01162239 History of Changes |
| Other Study ID Numbers: | DA002538, 2R01DA002538 |
| Study First Received: | June 14, 2010 |
| Last Updated: | November 8, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
smoking tobacco nicotine smoking cessation |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Substance-Related Disorders Mental Disorders Varenicline Nicotinic Agonists Cholinergic Agonists |
Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013