This trial is active, not recruiting.
|Treatments||varenicline, individual counseling, check-ins with medical staff|
|Sponsor||University of California, San Francisco|
|Collaborator||National Institute on Drug Abuse (NIDA)|
|Start date||May 2010|
|End date||July 2016|
|Trial size||271 participants|
|Trial identifier||NCT01162239, 2R01DA002538, DA002538|
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
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. All participants will be assessed at weeks 12, 24, 52, 64, and 104, on smoking as well as other psychometric measures.
|Intervention model||parallel assignment|
time frame: 12 weeks following treatment initiation
time frame: 24 weeks following treatment initiation
time frame: 52 weeks following treatment initiation
time frame: 64 weeks following treatment initiation
time frame: 104 weeks following treatment initiation
Male or female participants at least 18 years old.
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
|Official title||Maintaining Nonsmoking|
Call for more information