NCT01162239

Maintaining Nonsmoking

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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 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

• Nicotine Dependence

Interventions

Type	Name	Description
DRUG	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.
BEHAVIORAL	Initial Individual counseling	Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.
BEHAVIORAL	Check-ins with medical staff	Monthly brief (10-15 minutes) meetings with medical staff.
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2010-05-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2010-07-14
• Last updated: 2020-11-12
• Results posted: 2020-11-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study