Overview

This trial is active, not recruiting.

Condition nicotine dependence
Treatments varenicline, individual counseling, check-ins with medical staff
Phase phase 3
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

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. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Following standard brief treatment, participants have monthly meetings with medical staff.
varenicline
All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
individual counseling
Five 90 minute individual counseling sessions.
check-ins with medical staff
Monthly brief (10-15 minutes) meetings with medical staff.
(Experimental)
Following standard treatment, participants receive monthly counseling with content based on a health education model.
varenicline
All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
individual counseling
Five 90 minute individual counseling sessions.
individual counseling
Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
(Experimental)
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline.
varenicline
All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
individual counseling
Five 90 minute individual counseling sessions.
individual counseling
Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
(Experimental)
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.
varenicline
All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
individual counseling
Five 90 minute individual counseling sessions.
individual counseling
Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.

Primary Outcomes

Measure
smoking status
time frame: 12 weeks following treatment initiation
smoking status
time frame: 24 weeks following treatment initiation
smoking status
time frame: 52 weeks following treatment initiation
smoking status
time frame: 64 weeks following treatment initiation
smoking status
time frame: 104 weeks following treatment initiation

Eligibility Criteria

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

Additional Information

Official title Maintaining Nonsmoking
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University of California, San Francisco.