Maintaining Nonsmoking

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.

Conditions

• Nicotine Dependence

Interventions

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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Pfizer

  collaborator INDUSTRY

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Gary Humfleet, Ph. D. · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2016-06-30

Completion

2016-06-30

FDA Drug

Yes

Countries

• United States

Study Locations