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Eligibility
for people ages 18 years and up
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
estimated completion:
Principal Investigator

Description

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.

Keywords

Nicotine Dependence smoking tobacco nicotine smoking cessation Varenicline

Eligibility

You can join if…

Open to people ages 18 years and up

  • 18 years of age
  • smoking 5 or more cigarettes per day

You CAN'T join if...

  • 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

Location

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT01162239
Phase
Phase 3
Lead Scientist
Gary Humfleet
Study Type
Interventional
Last Updated
October 2015