Maintaining Nonsmoking

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01162239
First received: June 14, 2010
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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.

Condition Intervention Phase
Nicotine Dependence
Drug: Varenicline
Behavioral: Individual counseling
Behavioral: Check-ins with medical staff
Behavioral: individual counseling
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Maintaining Nonsmoking

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • smoking status [ Time Frame: 12 weeks following treatment initiation ] [ Designated as safety issue: No ]
  • smoking status [ Time Frame: 24 weeks following treatment initiation ] [ Designated as safety issue: No ]
  • smoking status [ Time Frame: 52 weeks following treatment initiation ] [ Designated as safety issue: No ]
  • smoking status [ Time Frame: 64 weeks following treatment initiation ] [ Designated as safety issue: No ]
  • smoking status [ Time Frame: 104 weeks following treatment initiation ] [ Designated as safety issue: No ]

Enrollment: 271
Study Start Date: May 2010
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Extended Brief Contact
Following standard brief treatment, participants have monthly meetings with medical staff.
Drug: Varenicline
All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Behavioral: Individual counseling
Five 90 minute individual counseling sessions.
Behavioral: Check-ins with medical staff
Monthly brief (10-15 minutes) meetings with medical staff.
Experimental: Extended Health Education
Following standard treatment, participants receive monthly counseling with content based on a health education model.
Drug: Varenicline
All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Behavioral: Individual counseling
Five 90 minute individual counseling sessions.
Behavioral: individual counseling
Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
Experimental: Extended Relapse Prevention plus varenicline
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline.
Drug: Varenicline
All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Behavioral: Individual counseling
Five 90 minute individual counseling sessions.
Behavioral: individual counseling
Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
Experimental: Extended Relapse Prevention
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.
Drug: Varenicline
All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Behavioral: Individual counseling
Five 90 minute individual counseling sessions.
Behavioral: individual counseling
Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01162239

Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01162239     History of Changes
Other Study ID Numbers: DA002538, 2R01DA002538
Study First Received: June 14, 2010
Last Updated: November 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
smoking
tobacco
nicotine
smoking cessation

Additional relevant MeSH terms:
Varenicline
Cholinergic Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014