Maintaining Nonsmoking

October 19, 2020 updated by: University of California, San Francisco
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Francisco, California, United States, 94143
        • University of California San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 18 years of age
  • Must be smoking 5 or more cigarettes per day

Exclusion Criteria:

  • Previous history of bipolar/manic-depressive disorder
  • Current diagnosis of schizophrenia
  • Acute 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
  • Individuals with out of normal range blood pressure, active angina, valve disease, valve replacement, active cardiomyopathies, myocardial infarction or Coronary artery bypass grafting (CABG) within one year, and Congestive heart failure (CHF)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Extended Brief Contact
Following standard brief treatment, participants have monthly meetings with medical staff.
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.
Other Names:
  • Chantix
Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.
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.
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.
Other Names:
  • Chantix
Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.
Monthly counseling sessions across a nine month period with content based on a health education model. 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.
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.
Other Names:
  • Chantix
Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.
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.
Experimental: Extended Relapse Prevention
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.
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.
Other Names:
  • Chantix
Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12
Time Frame: 12 weeks following treatment initiation
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 parts per million (ppm)) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent.
12 weeks following treatment initiation
Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24
Time Frame: 24 weeks following treatment initiation
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent.
24 weeks following treatment initiation
Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52
Time Frame: 52 weeks following treatment initiation
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent.
52 weeks following treatment initiation
Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64
Time Frame: 64 weeks following treatment initiation
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent.
64 weeks following treatment initiation
Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104
Time Frame: 104 weeks following treatment initiation
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent.
104 weeks following treatment initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Combined Extended vs Brief Treatment at Week 24
Time Frame: 24 weeks following treatment initiation
The three extended treatment programs were combined and compared to the Brief treatment, with extended treatments expected to produce significant higher CO corrected abstinence rates overall. Comparisons will be tested using Chi-Square analysis.
24 weeks following treatment initiation
Comparison of Combined Extended vs Brief Treatment at Week 52
Time Frame: 52 weeks following treatment initiation
The three extended treatment programs were combined and compared to the Brief treatment, with extended treatments expected to produce significant higher CO corrected abstinence rates overall. Comparisons will be tested using Chi-Square analysis.
52 weeks following treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Gary Humfleet, Ph. D., University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2010

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

June 14, 2010

First Submitted That Met QC Criteria

July 12, 2010

First Posted (Estimate)

July 14, 2010

Study Record Updates

Last Update Posted (Actual)

November 12, 2020

Last Update Submitted That Met QC Criteria

October 19, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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