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Completed

NCT Number: NCT01162239

Maintaining Nonsmoking

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.

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Key information

Conditions

Nicotine Dependence Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Smoking Smoking Cessation Substance-Related Disorders Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of California San Francisco

San Francisco, California, 94143, United States

About this study

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

  • Monthly Brief Contact or
  • Extended Non-Specific Behavioral Treatment or
  • Extended Relapse Prevention Treatment or
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Varenicline

Drug

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

Initial Individual counseling

Behavioral

Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.

Check-ins with medical staff

Behavioral

Monthly brief (10-15 minutes) meetings with medical staff.

Extended Individual Counseling - Health Model

Behavioral

Monthly counseling sessions across a nine month period with content based on a health education model. Each session is 30-45 minutes in duration.

Extended Individual Counseling - Relapse Prevention Model

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • Pfizer

Registry information

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Jul 14, 2010
Registry last updated
Nov 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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