Maintaining Nonsmoking

NCT01162239

Last updated date
Study Location
University of California San Francisco
San Francisco, California, 94143, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Nicotine Dependence
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- At least 18 years of age

- Must be smoking 5 or more cigarettes per day

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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)

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Advanced Information
Descriptive Information
Brief Title  ICMJE Maintaining Nonsmoking
Official Title  ICMJE Maintaining Nonsmoking
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nicotine Dependence
Intervention  ICMJE
  • 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.
    Other Name: Chantix
  • 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.
Study Arms  ICMJE
  • Experimental: Extended Brief Contact
    Following standard brief treatment, participants have monthly meetings with medical staff.
    Interventions:
    • Drug: Varenicline
    • Behavioral: Initial Individual counseling
    • Behavioral: Check-ins with medical staff
  • Experimental: Extended Health Education
    Following standard treatment, participants receive monthly counseling with content based on a health education model.
    Interventions:
    • Drug: Varenicline
    • Behavioral: Initial Individual counseling
    • Behavioral: Extended Individual Counseling - Health Model
  • 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.
    Interventions:
    • Drug: Varenicline
    • Behavioral: Initial Individual counseling
    • Behavioral: Extended Individual Counseling - Relapse Prevention Model
  • Experimental: Extended Relapse Prevention
    Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.
    Interventions:
    • Drug: Varenicline
    • Behavioral: Initial Individual counseling
    • Behavioral: Extended Individual Counseling - Relapse Prevention Model
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 19, 2020)
216
Original Estimated Enrollment  ICMJE
 (submitted: July 12, 2010)
360
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01162239
Other Study ID Numbers  ICMJE DA002538
2R01DA002538 ( U.S. NIH Grant/Contract )
11633 ( Other Identifier: University of California, San Francisco )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • Pfizer
Investigators  ICMJE
Principal Investigator:Gary Humfleet, Ph. D.University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP