A Smoking Cessation Treatment for Adult Women

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Andrea H. Weinberger, Yale University
ClinicalTrials.gov Identifier:
NCT01422239
First received: August 19, 2011
Last updated: June 6, 2013
Last verified: June 2013

August 19, 2011
June 6, 2013
January 2011
December 2012   (final data collection date for primary outcome measure)
Point-prevalence Smoking Abstinence Assessed at the End of the Trial and Measured by Self-report and Confirmed by Carbon Monoxide Levels [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
point-prevalence smoking abstinence assessed at the end of the trial and measured by self-report (no smoking reported in the previous 7 days) and confirmed by carbon monoxide levels (CO levels < 5ppm)
time to first cigarette after target quit date measured in days [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01422239 on ClinicalTrials.gov Archive Site
  • Point-prevalence Smoking Abstinence Four Weeks After the End of the Trial Assessed by Self-report and Carbon Monoxide Levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    point-prevalence smoking abstinence assessed at one month after the completion of counseling and measured by self-report (no smoking reported in the previous 7 days) and confirmed by carbon monoxide levels (CO levels < 5ppm)
  • Change in Smoking From Baseline to the Followup Assessment (Week 12) [ Time Frame: Week 0 (baseline), Week 12 (one month followup) ] [ Designated as safety issue: No ]
    Change in number of cigarettes per day (CPD) (averaged over the previous week) from the baseline assessment (Week 0) to the followup assessment (Week 12) for participants who did not quit smoking during the study.
  • point-prevalence smoking abstinence assessed at the end of the trial and measured by self-report and carbon monoxide levels [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • point-prevalence smoking abstinence four weeks after the end of the trial assessed by self-report and carbon monoxide levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Smoking Cessation Treatment for Adult Women
A Smoking Cessation Treatment for Adult Women

The purpose of this study is to develop and pilot test a smoking cessation counseling that focuses on the perceived risks of quitting smoking (e.g., weight gain, managing cravings and negative affect, loss of enjoyment).

Aim 1: To develop the risk-based smoking cessation intervention.

Aim 2: To examine whether manualized smoking cessation counseling about the perceived risks of quitting is feasible to administer and acceptable to adult women who want to quit smoking.

Aim 3: To examine smoking cessation outcomes for women who receive the risk-based treatment in comparison to standard smoking counseling. It is expected that women who receive risk-based counseling will show better quit rates and a longer time to relapse than women who receive standard treatment.

The purpose of this treatment development study is to design and pilot test a smoking cessation intervention in which counseling sessions are tailored to individual smokers' perceived risks of quitting. The feasibility, acceptability, and efficacy of the novel treatment will be examined through a pilot study in which female smokers will be randomly assigned to receive either the tailored treatment or a standard treatment. It is expected that participants receiving the tailored treatment will show higher rates of smoking abstinence than participants receiving the standard smoking cessation treatment at the end of the 8-week treatment and at one month follow-up.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Nicotine Dependence
  • Behavioral: Tailored treatment
    8 sessions of individual behavioral counseling. The first 3 sessions will be 45 minutes long and include 30 minutes tailored to the perceived risks of quitting most strongly held by each participant. The final 5 sessions will be 30 minutes long and include material from the Mayo Clinic's smoking cessation manual.
  • Behavioral: Standard Treatment
    8 sessions of individual behavioral counseling. The first 3 sessions will be 45 minutes long and include 30 minutes focused on the benefits of quitting smoking. The final 5 sessions will be 30 minutes long and include material from the Mayo Clinic's smoking cessation manual.
  • Experimental: Tailored behavioral counseling
    The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's "Smoke Free and Living It" manual. The last 5 counseling sessions will be based on perceived risks of quitting.
    Intervention: Behavioral: Tailored treatment
  • Active Comparator: Standard behavioral counseling
    The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's "Smoke Free and Living It" manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual.
    Intervention: Behavioral: Standard Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Between the ages of 18 and 64 years old
  • Meet Diagnostic and Statistical Manual-IV (DSM-IV) criteria for nicotine dependence with Fagerström Test for Nicotine Dependence (FTND) score ≥4
  • Smoke at least 15 cigarettes (3/4 pack) daily (averaged over 1 week, in the past 1 month) and have an expired breath carbon monoxide (CO) level ≥10
  • At the time of initial evaluation, are motivated to quit smoking in the next 30 days.
  • Have the capacity to give informed consent, and are English-speaking.

Exclusion Criteria:

  • Have a positive urine drug screen or urine pregnancy test at baseline evaluation
  • Meet DSM-IV criteria for alcohol or other drug abuse or dependence in the previous 6 months
  • Meet DSM-IV criteria for a current diagnosis of major depressive disorder, panic disorder or post-traumatic stress disorder
  • Meet DSM-IV criteria for a current or past diagnosis of bipolar disorder or schizophrenia
  • Are currently receiving treatment for nicotine dependence (e.g., nicotine replacement therapy, bupropion, chantix)
Female
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01422239
AHW-WHRY-526
No
Andrea H. Weinberger, Yale University
Yale University
National Institutes of Health (NIH)
Principal Investigator: Andrea H. Weinberger, Ph.D. Yale University
Yale University
June 2013

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