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Completed

NCT Number: NCT01422239

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.

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Key information

Conditions

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

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Yale University School of Medicine, Department of Psychiatry

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Tailored treatment

Behavioral

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.

Standard treatment

Behavioral

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.

Primary outcomes

  1. 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

    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)

Secondary outcomes

  1. Point-prevalence Smoking Abstinence Four Weeks After the End of the Trial Assessed by Self-report and Carbon Monoxide Levels

    Time frame: 12 weeks

    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)

  2. Change in Smoking From Baseline to the Followup Assessment (Week 12)

    Time frame: Week 0 (baseline), Week 12 (one month followup)

    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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 23, 2011
Registry last updated
Apr 20, 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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