A Smoking Cessation Treatment for Adult Women
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Tailored treatment; Standard Treatment
Intervention description: 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.; 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.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: Female
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: smoking; treatment; perceived risks

Summary:

      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.
    

Eligibility criteria:

        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)