View Clinical Trial (Medical Research Study)
A Smoking Cessation Treatment for Adult Women
| City: |
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New Haven |
| State: |
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Connecticut |
| Zip Code: |
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06519 |
| Conditions: |
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Nicotine Dependence |
| Purpose: |
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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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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
- Be between the ages of 18 and 64 years old
- Meet DSM-IV criteria for nicotine dependence with 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 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)
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| NCT ID: |
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NCT01422239 |
| Primary Contact: |
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Principal Investigator
Andrea H. Weinberger, Ph.D.
Yale University
Andrea H. Weinberger, Ph.D.
Phone: 203-974-7598
Email: andrea.weinberger@yale.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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New Haven, Connecticut 06519
United States
Andrea H. Weinberger, Ph.D.
Phone: 203-974-7598
Email: andrea.weinberger@yale.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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