Phase 1
Completed N=20
A Smoking Cessation Treatment for Adult Women
Source: ClinicalTrials.gov NCT01422239 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcomePrimary: Point-prevalence Smoking Abstinence Assessed at the End of the Trial and Measured by Self-report and Confirmed by Carbon Monoxide Levels — 4; 1 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Point-prevalence Smoking Abstinence Assessed at the End of the Trial and Measured by Self-report and Confirmed by Carbon Monoxide Levels |
4; 1 | — |
| SECONDARY Point-prevalence Smoking Abstinence Four Weeks After the End of the Trial Assessed by Self-report and Carbon Monoxide Levels |
2; 1 | — |
| SECONDARY Change in Smoking From Baseline to the Followup Assessment (Week 12) |
4.4; 2.0 | — |
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)
Data sourced from ClinicalTrials.gov (NCT01422239). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.