Clinical trial NCT01422239: A Smoking Cessation Treatment for Adult Women
Official title: A Smoking Cessation Treatment for Adult Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nicotine Dependence
Keywords: smoking
treatment
perceived risks
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2011-08-23
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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)

Primary outcomes:
measure: Point-prevalence Smoking Abstinence Assessed at the End of the Trial and Measured by Self-report and Confirmed by Carbon Monoxide Levels
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Point-prevalence Smoking Abstinence Four Weeks After the End of the Trial Assessed by Self-report and Carbon Monoxide Levels
timeFrame: 12 weeks
measure: Change in Smoking From Baseline to the Followup Assessment (Week 12)
timeFrame: Week 0 (baseline), Week 12 (one month followup)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine, Department of Psychiatry
state: Connecticut
Study officials:
affiliation: Yale University
name: Andrea H. Weinberger, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: