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.

Study Overview

• Status: Completed
• Conditions: Nicotine Dependence
• Intervention / Treatment: Behavioral: Tailored treatment; Behavioral: 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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale University School of Medicine, Department of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tailored behavioral counseling; The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's "Smoke Free and Living It" manual. The last 5 counseling sessions will be based on perceived risks of quitting.	Behavioral: Tailored treatment; 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.
Active Comparator: Standard behavioral counseling; The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's "Smoke Free and Living It" manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual.	Behavioral: Standard Treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Point-prevalence Smoking Abstinence Assessed at the End of the Trial and Measured by Self-report and Confirmed by Carbon Monoxide Levels	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)	Up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Point-prevalence Smoking Abstinence Four Weeks After the End of the Trial Assessed by Self-report and Carbon Monoxide Levels	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)	12 weeks
Change in Smoking From Baseline to the Followup Assessment (Week 12)	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.	Week 0 (baseline), Week 12 (one month followup)

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Andrea H. Weinberger, Ph.D., Yale University

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: August 19, 2011
• First Submitted That Met QC Criteria: August 22, 2011
• First Posted (Estimate): August 23, 2011

Study Record Updates

• Last Update Posted (Actual): April 20, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: treatment; smoking; perceived risks
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 1007007059

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No