A Smoking Cessation Treatment for Adult Women

• ClinicalTrials.gov Identifier: NCT01422239
• Recruitment Status: Completed
• First Posted: August 23, 2011
• Results First Posted: June 7, 2013
• Last Update Posted: April 20, 2020
• Sponsor: Yale University
• Collaborator: National Institutes of Health (NIH)
• Information provided by (Responsible Party): Yale University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Nicotine Dependence	Behavioral: Tailored treatment; Behavioral: Standard Treatment	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Smoking Cessation Treatment for Adult Women
• Study Start Date: January 2011
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Point-prevalence Smoking Abstinence Assessed at the End of the Trial and Measured by Self-report and Confirmed by Carbon Monoxide Levels [ Time Frame: Up to 8 weeks ]
   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)

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 64 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

United States, Connecticut

Yale University School of Medicine, Department of Psychiatry

New Haven, Connecticut, United States, 06519

Sponsors and Collaborators

Yale University

National Institutes of Health (NIH)

Investigators

• Principal Investigator: Andrea H. Weinberger, Ph.D.; Yale University

More Information

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT01422239
• Other Study ID Numbers: 1007007059
• First Posted: August 23, 2011
• Results First Posted: June 7, 2013
• Last Update Posted: April 20, 2020
• Last Verified: April 2020

Keywords provided by Yale University:

smoking; treatment; perceived risks

Additional relevant MeSH terms:

Tobacco Use Disorder; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders