A Smoking Cessation Treatment for Adult Women

NCT01422239 | Completed Phase 1 Results

• 1 other identifier: 1007007059
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence

Keywords

smoking; treatment; perceived risks

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Point-prevalence Smoking Abstinence Four Weeks After the End of the Trial Assessed by Self-report and Carbon Monoxide Levels

  12 weeks

• Change in Smoking From Baseline to the Followup Assessment (Week 12)

  Week 0 (baseline), Week 12 (one month followup)

Study Arms (2)

Tailored behavioral counseling

EXPERIMENTAL

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

Standard behavioral counseling

ACTIVE COMPARATOR

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

Interventions

Tailored treatment BEHAVIORAL

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.

Tailored behavioral counseling

Standard Treatment BEHAVIORAL

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.

Standard behavioral counseling

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Yale University School of Medicine, Department of Psychiatry

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Limitations and Caveats

Small sample size, half to two-thirds of participants dropped out of the active study phase, half to one quarter did not complete the one month follow up. Female participants only results can not be generalized to men.

Results Point of Contact

• Title: Andrea Weinberger, Ph.D.
• Organization: Yale University School of Medicine

andrea.weinberger@yale.edu

203-974-7598

Study Officials

• Andrea H. Weinberger, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2011
• First Posted: August 23, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 20, 2020
• Results First Posted: June 7, 2013

Record last verified: 2020-04

Locations

US (1)