A Smoking Cessation Treatment for Adult Women

Completed · Phase 1

Conditions studied: Nicotine Dependence

In brief

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.

Key facts

Study ID

NCT01422239

Run by

Yale University

People needed

28

Starts

2011-01-01

Expected to finish

2012-12-01

Last updated by the study team

2020-04-20

Who can join

Age: 18 and older, up to 64. Sex: female. Healthy volunteers: accepted.

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)

Where it is running

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

Full record on ClinicalTrials.gov

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