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Completed

NCT Number: NCT01061528

Coping Skills Treatment for Smoking Cessation

The primary purpose of this study is to evaluate the efficacy of a new type of exposure- and acceptance-based smoking cessation treatment vs. standard behavioral smoking cessation treatment, in conjunction with the use of the transdermal nicotine patch. In both treatments, participants will receive one 60-minute individual session, seven 2-hour group sessions and two individual brief telephone contacts over an eight-week period. Both treatments include 8 weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue after the treatment sessions have ended. Participants will provide follow-up data with regard to their smoking status through a one-year follow-up period.

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Key information

Conditions

Nicotine Dependence Behavior Chemically-Induced Disorders Cigarette Smoking Health Behavior Mental Disorders Smoking Smoking Cessation Substance-Related Disorders Tobacco Smoking Tobacco Use Tobacco Use Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

About this study

  • 18-65 years of age,
  • a regular smoker for at least one year,
  • currently smoking 10 or more cigarettes per day,
  • report motivation to quit smoking in the next month.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-65 years old
  • regular smoker for at least one year
  • currently smoking 10 or more cigarettes per day

Exclusion criteria

  • Current Axis I disorder
  • Psychoactive substance abuse or dependence (excluding nicotine dependence) within past year
  • Current suicidal risk
  • Pregnancy or breast feeding
  • Use of nicotine replacement products or bupropion

Treatment and study plan

Transdermal Nicotine

Drug

Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment.

Other names: Nicoderm CQ

Primary outcomes

  1. Number of Participants With Biochemically Verified Smoking Abstinence

    Time frame: Six months

    • Carbon monoxide of expired air
    • Salivary cotinine level of saliva

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Distress Tolerance Treatment for Smoking Cessation

Acronym: Project-WIN

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Feb 3, 2010
Registry last updated
Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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