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Coping Skills Treatment for Smoking Cessation (Project WIN)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
Butler Hospital
ClinicalTrials.gov Identifier:
NCT01061528
First received: February 2, 2010
Last updated: June 28, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention
Nicotine Dependence
 Drug: Transdermal Nicotine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Distress Tolerance Treatment for Smoking Cessation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Butler Hospital:

Primary Outcome Measures:
  • Biochemically verified smoking abstinence via carbon monoxide and saliva cotinine. [ Time Frame: Six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 128
Study Start Date: September 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: New Smoking Cessation Counseling
  • One 60-minute individual session
  • Seven 2-hour group sessions
  • Two individual brief telephone contacts over an eight-week period.
  • Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.
 Drug: Transdermal Nicotine
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 Name: Nicoderm CQ
Active Comparator: Standard Smoking Cessation Counseling
  • One 60-minute individual session
  • Seven 2-hour group sessions
  • Two individual brief telephone contacts over an eight-week period.
  • Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.
 Drug: Transdermal Nicotine
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 Name: Nicoderm CQ

Detailed Description:
  1. 18-65 years of age,
  2. a regular smoker for at least one year,
  3. currently smoking 10 or more cigarettes per day,
  4. report motivation to quit smoking in the next month.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061528

Locations
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Richard A Brown, PhD Butler Hospital/Brown Medical School
  More Information

No publications provided

Responsible Party: Richard A. Brown, PhD, Butler Hospital/Brown Medical School
ClinicalTrials.gov Identifier: NCT01061528     History of Changes
Other Study ID Numbers: PHI0906-002, R01DA017332
Study First Received: February 2, 2010
Last Updated: June 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Butler Hospital:
cigarette smoking
smoking cessation
nicotine dependence

Additional relevant MeSH terms:
Tobacco Use Disorder
Smoking
Substance-Related Disorders
Mental Disorders
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013