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Coping Skills Treatment for Smoking Cessation (Project-WIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01061528
Recruitment Status : Completed
First Posted : February 3, 2010
Results First Posted : June 15, 2018
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Butler Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Nicotine Dependence Drug: Transdermal Nicotine Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Distress Tolerance Treatment for Smoking Cessation
Study Start Date : September 2009
Actual Primary Completion Date : August 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Biochemically Verified Smoking Abstinence [ Time Frame: Six months ]
    1. Carbon monoxide of expired air
    2. Salivary cotinine level of saliva


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061528


Locations
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United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Richard A Brown, PhD Butler Hospital/Brown Medical School
More Information
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Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT01061528    
Other Study ID Numbers: PHI0906-002
R01DA017332 ( U.S. NIH Grant/Contract )
First Posted: February 3, 2010    Key Record Dates
Results First Posted: June 15, 2018
Last Update Posted: October 16, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Butler Hospital:
cigarette smoking
smoking cessation
nicotine dependence
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action