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Withdrawal Exposure With Withdrawal Regulation Training for Smoking Cessation

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ClinicalTrials.gov Identifier: NCT02192762
Recruitment Status : Completed
First Posted : July 17, 2014
Last Update Posted : May 5, 2015
Sponsor:
Information provided by (Responsible Party):
Peter Hendricks, University of Alabama at Birmingham

Brief Summary:
This is a pilot study of a withdrawal regulation training program compared to relaxation training for individuals that are interested in smoking cessation.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Withdrawal regulation training Behavioral: Relaxation training Not Applicable

Detailed Description:

Participants will be recruited through newspaper and internet advertisements, advertisements on public transportation, community centers and community based organizations. All recruitment materials will contain a toll-free telephone number with 24-hour voice mail. The first contact with potential participant will be by telephone interview to assess for eligibility of participant. Participants who meet eligibility criteria will be invited to an orientation meeting where a breath carbon monoxide sample will be obtained. Women participant of childbearing potential will have a pregnancy test administered.

Participants will be randomized to one of two conditions: Early Withdrawal Exposure + Withdrawal Relaxation Training (E+WT) or Relaxation Training (RT) control. The E+WT condition will consist of the development, application, modification, and repeated practice of individualized withdrawal regulation for behavioral and cognitive strategies. the RT condition will control for the therapeutic contact received by those in the E+WT condition and will consist of the development, application, modification, and repeated practice of individualized relaxation techniques (e.g. breathing exercises, imagery).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of Withdrawal Regulation Training vs. Relaxation Training for Smoking Cessation (Withdrawal Exposure With Withdrawal Regulation Training for Smoking Cessation)
Study Start Date : July 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Withdrawal regulation training
Withdrawal coping skills
Behavioral: Withdrawal regulation training
Withdrawal coping skills

Active Comparator: Relaxation training
Relaxation skills instruction
Behavioral: Relaxation training
Relaxation skills instruction




Primary Outcome Measures :
  1. Biochemically verified smoking abstinence [ Time Frame: 2 months after end-of-treatment ]
    Smoking abstinence will be determined by self-report and confirmed via breath carbon monoxide (CO) analysis. Self-report of no smoking over the past 7 days (7-day point prevalence abstinence) and a CO value of less than 8 parts per million will be indicative of smoking abstinence. Self-report of any smoking over the past 7 days and/or CO values of 8 or greater will be indicative of cigarette use.

  2. Biochemically-verified smoking abstinence [ Time Frame: 3 months after end-of-treatment ]
    Smoking abstinence will be determined by self-report and confirmed via breath carbon monoxide (CO) analysis. Self-report of no smoking over the past 7 days (7-day point prevalence abstinence) and a CO value of less than 8 parts per million will be indicative of smoking abstinence. Self-report of any smoking over the past 7 days and/or CO values of 8 or greater will be indicative of cigarette use.


Secondary Outcome Measures :
  1. Withdrawal symptoms [ Time Frame: 2 months after end-of-treatment ]
    Withdrawal symptoms will be measured via self-report with the Wisconsin Smoking Withdrawal Scale (WSWS), a reliable and valid instrument of smoking withdrawal symptomatology.

  2. Withdrawal symptoms [ Time Frame: 3 months after end-of-treament ]
    Withdrawal symptoms will be measured via self-report with the Wisconsin Smoking Withdrawal Scale (WSWS), a reliable and valid instrument of smoking withdrawal symptomatology.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women at least 19 years of age
  • Reports smoking at least 10 cigarettes per day
  • Must have expired breath carbon monoxide reading of at least eight parts per million
  • Report the intention to quit smoking
  • Reside in the Birmingham area with no plan to relocate outside of the area in the next six months
  • Have access to a telephone for scheduling follow up assessments

Exclusion Criteria:

  • Inability to speak English
  • Presence of a condition that contraindicates use of transdermal nicotine patch (i.e. angina pectoris, arrhythmia, recent myocardial infarction, allergies to adhesives, serious skin disorders, and current pregnancy or breast feeding)
  • Presence of conditions that might interfere with compliance with protocol or greatly complicate treatment (i.e. current alcohol or other substance dependence, dementia, psychosis, schizophrenia, bipolar disorder, suicidal or homicidal ideation, and any disease acutely life-threatening or so severe that the participant cannot comply with the protocol)
  • Concurrent participation in a formal treatment program for smoking cessation
  • Current use of any pharmacotherapy for smoking cessation

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): NCT02192762


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Peter S Hendricks, PhD University of Alabama at Birmingham

Responsible Party: Peter Hendricks, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02192762     History of Changes
Other Study ID Numbers: F110601002
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015