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Completed

NCT Number: NCT02192762

Withdrawal Exposure With Withdrawal Regulation Training for Smoking Cessation

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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Withdrawal regulation training

Behavioral

Withdrawal coping skills

Relaxation Training

Behavioral

Relaxation skills instruction

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

A Pilot Study of Withdrawal Regulation Training vs. Relaxation Training for Smoking Cessation (Withdrawal Exposure With Withdrawal Regulation Training for Smoking Cessation)

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 17, 2014
Registry last updated
Jan 13, 2022

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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