ClinicalTrials.Veeva

Menu

Withdrawal Exposure With Withdrawal Regulation Training for Smoking Cessation

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Completed

Conditions

Smoking Cessation

Treatments

Behavioral: Withdrawal regulation training
Behavioral: Relaxation training

Study type

Interventional

Funder types

Other

Identifiers

NCT02192762
F110601002

Details and patient eligibility

About

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

Full 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).

Enrollment

60 patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

Withdrawal regulation training
Experimental group
Description:
Withdrawal coping skills
Treatment:
Behavioral: Withdrawal regulation training
Relaxation training
Active Comparator group
Description:
Relaxation skills instruction
Treatment:
Behavioral: Relaxation training

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems