Withdrawal Exposure With Withdrawal Regulation Training for Smoking Cessation

NCT ID: NCT02192762

Last Updated: 2022-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2014-12-31

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.

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).

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Withdrawal regulation training

Withdrawal coping skills

Group Type: EXPERIMENTAL

Withdrawal regulation training

Intervention Type: BEHAVIORAL

Withdrawal coping skills

Relaxation training

Relaxation skills instruction

Group Type: ACTIVE_COMPARATOR

Relaxation training

Intervention Type: BEHAVIORAL

Relaxation skills instruction

Interventions

Withdrawal regulation training

Withdrawal coping skills

Intervention Type: BEHAVIORAL

Relaxation training

Relaxation skills instruction

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Peter Hendricks

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter S Hendricks, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

F110601002

Identifier Type: -

Identifier Source: org_study_id