Clinical trial NCT02192762: Withdrawal Exposure With Withdrawal Regulation Training for Smoking Cessation
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2014-07-17
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Biochemically verified smoking abstinence
timeFrame: 2 months after end-of-treatment
measure: Biochemically-verified smoking abstinence
timeFrame: 3 months after end-of-treatment
Secondary outcomes:
measure: Withdrawal symptoms
timeFrame: 2 months after end-of-treatment
measure: Withdrawal symptoms
timeFrame: 3 months after end-of-treament
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Peter S Hendricks, PhD
role: PRINCIPAL_INVESTIGATOR
References: