Smoking Cessation
Conditions
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).
Interventions
BEHAVIORALWithdrawal regulation training
Withdrawal coping skills
BEHAVIORALRelaxation training
Relaxation skills instruction
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemically verified smoking abstinence | 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. |
| Biochemically-verified smoking abstinence | 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
| Measure | Time frame | Description |
|---|---|---|
| Withdrawal symptoms | 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. |
Countries
United States
Outcome results
None listed