Withdrawal Exposure With Withdrawal Regulation Training for Smoking Cessation
A Pilot Study of Withdrawal Regulation Training vs. Relaxation Training for Smoking Cessation (Withdrawal Exposure With Withdrawal Regulation Training for Smoking Cessation)
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 10, 2014
CompletedFirst Posted
Study publicly available on registry
July 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJanuary 13, 2022
December 1, 2021
3.4 years
April 10, 2014
December 26, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Biochemically verified smoking abstinence
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 months after end-of-treatment
Biochemically-verified smoking abstinence
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.
3 months after end-of-treatment
Secondary Outcomes (2)
Withdrawal symptoms
2 months after end-of-treatment
Withdrawal symptoms
3 months after end-of-treament
Study Arms (2)
Withdrawal regulation training
EXPERIMENTALWithdrawal coping skills
Relaxation training
ACTIVE COMPARATORRelaxation skills instruction
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter S Hendricks, PhD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 10, 2014
First Posted
July 17, 2014
Study Start
July 1, 2011
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
January 13, 2022
Record last verified: 2021-12