Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
2 other identifiers
interventional
400
1 country
1
Brief Summary
Smoking remains the single most preventable cause of morbidity and mortality in the United States, accounting for approximately half a million deaths every year. The current study will investigate the efficacy and mechanisms of change of a novel smoking cessation intervention. The current study will thus provide essential information regarding a treatment that has the potential to enhance the efficacy of existing smoking cessation interventions, thereby having a beneficial impact on the public health of the United States.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2019
Longer than P75 for phase_3
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
First Submitted
Initial submission to the registry
April 5, 2019
CompletedFirst Posted
Study publicly available on registry
April 11, 2019
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
March 11, 2026
March 1, 2026
6.9 years
April 5, 2019
March 9, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence
Self reported abstinence from smoking ("no smoking, not even a puff) in the past seven days, biochemically confirmed by a breath carbon monoxide reading of 3 or less
1 month after end-of-treatment
Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence
Self reported abstinence from smoking ("no smoking, not even a puff) in the past seven days, biochemically confirmed by a breath carbon monoxide reading of 3 or less
3 months after end-of-treatment
Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence
Self reported abstinence from smoking ("no smoking, not even a puff) in the past seven days, biochemically confirmed by a breath carbon monoxide reading of 3 or less
6 months after end-of-treatment
Secondary Outcomes (21)
Cessation milestones as determined by the Timeline Followback Interview
1 month after end-of-treatment
Cessation milestones as determined by the Timeline Followback Interview
3 months after end-of-treatment
Cessation milestones as determined by the Timeline Followback Interview
6 months after end-of-treatment
Physical tobacco dependence
1 month after end-of-treatment
Physical tobacco dependence
3 months after end-of-treatment
- +16 more secondary outcomes
Study Arms (4)
Early Withdrawal Exposure plus NAW Regulation Training
EXPERIMENTALThe development, application, modification, and repeated practice of individualized withdrawal regulation strategies (e.g., behavioral and cognitive strategies for allaying withdrawal symptoms) across the first 4 hours of abstinence over 4 separate sessions.
Early Withdrawal Exposure plus Relaxation Control Training
ACTIVE COMPARATORThe development, application, modification, and repeated practice of relaxation strategies across the first 4 hours of abstinence over 4 separate sessions.
NAW Regulation Training Only
ACTIVE COMPARATORThe development, application, modification, and repeated practice of individualized withdrawal regulation strategies (e.g., behavioral and cognitive strategies for allaying withdrawal symptoms) over 4 separate sessions involving smoking as usual.
Relaxation Control Training Only
ACTIVE COMPARATORThe development, application, modification, and repeated practice of relaxation strategies over 4 separate sessions involving smoking as usual.
Interventions
Participants will generate and refine individualized withdrawal regulation strategies with the aid of a therapist
Participants will generate and refine relaxation techniques with the aid of a therapist
Exposure to the first 4 hours of abstinence across 4 separate sessions
Eligibility Criteria
You may qualify if:
- at least 18 years of age
- smoke at least 5 cigarettes per day
- Expired breath carbon monoxide (CO) reading of at least five parts per million
- report the intention to quit
- reside in the Birmingham area with no plan to relocate outside of the area in the next 6 months
- access to a telephone
You may not qualify if:
- inability to speak English
- presence of a condition that contraindicates use of the nicotine patch
- presence of conditions that might interfere with compliance with the protocol or greatly complicate treatment
- any acutely life-threatening disease
- 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)
Ryals Public Health Building
Birmingham, Alabama, 35294, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- University Professor
Study Record Dates
First Submitted
April 5, 2019
First Posted
April 11, 2019
Study Start
August 1, 2019
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share