Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT03912194
Phase
PHASE3
Status
Recruiting
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Conditions

  • Tobacco Dependence

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • cognitive-behavioral withdrawal regulation strategies — BEHAVIORAL
    Participants will generate and refine individualized withdrawal regulation strategies with the aid of a therapist
  • relaxation strategies — BEHAVIORAL
    Participants will generate and refine relaxation techniques with the aid of a therapist
  • early withdrawal exposure — BEHAVIORAL
    Exposure to the first 4 hours of abstinence across 4 separate sessions

Study Details

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.

Key Dates

Start date
Aug 1, 2019
Status verified
Mar 2026
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Early Withdrawal Exposure plus NAW Regulation Training
    The 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.
  • Active Comparator: Early Withdrawal Exposure plus Relaxation Control Training
    The development, application, modification, and repeated practice of relaxation strategies across the first 4 hours of abstinence over 4 separate sessions.
  • Active Comparator: NAW Regulation Training Only
    The 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.
  • Active Comparator: Relaxation Control Training Only
    The development, application, modification, and repeated practice of relaxation strategies over 4 separate sessions involving smoking as usual.

Primary Outcome Measure

Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence [ Time Frame: 1 month after end-of-treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ryals Public Health BuildingBirminghamAlabama35294
Peter S Hendricks, PhD
[email protected]
205.202.1387
Peter S Hendricks, PhD (PRINCIPAL_INVESTIGATOR)

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Ryals Public Health Building· Birmingham, AL

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