Recruiting
Phase 3

NAW Regulation Training

Sponsor:

University of Alabama at Birmingham

Code:

NCT03912194

Conditions

Tobacco Dependence

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

cognitive-behavioral withdrawal regulation strategies

relaxation strategies

early withdrawal exposure

Study Details

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.

Conditions

Tobacco Dependence

Study ID

NCT03912194

Start date

Aug 1, 2019

Status verified date

Mar, 2026

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

cognitive-behavioral withdrawal regulation strategies

Participants will generate and refine individualized withdrawal regulation strategies with the aid of a therapist

relaxation strategies

Participants will generate and refine relaxation techniques with the aid of a therapist

early withdrawal exposure

Exposure to the first 4 hours of abstinence across 4 separate sessions

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 ]
  • Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence [ Time Frame: 3 months after end-of-treatment ]
  • Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence [ Time Frame: 6 months after end-of-treatment ]

Central Contacts and Locations

Locations

Ryals Public Health Building

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Peter S Hendricks, PhD

205.202.1387phendricks@uab.edu

Principal Investigator:

Peter S Hendricks, PhD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-03-11.