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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2026-06-24

Brief Summary

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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.

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Detailed Description

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Cigarette smoking remains the single most preventable cause of mortality and morbidity in the United States. Long-term abstinence rates for even the most rigorous of smoking cessation treatments range between 20% and 35%. It is therefore essential that research continue to investigate novel smoking cessation interventions. Leading contemporary theories of addiction motivation posit that the escape or avoidance of negative affect withdrawal (NAW) symptoms (e.g., anger, anxiety, and depression/sadness) constitutes a strong motivational basis for cigarette smoking and plays a critical role in relapse to cigarette use. However, whereas NAW symptoms appear to exert a powerful influence on smoking cessation treatment outcome, smoking cessation interventions may exert only modest effects on NAW symptoms. Accordingly, it has been proposed that smoking cessation interventions may be augmented by aiding smokers in the practice of NAW regulation strategies. The primary goal of this investigation is to evaluate an early withdrawal exposure plus NAW regulation training intervention for smoking cessation. Specific aims include evaluating the efficacy of the treatment components and investigating potential mediators and moderators of the treatment components. Participants will be adult smokers (N = 400) of at least 5 cigarettes per day with the intention to quit smoking. Using a factorial design, participants will be randomized to early withdrawal exposure (yes vs. no) and behavioral intervention (NAW regulation training vs. relaxation control training), resulting in four distinct conditions. The investigator's primary hypothesis is that early withdrawal exposure plus NAW regulation training will produce higher rates of seven-day point-prevalence abstinence at 1, 3, and 6 months after end-of-treatment, suggesting a synergistic (i.e., non-additive) effect of the two intervention components. Mediators (e.g., in-session withdrawal symptoms) and moderators (e.g., demographic characteristics, tobacco dependence) will be investigated via established analyses. These data will advance the experimental intervention with a focus on targeting mechanisms of change as well as participant characteristics to which the intervention may be tailored. The experimental intervention described in the current proposal has the potential to ultimately enhance the efficacy of existing smoking cessation interventions and will therefore contribute uniquely to the field.

Conditions

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Tobacco Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

cognitive-behavioral withdrawal regulation strategies

Intervention Type BEHAVIORAL

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

early withdrawal exposure

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

relaxation strategies

Intervention Type BEHAVIORAL

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

early withdrawal exposure

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

cognitive-behavioral withdrawal regulation strategies

Intervention Type BEHAVIORAL

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

Relaxation Control Training Only

The development, application, modification, and repeated practice of relaxation strategies over 4 separate sessions involving smoking as usual.

Group Type ACTIVE_COMPARATOR

relaxation strategies

Intervention Type BEHAVIORAL

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

Interventions

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cognitive-behavioral withdrawal regulation strategies

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

Intervention Type BEHAVIORAL

relaxation strategies

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

Intervention Type BEHAVIORAL

early withdrawal exposure

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes