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

The University of Alabama at Birmingham

Status and phase: Enrolling; Phase 3

Conditions: Tobacco Dependence

Treatments: Behavioral: early withdrawal exposure; Behavioral: relaxation strategies; Behavioral: cognitive-behavioral withdrawal regulation strategies

Study type: Interventional

Funder types: Other

Identifiers

NCT03912194

000522656

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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400 participants in 4 patient groups

Early Withdrawal Exposure plus NAW Regulation Training

Experimental group

Description:

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.

Treatment:

Behavioral: cognitive-behavioral withdrawal regulation strategies

Behavioral: early withdrawal exposure

Early Withdrawal Exposure plus Relaxation Control Training

Active Comparator group

Description:

The development, application, modification, and repeated practice of relaxation strategies across the first 4 hours of abstinence over 4 separate sessions.

Treatment:

Behavioral: relaxation strategies

Behavioral: early withdrawal exposure

NAW Regulation Training Only

Active Comparator group

Description:

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.

Treatment:

Behavioral: cognitive-behavioral withdrawal regulation strategies

Relaxation Control Training Only

Active Comparator group

Description:

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

Treatment:

Behavioral: relaxation strategies