Clinical trial NCT03912194: Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Official title: Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Tobacco Dependence
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence
timeFrame: 1 month after end-of-treatment
measure: Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence
timeFrame: 3 months after end-of-treatment
measure: Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence
timeFrame: 6 months after end-of-treatment
Secondary outcomes:
measure: Cessation milestones as determined by the Timeline Followback Interview
timeFrame: 1 month after end-of-treatment
measure: Cessation milestones as determined by the Timeline Followback Interview
timeFrame: 3 months after end-of-treatment
measure: Cessation milestones as determined by the Timeline Followback Interview
timeFrame: 6 months after end-of-treatment
measure: Physical tobacco dependence
timeFrame: 1 month after end-of-treatment
measure: Physical tobacco dependence
timeFrame: 3 months after end-of-treatment
measure: Physical tobacco dependence
timeFrame: 6 months after end-of-treatment
measure: Motivational tobacco dependence
timeFrame: 1 month after end-of-treatment
measure: Motivational tobacco dependence
timeFrame: 3 months after end-of-treatment
measure: Motivational tobacco dependence
timeFrame: 6 months after end-of-treatment
measure: Withdrawal symptoms
timeFrame: 1 month after end-of-treatment
measure: Withdrawal symptoms
timeFrame: 3 months after end-of-treatment
measure: Withdrawal symptoms
timeFrame: 6 months after end-of-treatment
measure: Abstinence-related expectancies
timeFrame: 1 month after end-of-treatment
measure: Abstinence-related expectancies
timeFrame: 3 months after end-of-treatment
measure: Abstinence-related expectancies
timeFrame: 6 months after end-of-treatment
measure: Thoughts about abstinence
timeFrame: 1 month after end-of-treatment
measure: Thoughts about abstinence
timeFrame: 3 months after end-of-treatment
measure: Thoughts about abstinence
timeFrame: 6 months after end-of-treatment
measure: Intolerance for smoking abstinence discomfort
timeFrame: 1 month after end-of-treatment
measure: Intolerance for smoking abstinence discomfort
timeFrame: 3 months after end-of-treatment
measure: Intolerance for smoking abstinence discomfort
timeFrame: 6 months after end-of-treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Ryals Public Health Building
state: Alabama
Study officials:
References: