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NCT Number: NCT03912194

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

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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Key information

Conditions

Tobacco Dependence Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ryals Public Health Building

Birmingham, Alabama, 35294, United States

Location status: Recruiting

Location contact

Peter S Hendricks, PhD

CONTACT

[email protected]

205.202.1387

Peter S Hendricks, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence

    Time frame: 1 month after end-of-treatment

    Self reported abstinence from smoking ("no smoking, not even a puff) in the past seven days, biochemically confirmed by a breath carbon monoxide reading of 3 or less

  2. Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence

    Time frame: 3 months after end-of-treatment

    Self reported abstinence from smoking ("no smoking, not even a puff) in the past seven days, biochemically confirmed by a breath carbon monoxide reading of 3 or less

  3. Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence

    Time frame: 6 months after end-of-treatment

    Self reported abstinence from smoking ("no smoking, not even a puff) in the past seven days, biochemically confirmed by a breath carbon monoxide reading of 3 or less

Secondary outcomes

  1. Cessation milestones as determined by the Timeline Followback Interview

    Time frame: 1 month after end-of-treatment

    • Was initial abstinence achieved (was there any day of non-smoking within the first two weeks after the quit date; yes or no)?; 2) latency to lapse (number of days to the first cigarette after the quit day); 3) was there a progression from lapse to relapse (defined as seven consecutive days of smoking; yes or no)?

  2. Cessation milestones as determined by the Timeline Followback Interview

    Time frame: 3 months after end-of-treatment

    • latency to lapse (number of days to the first cigarette after the quit day); 2) was there a progression from lapse to relapse (defined as seven consecutive days of smoking; yes or no)?

  3. Cessation milestones as determined by the Timeline Followback Interview

    Time frame: 6 months after end-of-treatment

    • latency to lapse (number of days to the first cigarette after the quit day); 2) was there a progression from lapse to relapse (defined as seven consecutive days of smoking; yes or no)?

  4. Physical tobacco dependence

    Time frame: 1 month after end-of-treatment

    Tobacco dependence as measured by the Fagerstrom Test of Cigarette Dependence (FTCD). The FTCD is a widely used 9-item measure of physical dependence. FTCD scores, computed from the sum of the items, range from 0 to 10, with greater scores indicating greater dependence.

  5. Physical tobacco dependence

    Time frame: 3 months after end-of-treatment

    Tobacco dependence as measured by the Fagerstrom Test of Cigarette Dependence (FTCD). The FTCD is a widely used 9-item measure of physical dependence. FTCD scores, computed from the sum of the items, range from 0 to 10, with greater scores indicating greater dependence.

  6. Physical tobacco dependence

    Time frame: 6 months after end-of-treatment

    Tobacco dependence as measured by the Fagerstrom Test of Cigarette Dependence (FTCD). The FTCD is a widely used 9-item measure of physical dependence. FTCD scores, computed from the sum of the items, range from 0 to 10, with greater scores indicating greater dependence.

  7. Motivational tobacco dependence

    Time frame: 1 month after end-of-treatment

    Tobacco dependence as measured by the and the Wisconsin Inventory of Smoking Dependence Motives (WISDM) questionnaire. The WISDM-68 is a 68-item measure designed to assess dependence as a motivational state on 13 subscales: Affiliative Attachment, Automaticity, Loss of Control, Behavioral Choice, Cognitive Enhancement, Craving, Cue Exposure, Negative Reinforcement, Positive Reinforcement, Social and Environmental Goads, Taste and Sensory Properties, Tolerance, and Weight Control. Scores on each subscale, computed from the mean of their respective items, range from 1 to 7, with greater scores indicating greater dependence.

  8. Motivational tobacco dependence

    Time frame: 3 months after end-of-treatment

    Tobacco dependence as measured by the and the Wisconsin Inventory of Smoking Dependence Motives (WISDM) questionnaire. The WISDM-68 is a 68-item measure designed to assess dependence as a motivational state on 13 subscales: Affiliative Attachment, Automaticity, Loss of Control, Behavioral Choice, Cognitive Enhancement, Craving, Cue Exposure, Negative Reinforcement, Positive Reinforcement, Social and Environmental Goads, Taste and Sensory Properties, Tolerance, and Weight Control. Scores on each subscale, computed from the mean of their respective items, range from 1 to 7, with greater scores indicating greater dependence.

  9. Motivational tobacco dependence

    Time frame: 6 months after end-of-treatment

    Tobacco dependence as measured by the and the Wisconsin Inventory of Smoking Dependence Motives (WISDM) questionnaire. The WISDM-68 is a 68-item measure designed to assess dependence as a motivational state on 13 subscales: Affiliative Attachment, Automaticity, Loss of Control, Behavioral Choice, Cognitive Enhancement, Craving, Cue Exposure, Negative Reinforcement, Positive Reinforcement, Social and Environmental Goads, Taste and Sensory Properties, Tolerance, and Weight Control. Scores on each subscale, computed from the mean of their respective items, range from 1 to 7, with greater scores indicating greater dependence.

  10. Withdrawal symptoms

    Time frame: 1 month after end-of-treatment

    Withdrawal symptoms as measured by the 28-item Wisconsin Smoking Withdrawal Scale (WSWS). The WSWS measures smoking withdrawal symptoms on 7 subscales: Anger, Anxiety, Concentration, Craving, Hunger, Sadness, and Sleep Difficulty. Scores on each subscale, computed from the mean of their respective items, range from 0 to 4, with greater scores indicating greater withdrawal.

  11. Withdrawal symptoms

    Time frame: 3 months after end-of-treatment

    Withdrawal symptoms as measured by the 28-item Wisconsin Smoking Withdrawal Scale (WSWS). The WSWS measures smoking withdrawal symptoms on 7 subscales: Anger, Anxiety, Concentration, Craving, Hunger, Sadness, and Sleep Difficulty. Scores on each subscale, computed from the mean of their respective items, range from 0 to 4, with greater scores indicating greater withdrawal.

  12. Withdrawal symptoms

    Time frame: 6 months after end-of-treatment

    Withdrawal symptoms as measured by the 28-item Wisconsin Smoking Withdrawal Scale (WSWS). The WSWS measures smoking withdrawal symptoms on 7 subscales: Anger, Anxiety, Concentration, Craving, Hunger, Sadness, and Sleep Difficulty. Scores on each subscale, computed from the mean of their respective items, range from 0 to 4, with greater scores indicating greater withdrawal.

  13. Abstinence-related expectancies

    Time frame: 1 month after end-of-treatment

    Abstinence-related expectancies as measured by the 55-items Smoking Abstinence Questionnaire (SAQ). The SAQ measures expectancies for abstinence from smoking on 10 subscales: Withdrawal, Social Improvement/Non-smoker Identity, Adverse Outcomes, Treatment Effectiveness, Common Reasons, Barriers to Treatment, Social Support, Optimistic Outcomes, Coffee Use, and Weight Gain. Scores on each subscale, computed from the mean of their respective items, range from 0 to 6, with greater scores reflecting stronger expectancies.

  14. Abstinence-related expectancies

    Time frame: 3 months after end-of-treatment

    Abstinence-related expectancies as measured by the 55-item Smoking Abstinence Questionnaire (SAQ). The SAQ measures expectancies for abstinence from smoking on 10 subscales: Withdrawal, Social Improvement/Non-smoker Identity, Adverse Outcomes, Treatment Effectiveness, Common Reasons, Barriers to Treatment, Social Support, Optimistic Outcomes, Coffee Use, and Weight Gain. Scores on each subscale, computed from the mean of their respective items, range from 0 to 6, with greater scores reflecting stronger expectancies.

  15. Abstinence-related expectancies

    Time frame: 6 months after end-of-treatment

    Abstinence-related expectancies as measured by the 55-item Smoking Abstinence Questionnaire (SAQ). The SAQ measures expectancies for abstinence from smoking on 10 subscales: Withdrawal, Social Improvement/Non-smoker Identity, Adverse Outcomes, Treatment Effectiveness, Common Reasons, Barriers to Treatment, Social Support, Optimistic Outcomes, Coffee Use, and Weight Gain. Scores on each subscale, computed from the mean of their respective items, range from 0 to 6, with greater scores reflecting stronger expectancies.

  16. Thoughts about abstinence

    Time frame: 1 month after end-of-treatment

    Motivation to quit, expected difficulty quitting, and confidence in one's ability to quit are measured by one item each by the Thoughts About Abstinence (TAA) questionnaire. Scores on each item range from 1 to 10, with greater scores indicating greater motivation to quit, expected difficulty quitting, and confidence in one's ability to quit, respectively.

  17. Thoughts about abstinence

    Time frame: 3 months after end-of-treatment

    Motivation to quit, expected difficulty quitting, and confidence in one's ability to quit are measured by one item each by the Thoughts About Abstinence (TAA) questionnaire. Scores on each item range from 1 to 10, with greater scores indicating greater motivation to quit, expected difficulty quitting, and confidence in one's ability to quit, respectively.

  18. Thoughts about abstinence

    Time frame: 6 months after end-of-treatment

    Motivation to quit, expected difficulty quitting, and confidence in one's ability to quit are measured by one item each by the Thoughts About Abstinence (TAA) questionnaire. Scores on each item range from 1 to 10, with greater scores indicating greater motivation to quit, expected difficulty quitting, and confidence in one's ability to quit, respectively.

  19. Intolerance for smoking abstinence discomfort

    Time frame: 1 month after end-of-treatment

    Intolerance for smoking abstinence discomfort, as measured by the 17-tem Intolerance for Smoking Abstinence Discomfort Questionnaire (IDQ-S). The IDQ-S assesses the inability to tolerate smoking abstinence discomfort on two subscales: Withdrawal Intolerance and Lack of Cognitive Coping. Scores on each subscale, computed from the mean of their respective items, range from 1 to 5, with greater scores indicating greater inability to tolerate abstinence.

  20. Intolerance for smoking abstinence discomfort

    Time frame: 3 months after end-of-treatment

    Intolerance for smoking abstinence discomfort, as measured by the 17-item Intolerance for Smoking Abstinence Discomfort Questionnaire (IDQ-S). The IDQ-S assesses the inability to tolerate smoking abstinence discomfort on two subscales: Withdrawal Intolerance and Lack of Cognitive Coping. Scores on each subscale, computed from the mean of their respective items, range from 1 to 5, with greater scores indicating greater inability to tolerate abstinence.

  21. Intolerance for smoking abstinence discomfort

    Time frame: 6 months after end-of-treatment

    Intolerance for smoking abstinence discomfort, as measured by the 17-item Intolerance for Smoking Abstinence Discomfort Questionnaire (IDQ-S). The IDQ-S assesses the inability to tolerate smoking abstinence discomfort on two subscales: Withdrawal Intolerance and Lack of Cognitive Coping. Scores on each subscale, computed from the mean of their respective items, range from 1 to 5, with greater scores indicating greater inability to tolerate abstinence.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Apr 11, 2019
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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