Tobacco DependencePhase 3NCT03912194
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
A Phase 3 study testing cognitive-behavioral withdrawal regulation strategies, relaxation strategies and early withdrawal exposure in people with Tobacco Dependence, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- cognitive-behavioral withdrawal regulation strategies, relaxation strategies and early withdrawal exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 2 Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Ryals Public Health Building
Birmingham, Alabama, 35294
About this study
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.
Read the 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.
- Conditions
- Tobacco Dependence
- Being tested
- cognitive-behavioral withdrawal regulation strategies, relaxation strategies, early withdrawal exposure
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive-behavioral withdrawal regulation strategiesBehavioural
Participants will generate and refine individualized withdrawal regulation strategies with the aid of a therapist
relaxation strategiesBehavioural
Participants will generate and refine relaxation techniques with the aid of a therapist
early withdrawal exposureBehavioural
Exposure to the first 4 hours of abstinence across 4 separate sessions
| Study group | Role | What they receive |
|---|---|---|
| Early Withdrawal Exposure plus NAW Regulation Training | Experimental | 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. Receives: Behavioral: cognitive-behavioral withdrawal regulation strategies; Behavioral: early withdrawal exposure |
| Early Withdrawal Exposure plus Relaxation Control Training | Active comparator | The development, application, modification, and repeated practice of relaxation strategies across the first 4 hours of abstinence over 4 separate sessions. Receives: Behavioral: relaxation strategies; Behavioral: early withdrawal exposure |
| NAW Regulation Training Only | Active comparator | 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. Receives: Behavioral: cognitive-behavioral withdrawal regulation strategies |
| Relaxation Control Training Only | Active comparator | The development, application, modification, and repeated practice of relaxation strategies over 4 separate sessions involving smoking as usual. Receives: Behavioral: relaxation strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence
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
Measured: 1 month after end-of-treatment
Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence
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
Measured: 3 months after end-of-treatment
Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence
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
Measured: 6 months after end-of-treatment
Secondary outcomes (21)
Cessation milestones as determined by the Timeline Followback Interview
- 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)?
Measured: 1 month after end-of-treatment
Cessation milestones as determined by the Timeline Followback Interview
- 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)?
Measured: 3 months after end-of-treatment
Cessation milestones as determined by the Timeline Followback Interview
- 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)?
Measured: 6 months after end-of-treatment
Physical tobacco dependence
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.
Measured: 1 month after end-of-treatment
Physical tobacco dependence
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.
Measured: 3 months after end-of-treatment
Physical tobacco dependence
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.
Measured: 6 months after end-of-treatment
Motivational tobacco dependence
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.
Measured: 1 month after end-of-treatment
Motivational tobacco dependence
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.
Measured: 3 months after end-of-treatment
Motivational tobacco dependence
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.
Measured: 6 months after end-of-treatment
Withdrawal symptoms
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.
Measured: 1 month after end-of-treatment
Withdrawal symptoms
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.
Measured: 3 months after end-of-treatment
Withdrawal symptoms
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.
Measured: 6 months after end-of-treatment
Abstinence-related expectancies
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.
Measured: 1 month after end-of-treatment
Abstinence-related expectancies
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.
Measured: 3 months after end-of-treatment
Abstinence-related expectancies
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.
Measured: 6 months after end-of-treatment
Thoughts about abstinence
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.
Measured: 1 month after end-of-treatment
Thoughts about abstinence
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.
Measured: 3 months after end-of-treatment
Thoughts about abstinence
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.
Measured: 6 months after end-of-treatment
Intolerance for smoking abstinence discomfort
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.
Measured: 1 month after end-of-treatment
Intolerance for smoking abstinence discomfort
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.
Measured: 3 months after end-of-treatment
Intolerance for smoking abstinence discomfort
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.
Measured: 6 months after end-of-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start1 Aug 2019
- Primary completion2 Nov 2026 (estimated)
- Study completion2 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Peter Hendricks, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912194
- Sponsor's protocol ID
- 000522656
- Other IDs
- R01DA045186-01A1
- Status last verified
- Oct 2026
- First submitted
- 5 Apr 2019
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
- ClinicalTrials.gov ID
- NCT03912194
- Acronym / sponsor ID
- 000522656
- Conditions
- Tobacco Dependence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 2 Nov 2026 (estimated)
- Study completion
- 2 Nov 2026 (estimated)
- First posted
- 11 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Early Withdrawal Exposure plus NAW Regulation Training | Experimental | Behavioral: cognitive-behavioral withdrawal regulation strategies, Behavioral: early withdrawal exposureThe 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. |
| Early Withdrawal Exposure plus Relaxation Control Training | Active comparator | Behavioral: relaxation strategies, Behavioral: early withdrawal exposureThe development, application, modification, and repeated practice of relaxation strategies across the first 4 hours of abstinence over 4 separate sessions. |
| NAW Regulation Training Only | Active comparator | Behavioral: cognitive-behavioral withdrawal regulation strategiesThe 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. |
| Relaxation Control Training Only | Active comparator | Behavioral: relaxation strategiesThe development, application, modification, and repeated practice of relaxation strategies over 4 separate sessions involving smoking as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive-behavioral withdrawal regulation strategiesParticipants will generate and refine individualized withdrawal regulation strategies with the aid of a therapist | Behavioural | Early Withdrawal Exposure plus NAW Regulation Training, NAW Regulation Training Only |
| relaxation strategiesParticipants will generate and refine relaxation techniques with the aid of a therapist | Behavioural | Early Withdrawal Exposure plus Relaxation Control Training, Relaxation Control Training Only |
| early withdrawal exposureExposure to the first 4 hours of abstinence across 4 separate sessions | Behavioural | Early Withdrawal Exposure plus NAW Regulation Training, Early Withdrawal Exposure plus Relaxation Control Training |
Primary outcome
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
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
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
21 secondary outcomes
Cessation milestones as determined by the Timeline Followback Interview
Time frame: 1 month after end-of-treatment
Cessation milestones as determined by the Timeline Followback Interview
Time frame: 3 months after end-of-treatment
Cessation milestones as determined by the Timeline Followback Interview
Time frame: 6 months after end-of-treatment
Physical tobacco dependence
Time frame: 1 month after end-of-treatment
Physical tobacco dependence
Time frame: 3 months after end-of-treatment
Physical tobacco dependence
Time frame: 6 months after end-of-treatment
Motivational tobacco dependence
Time frame: 1 month after end-of-treatment
Motivational tobacco dependence
Time frame: 3 months after end-of-treatment
Motivational tobacco dependence
Time frame: 6 months after end-of-treatment
Withdrawal symptoms
Time frame: 1 month after end-of-treatment
Withdrawal symptoms
Time frame: 3 months after end-of-treatment
Withdrawal symptoms
Time frame: 6 months after end-of-treatment
Abstinence-related expectancies
Time frame: 1 month after end-of-treatment
Abstinence-related expectancies
Time frame: 3 months after end-of-treatment
Abstinence-related expectancies
Time frame: 6 months after end-of-treatment
Thoughts about abstinence
Time frame: 1 month after end-of-treatment
Thoughts about abstinence
Time frame: 3 months after end-of-treatment
Thoughts about abstinence
Time frame: 6 months after end-of-treatment
Intolerance for smoking abstinence discomfort
Time frame: 1 month after end-of-treatment
Intolerance for smoking abstinence discomfort
Time frame: 3 months after end-of-treatment
Intolerance for smoking abstinence discomfort
Time frame: 6 months after end-of-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cognitive-behavioral withdrawal regulation strategies, relaxation strategies and early withdrawal exposure in people with Tobacco Dependence, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.