Tobacco DependencePhase 2NCT04969198
UW Withdraw From Tobacco Study
A Phase 2 study testing Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge) in people with Tobacco Dependence, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
It is of considerable scientific and clinical importance to assess tobacco withdrawal accurately since withdrawal severity is highly determinant of smoking cessation success. In addition, smoking cessation pharmacotherapy produces its effects on smoking abstinence by suppressing such symptoms. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2021to 21 Sep 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Smoke ≥5 cigarettes per day for past year
- ≥21 years old
- Able to read and write English
- Desire to quit smoking
- Not currently engaged in cessation treatment
- Eligible to use combination nicotine replacement therapy
Show all 11Show fewer
- Willing and able to attend study visits
- Have reliable smartphone access
- Not currently pregnant, trying to get pregnant, or breastfeeding
- Willing to respond to ecological momentary assessment prompts and other study activities
- Baseline breath carbon monoxide (CO) ≥5ppm
Who cannot join
- Used pipe tobacco, cigars, snuff, or chew more than twice in the past week
- Used e-cigarette, vaping, or any other electronic nicotine delivery product more than twice in the past week
- Unwilling to try to abstain from all non-medicinal nicotine use (including e-cigarettes) for the duration of the Cessation Phase (other than nicotine replacement therapy provided by the study)
- Currently taking varenicline or bupropion
- Allergy to adhesive tape
- Previous reaction to the nicotine patch or mini-lozenge that prevented them from continuing to use it
Show all 13Show fewer
- Unwilling to use study approved methods of birth control while taking study medication and for 1 month after discontinuing study medication [only for women of child-bearing potential]
- Hospitalized for a stroke, heart attack, congestive heart failure, ulcers, or diabetes within the last year
- History of seizure within the last year
- Diagnosis of and/or treatment for schizophrenia, other psychotic disorders, or bipolar disorder within the last 5 years
- End-stage renal disease
- Suicide attempt or suicidal ideation within the last 12 months
- Severe hypertension > 180/100 mmHg
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Tobacco Research and Intervention
Madison, Wisconsin, 53711
About this study
Official title: UW Withdraw From Tobacco Study: Enhancing and Evaluating Tobacco Withdrawal Assessment Psychometrics and Validity
It is of considerable scientific and clinical importance to assess tobacco withdrawal accurately since withdrawal severity is highly determinant of smoking cessation success. In addition, smoking cessation pharmacotherapy produces its effects on smoking abstinence by suppressing such symptoms. However, in order to ensure that a measure of tobacco withdrawal is sensitive to severe withdrawal, it is essential to examine a period of unmedicated abstinence. The current study aims to validate, and possibly enhance, a revised Wisconsin Smoking Withdrawal Scale long and brief version for use in research and clinical settings.
Two hundred adults who smoke cigarettes daily and report a desire to quit smoking will be enrolled. This is a treatment-delay, one-group clinical trial that is intended to enhance the assessment of tobacco withdrawal amongst participants who try to quit smoking with delayed use of cessation medication. Participants will not receive any pharmacotherapy during the first 1 week of their quit attempt and will initiate 8 weeks of combination nicotine replacement therapy (C-NRT; nicotine patch + nicotine mini-lozenge) starting 1 week past the target quit day (TQD). Participants will receive 4 counseling sessions as well (1 pre-quit, 3 post-quit). Participants will complete 4 weeks of ecological momentary assessment (EMA) smartphone surveys including a 2-week baseline (starting TQD-14) and 2-week post-TQD (1-week un-medicated, 1-week using C-NRT).
- Conditions
- Tobacco Dependence
- Being tested
- Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge)
- 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.
Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge)Drug
Also called C-NRT
Nicotine patch and mini-lozenge dosing will be based off the 2008 Public Health Services (PHS) Clinical Practice Guideline and package insert with adjustments to account for the delayed start 1-week post-TQD. All participants will receive 2mg mini-lozenge due to the superior palatability of the 2mg lozenges. Participants are encouraged to use at least 5 mini-lozenges per day for the full 8 weeks. Participants who report any smoking or nicotine use (e.g., even a cigarette puff, e-cigarette use) in the 3 days before C-NRT distribution will receive 4 weeks of 14mg and 4 weeks of 7mg nicotine patches. Participants who report complete abstinence from smoking and nicotine in the 3 days before C-NRT distribution will receive 8 weeks of 7mg nicotine patches.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Patch + Nicotine Mini Lozenge | Experimental | No medication for 1 Week after Target Quit Day (TQD). Medication started 1 Week after TQD.
Patches (Nicotine): 14 mg Patches for 4 weeks postquit (Week 1-5), then 7 mg patches for 4 weeks (Week 6-9)
Mini Lozenge (Nicotine): 2 mg Mini Lozenges 5x per day (up to 20x day max) for 8 weeks post quit (Week 1-9) Receives: Drug: Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Score on Wisconsin Smoking Withdrawal Scale2 Long (WSWS2-L)
Self-reported withdrawal symptom severity in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2(WSWS-2) Long Version.
WSWS-2 consists of 19 items. Each item answers on a scale from 1=not at all to 7=extremely, how much a participant has been bothered in the last 24 hours. Mean score from 1-7 is reported. Higher scores indicate more severe withdrawal symptoms.
Measured: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
Change in Wisconsin Smoking Withdrawal Scale2 Brief Score
Self-reported withdrawal symptom severity in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2(WSWS-2) Brief Version.
WSWS-2 consists of 6 items. Each item answers on a scale from 1=not at all to 7=extremely, how much a participant has been bothered in the last 24 hours. Higher scores indicate more severe withdrawal symptoms.
Measured: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
Secondary outcomes (9)
Change in WSWS2-L Subscale Score : Craving
Self-reported withdrawal symptom severity subscales (negative affect, craving, hunger, sleep, restlessness, concentration) in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2 Long Version. Each item answers on a scale from 1=not at all to 7=extremely, how much a participant has been bothered in the last 24 hours.
Measured: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
Change in WSWS2-L Subscale Score : Negative Affect
Self-reported withdrawal symptom severity subscales (negative affect, craving, hunger, sleep, restlessness, concentration) in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2 Long Version. Each item answers on a scale from 1=not at all to 7=extremely, how much a participant has been bothered in the last 24 hours.
Measured: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
Change in WSWS2-L Subscale Score : Concentration
Self-reported withdrawal symptom severity subscales (negative affect, craving, hunger, sleep, restlessness, concentration) in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2 Long Version. Each item answers on a scale from 1=not at all to 7=extremely, how much a participant has been bothered in the last 24 hours.
Measured: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
Change in WSWS2-L Subscale Score : Sleep Problems
Self-reported withdrawal symptom severity subscales (negative affect, craving, hunger, sleep, restlessness, concentration) in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2 Long Version. Each item answers on a scale from 1=not at all to 7=extremely, how much a participant has been bothered in the last 24 hours.
Measured: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
Change in WSWS2-L Subscale Score: Hunger
Self-reported withdrawal symptom severity subscales (negative affect, craving, hunger, sleep, restlessness, concentration) in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2 Long Version. Each item answers on a scale from 1=not at all to 7=extremely, how much a participant has been bothered in the last 24 hours.
Measured: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
Change in WSWS2-L Subscale Score : Restlessness
Self-reported withdrawal symptom severity subscales (negative affect, craving, hunger, sleep, restlessness, concentration) in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2 Long Version. Each item answers on a scale from 1=not at all to 7=extremely, how much a participant has been bothered in the last 24 hours.
Measured: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
9-Week Point-Prevalence Abstinence: Number of Participants Who Were Abstinent
Biochemically confirmed self-reported total abstinence from any cigarette use (even a single puff) for the seven days preceding the target follow up day, confirmed with carbon monoxide reading of less than or equal to 5 ppm.
Measured: 9 weeks after quit date
Change in Total Score on Minnesota Tobacco Withdrawal Scale (MTWS)
Self-reported withdrawal symptom severity in the last 24 hours using the Minnesota Tobacco Withdrawal Scale (MTWS). MTWS consists of 17 items. Mean score from 0 to 4 is reported. Higher scores indicate more severe withdrawal symptoms.
Measured: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
Change in WSWS2-L Subscale Score: Anhedonia
Exploratory subscale of the WSWS2-L, self-reported withdrawal symptom severity subscales (negative affect, craving, hunger, sleep, restlessness, concentration) in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2 Long Version. Each item answers on a scale from 1=not at all to 7=extremely, how much a participant has been bothered in the last 24 hours.
Measured: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start13 Jul 2021
- Primary completion21 Sep 2022
- Study completion21 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Timothy B Baker, PhD, Principal investigator, University of Wisconsin, MadisonJesse T Kaye, PhD, Study director, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969198
- Sponsor's protocol ID
- 2020-0792
- Other IDs
- A534253, SMPH/MEDICINE/GEN INT MD, 5R01HL109031, Protocol Version 2/21/2022
- Status last verified
- Nov 2023
- First submitted
- 9 Jul 2021
- Last updated
- 8 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will preregister their study design and publish the study protocol along with the publication of the primary outcome paper. Finally, investigators will make de-identified data and analysis code publicly available on the Open Science Framework (OSF: https://osf.io) or similar platform in accordance with NIH policy and principles of transparent science practices
Publications
Baker TB, Bolt DM, Piasecki TM, Kaye JT. Exploring the nature and relationship of tobacco cigarette craving and withdrawal. J Psychopathol Clin Sci. 2026 Sep 17. doi: 10.1037/abn0001171. Online ahead of print.
PubMed 42752171Kaye JT, Bolt DM, Piper ME, Cook JW, Williams BS, Piasecki TM, Baker TB. Assessing cigarette smoking withdrawal in unmedicated individuals: Validating the Wisconsin Smoking Withdrawal Scales Version 3 (WSWS3). Psychol Addict Behav. 2026 Aug 17:10.1037/adb0001174. doi: 10.1037/adb0001174. Online ahead of print.
PubMed 42606856
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UW Withdraw From Tobacco Study: Enhancing and Evaluating Tobacco Withdrawal Assessment Psychometrics and Validity
- ClinicalTrials.gov ID
- NCT04969198
- Acronym / sponsor ID
- 2020-0792
- Conditions
- Tobacco Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 21 Sep 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 20 Jul 2021 (actual)
- Results
- Posted 1 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is of considerable scientific and clinical importance to assess tobacco withdrawal accurately since withdrawal severity is highly determinant of smoking cessation success. In addition, smoking cessation pharmacotherapy produces its effects on smoking abstinence by suppressing such symptoms. However, in order to ensure that a measure of tobacco withdrawal is sensitive to severe withdrawal, it is essential to examine a period of unmedicated abstinence. The current study aims to validate, and possibly enhance, a revised Wisconsin Smoking Withdrawal Scale long and brief version for use in research and clinical settings.
Two hundred adults who smoke cigarettes daily and report a desire to quit smoking will be enrolled. This is a treatment-delay, one-group clinical trial that is intended to enhance the assessment of tobacco withdrawal amongst participants who try to quit smoking with delayed use of cessation medication. Participants will not receive any pharmacotherapy during the first 1 week of their quit attempt and will initiate 8 weeks of combination nicotine replacement therapy (C-NRT; nicotine patch + nicotine mini-lozenge) starting 1 week past the target quit day (TQD). Participants will receive 4 counseling sessions as well (1 pre-quit, 3 post-quit). Participants will complete 4 weeks of ecological momentary assessment (EMA) smartphone surveys including a 2-week baseline (starting TQD-14) and 2-week post-TQD (1-week un-medicated, 1-week using C-NRT).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nicotine Patch + Nicotine Mini Lozenge | Experimental | Drug: Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge)No medication for 1 Week after Target Quit Day (TQD). Medication started 1 Week after TQD. Patches (Nicotine): 14 mg Patches for 4 weeks postquit (Week 1-5), then 7 mg patches for 4 weeks (Week 6-9) Mini Lozenge (Nicotine): 2 mg Mini Lozenges 5x per day (up to 20x day max) for 8 weeks post quit (Week 1-9) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Smoke ≥5 cigarettes per day for past year
- ≥21 years old
- Able to read and write English
- Desire to quit smoking
- Not currently engaged in cessation treatment
Key exclusion criteria (13 listed)
- Used pipe tobacco, cigars, snuff, or chew more than twice in the past week
- Used e-cigarette, vaping, or any other electronic nicotine delivery product more than twice in the past week
- Unwilling to try to abstain from all non-medicinal nicotine use (including e-cigarettes) for the duration of the Cessation Phase (other than nicotine replacement therapy provided by the study)
- Currently taking varenicline or bupropion
- Allergy to adhesive tape
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 |
|---|---|---|
| Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge)Also: C-NRTNicotine patch and mini-lozenge dosing will be based off the 2008 Public Health Services (PHS) Clinical Practice Guideline and package insert with adjustments to account for the delayed start 1-week post-TQD. All participants will receive 2mg mini-lozenge due to the superior palatability of the 2mg lozenges. Participants are encouraged to use at least 5 mini-lozenges per day for the full 8 weeks. Participants who report any smoking or nicotine use (e.g., even a cigarette puff, e-cigarette use) in the 3 days before C-NRT distribution will receive 4 weeks of 14mg and 4 weeks of 7mg nicotine patches. Participants who report complete abstinence from smoking and nicotine in the 3 days before C-NRT distribution will receive 8 weeks of 7mg nicotine patches. | Drug | Nicotine Patch + Nicotine Mini Lozenge |
Primary outcome
Change in Total Score on Wisconsin Smoking Withdrawal Scale2 Long (WSWS2-L)
Time frame: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
Self-reported withdrawal symptom severity in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2(WSWS-2) Long Version. WSWS-2 consists of 19 items. Each item answers on a scale from 1=not at all to 7=extremely, how much a participant has been bothered in the last 24 hours. Mean score from 1-7 is reported. Higher scores indicate more severe withdrawal symptoms.
Change in Wisconsin Smoking Withdrawal Scale2 Brief Score
Time frame: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
Self-reported withdrawal symptom severity in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2(WSWS-2) Brief Version. WSWS-2 consists of 6 items. Each item answers on a scale from 1=not at all to 7=extremely, how much a participant has been bothered in the last 24 hours. Higher scores indicate more severe withdrawal symptoms.
9 secondary outcomes
Change in WSWS2-L Subscale Score : Craving
Time frame: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
Change in WSWS2-L Subscale Score : Negative Affect
Time frame: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
Change in WSWS2-L Subscale Score : Concentration
Time frame: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
Change in WSWS2-L Subscale Score : Sleep Problems
Time frame: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
Change in WSWS2-L Subscale Score: Hunger
Time frame: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
Change in WSWS2-L Subscale Score : Restlessness
Time frame: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
9-Week Point-Prevalence Abstinence: Number of Participants Who Were Abstinent
Time frame: 9 weeks after quit date
Change in Total Score on Minnesota Tobacco Withdrawal Scale (MTWS)
Time frame: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
Change in WSWS2-L Subscale Score: Anhedonia
Time frame: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42752171Baker TB, Bolt DM, Piasecki TM, Kaye JT. Exploring the nature and relationship of tobacco cigarette craving and withdrawal. J Psychopathol Clin Sci. 2026 Sep 17. doi: 10.1037/abn0001171. Online ahead of print.
- Derived from this study: PubMed 42606856Kaye JT, Bolt DM, Piper ME, Cook JW, Williams BS, Piasecki TM, Baker TB. Assessing cigarette smoking withdrawal in unmedicated individuals: Validating the Wisconsin Smoking Withdrawal Scales Version 3 (WSWS3). Psychol Addict Behav. 2026 Aug 17:10.1037/adb0001174. doi: 10.1037/adb0001174. Online ahead of print.
- University of Wisconsin Center for Tobacco Research and InterventionLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Investigators will preregister their study design and publish the study protocol along with the publication of the primary outcome paper. Finally, investigators will make de-identified data and analysis code publicly available on the Open Science Framework (OSF: https://osf.io) or similar platform in accordance with NIH policy and principles of transparent science practices
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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.
Timothy B Baker, PhD principal investigator
University of Wisconsin, Madison
Jesse T Kaye, PhD study director
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge) in people with Tobacco Dependence, run by University of Wisconsin, Madison 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 11 inclusion and 13 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: finished, as of the sponsor's last update on 8 May 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Total Score on Wisconsin Smoking Withdrawal Scale2 Long (WSWS2-L) (time frame: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04969198, which also lists 2 linked publications.
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 8 May 2025.