Tobacco Use CessationPhase 4SMARTTTNCT04490057

A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV

A Phase 4 study testing Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler, Varenicline or bupropion and Contingency Management in people with Tobacco Use Cessation, run by Yale University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Many people living with HIV (PLWH) smoke. Smoking in these individuals is often undertreated. This study plans to assess the ability of various clinical pathways involving tobacco treatment medications and contingency management (paying smokers for not smoking) to improve smoking cessation in a group of PLWH. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Tobacco Use Cessation
What is being tested?: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler, Varenicline or bupropion and Contingency Management
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 323 participants
Where: 4 sitesUnited States
Study dates: 27 Jul 2020to 24 Oct 2025
Phase: Phase 4
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

HIV positive;
>= 18 years old
Receiving HIV care at Yale-New Haven Hospital, Bridgeport Hospital, Mount Sinai Hospital, or SUNY Downstate STAR clinic;
Have smoked >= 100 cigarettes in lifetime;
Currently smokes some days or every day;
Smokes, on average, >= 5 cigarettes per day;
Able to provide written informed consent.

Who cannot join

Using only non-cigarette nicotine products (i.e., e-cigs, Juul, etc.);
Currently using NRT, VAR, or bupropion (defined as use in the prior 7 days);
Self-report or urine testing confirming pregnancy, nursing, or trying to conceive;
Life-threatening or unstable medical, surgical, or psychiatric condition;
Inability to provide at least one collateral contact (family member or friend);
Living out of state;
Unable to read or understand English (except at Mount Sinai site).

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Bridgeport Hospital Infectious Disease Clinic
Bridgeport, Connecticut, 06110
SUNY Downstate STAR Clinic
Brooklyn, New York, 11203
Yale University School of Medicine
New Haven, Connecticut, 06510
Icahn School of Medicine at Mount Sinai
New York, New York, 10029

Other trials in United States

About this study

Read the detailed description

Using a Sequential Multiple Assignment Randomized Trial (SMART) design, this project is a two-arm, two-stage randomized trial of 320 adult PWH who smoke cigarettes and receive care in one of three health systems (targeted enrollment changed from 632 to 320 with NCI approval and IRB protocol amendment). At inception, participants will be randomized to either combination nicotine replacement therapy (NRT, patch + short-acting NRT) or combination NRT+contingency management (CM). At 12 weeks, responders (non-smoking participants confirmed by exhaled carbon monoxide [eCO] or collateral verification) in both arms will receive 12 more weeks of the same treatment. Non-responders (participants with continued smoking by self-report and/or eCO) in both the NRT and NRT+CM arms will be re-randomized to 12 weeks of treatment, either with medication switch to oral medication, varenicline or bupropion, or intensified level of CM (start CM if no CM during first 12 weeks, or CM with higher reward schedule ["CM plus"] if NRT+CM group initially). The intervention will be delivered by trained clinical pharmacists. The primary outcomes will be self-reported reduction in average cigarettes smoked per day at 24 weeks and 12 weeks (primary outcome changed from eCO-confirmed abstinence to self-reported abstinence with NCI approval and IRB protocol amendment). The specific aims of the proposed study are to: (1) identify the optimal adaptive approach to promote reduced tobacco use (changed from eCO-confirmed smoking abstinence with NCI approval and protocol amendment) (2) study the effectiveness of various adaptive strategies on CD4 count, HIV viral suppression, and VACS index (validated measure of morbidity and mortality risk); and (3) grounded in implementation science and using aHybrid Effectiveness-Implementation Type I design, identify barriers and facilitators to delivering our intervention to inform future implementation.

Conditions: Tobacco Use Cessation
Being tested: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler, Varenicline or bupropion, Contingency Management
Medical subject headings: Tobacco Use Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhalerDrug
Participants will be prescribed both long-acting and short-acting nicotine replacement therapy.
Varenicline or bupropionDrug
Participants will be prescribed varenicline (Chantix) or bupropion (Wellbutrin).
Contingency ManagementBehavioural
Participants will be financially rewarded for abstinence to tobacco.

Study groups in NCT04490057
Study group	Role	What they receive
12 wks NRT+CM / 12 wks NRT+CM	Experimental	Nicotine replacement therapy combined with contingency management. Responders remain on same treatment for second 12 weeks. Receives: Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler; Behavioral: Contingency Management
12 wks NRT+CM/ 12 wks VAR or bupropion+CM	Experimental	Nicotine replacement therapy combined with contingency management. Non-responders switch to varenicline or bupropion combined with contingency management for second 12 weeks. Receives: Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler; Drug: Varenicline or bupropion; Behavioral: Contingency Management
12 wks NRT+CM/12 wks NRT+CM plus	Experimental	Nicotine replacement therapy combined with contingency management Non-responders switch to nicotine replacement therapy combined with intensified contingency management for second 12 weeks. Receives: Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler; Behavioral: Contingency Management
12 wks NRT/ 12 wks NRT	Experimental	Nicotine replacement therapy alone. Responders remain on nicotine replacement therapy. Receives: Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler
12 wks NRT/ 12 wks VAR or bupropion	Experimental	Nicotine replacement therapy alone. Non-responders switch to varenicline or bupropion alone for second 12 weeks. Receives: Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler; Drug: Varenicline or bupropion
12 wks NRT/ 12 wks NRT+CM	Experimental	Nicotine replacement therapy alone. Non-responders switch to nicotine replacement therapy combined with contingency management for second 12 weeks. Receives: Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler; Behavioral: Contingency Management

What is being measured

The primary outcome is the main question the study is designed to answer.

Self Reported Reduction in Average Cigarettes Smoked Per Day at 12 Weeks
Self reported reduction in average cigarettes smoked per day at 12 weeks
Measured: Week 12
Self Reported Reduction in Average Cigarettes Smoked Per Day at 24 Weeks
Self reported reduction in cigarettes smoked per day at 24 weeks
Measured: 24 weeks

Secondary outcomes (5)

Exhaled Carbon Monoxide (eCO) Confirmed Smoking Abstinence at 12 Weeks
Number of participants with smoking abstinence confirmed by exhaled carbon monoxide or next closest informant verification
Measured: 12 weeks from baseline
Exhaled Carbon Monoxide (eCO) Confirmed Smoking Abstinence at 24 Weeks
Number of participants with smoking abstinence confirmed by exhaled carbon monoxide or next closest informant verification
Measured: 24 weeks from baseline
VACS Index 2.0 Score
The Veterans Aging Cohort Study (VACS) 2.0 Index is A validated measure of morbidity and mortality. It estimates risk of 5-year all-cause mortality in patients with HIV. Total score range of 0-129. A higher total score indicates a greater risk of adverse health outcomes.
Measured: 24 weeks from baseline
CD4 Count
CD4 lymphocyte cell count. Normal range is 500-1200 cells per cubic millimeter. As HIV infection progresses, CD4 count drops.
Measured: 24 weeks from baseline
HIV Viral Load, Detectable
HIV viral load greater than 200 copies per milliliter of blood and detectable on standard lab test
Measured: 24 weeks from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jul 202024 Oct 2025

First posted28 Jul 2020
Study start27 Jul 2020
Primary completion24 Oct 2024
Study completion24 Oct 2025

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 Use CessationStudies of the same condition, open and under way.
More trials run by Yale UniversityThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: Sequential multiple assignment randomized trial
Masking: None (open label)
Enrolment: 323 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04490057
Sponsor's protocol ID: 2000026332
Other IDs: R01CA243910
Acronym: SMARTTT
Status last verified: Dec 2025
First submitted: 22 Jul 2020
Last updated: 5 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Edelman EJ, Deng Y, Dziura J, Nahum-Shani I, Weiss JM, Aoun-Barakat L, Bold KW, Harsono D, Mistler C, Payne E, Aiudi S, Sigel KM, Yager JE, Ledgerwood DM, Bernstein SL. Clinical Pharmacists, Medications, and Contingency Management for Targeting Smoking in HIV Clinics: A Randomized Clinical Trial. JAMA Netw Open. 2026 Feb 2;9(2):e2560593. doi: 10.1001/jamanetworkopen.2025.60593.
PubMed 41758512
Edelman EJ, Dziura J, Deng Y, Bold KW, Murphy SM, Porter E, Sigel KM, Yager JE, Ledgerwood DM, Bernstein SL. A SMARTTT approach to Treating Tobacco use disorder in persons with HIV (SMARTTT): Rationale and design for a hybrid type 1 effectiveness-implementation study. Contemp Clin Trials. 2021 Nov;110:106379. doi: 10.1016/j.cct.2021.106379. Epub 2021 Mar 29.
PubMed 33794354

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation

All Tobacco Use Cessation trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV
ClinicalTrials.gov ID: NCT04490057
Acronym / sponsor ID: SMARTTT / 2000026332
Conditions: Tobacco Use Cessation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 323 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 27 Jul 2020 (actual)
Primary completion: 24 Oct 2024 (actual)
Study completion: 24 Oct 2025 (actual)
First posted: 28 Jul 2020 (actual)
Results: Posted 28 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 6
Model description: Sequential multiple assignment randomized trial

Arm	Type	Receives
12 wks NRT+CM / 12 wks NRT+CM	Experimental	Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler, Behavioral: Contingency ManagementNicotine replacement therapy combined with contingency management. Responders remain on same treatment for second 12 weeks.
12 wks NRT+CM/ 12 wks VAR or bupropion+CM	Experimental	Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler, Drug: Varenicline or bupropion, Behavioral: Contingency ManagementNicotine replacement therapy combined with contingency management. Non-responders switch to varenicline or bupropion combined with contingency management for second 12 weeks.
12 wks NRT+CM/12 wks NRT+CM plus	Experimental	Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler, Behavioral: Contingency ManagementNicotine replacement therapy combined with contingency management Non-responders switch to nicotine replacement therapy combined with intensified contingency management for second 12 weeks.
12 wks NRT/ 12 wks NRT	Experimental	Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhalerNicotine replacement therapy alone. Responders remain on nicotine replacement therapy.
12 wks NRT/ 12 wks VAR or bupropion	Experimental	Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler, Drug: Varenicline or bupropionNicotine replacement therapy alone. Non-responders switch to varenicline or bupropion alone for second 12 weeks.
12 wks NRT/ 12 wks NRT+CM	Experimental	Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler, Behavioral: Contingency ManagementNicotine replacement therapy alone. Non-responders switch to nicotine replacement therapy combined with contingency management for second 12 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

HIV positive;
>= 18 years old
Receiving HIV care at Yale-New Haven Hospital, Bridgeport Hospital, Mount Sinai Hospital, or SUNY Downstate STAR clinic;
Have smoked >= 100 cigarettes in lifetime;
Currently smokes some days or every day;

Key exclusion criteria (7 listed)

Using only non-cigarette nicotine products (i.e., e-cigs, Juul, etc.);
Currently using NRT, VAR, or bupropion (defined as use in the prior 7 days);
Self-report or urine testing confirming pregnancy, nursing, or trying to conceive;
Life-threatening or unstable medical, surgical, or psychiatric condition;
Inability to provide at least one collateral contact (family member or friend);

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
Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhalerParticipants will be prescribed both long-acting and short-acting nicotine replacement therapy.	Drug	12 wks NRT+CM / 12 wks NRT+CM, 12 wks NRT+CM/ 12 wks VAR or bupropion+CM, 12 wks NRT+CM/12 wks NRT+CM plus, 12 wks NRT/ 12 wks NRT, 12 wks NRT/ 12 wks NRT+CM, 12 wks NRT/ 12 wks VAR or bupropion
Varenicline or bupropionParticipants will be prescribed varenicline (Chantix) or bupropion (Wellbutrin).	Drug	12 wks NRT+CM/ 12 wks VAR or bupropion+CM, 12 wks NRT/ 12 wks VAR or bupropion
Contingency ManagementParticipants will be financially rewarded for abstinence to tobacco.	Behavioural	12 wks NRT+CM / 12 wks NRT+CM, 12 wks NRT+CM/ 12 wks VAR or bupropion+CM, 12 wks NRT+CM/12 wks NRT+CM plus, 12 wks NRT/ 12 wks NRT+CM

Primary outcome

Self Reported Reduction in Average Cigarettes Smoked Per Day at 12 Weeks
Time frame: Week 12
Self reported reduction in average cigarettes smoked per day at 12 weeks
Self Reported Reduction in Average Cigarettes Smoked Per Day at 24 Weeks
Time frame: 24 weeks
Self reported reduction in cigarettes smoked per day at 24 weeks

5 secondary outcomes

Exhaled Carbon Monoxide (eCO) Confirmed Smoking Abstinence at 12 Weeks
Time frame: 12 weeks from baseline
Exhaled Carbon Monoxide (eCO) Confirmed Smoking Abstinence at 24 Weeks
Time frame: 24 weeks from baseline
VACS Index 2.0 Score
Time frame: 24 weeks from baseline
CD4 Count
Time frame: 24 weeks from baseline
HIV Viral Load, Detectable
Time frame: 24 weeks from baseline

Results and safety

Results posted to the registry on 28 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stage 1: NRT	163	160
Stage 1: NRT+CM	160	158
Stage 2: NRT Responders	0	0
Stage 2: Varenicline or Bupropion	0	0
Stage 2: NRT+CM	0	0
Stage 2: NRT+CM Responders	0	0
Stage 2: Varenicline or Bupropion + CM	0	0
Stage 2: NRT+CM Plus	0	0

Primary outcome: Self Reported Reduction in Average Cigarettes Smoked Per Day at 12 Weeks

Time frame: Week 12. Least squares mean (97.5% Confidence Interval). Unit: cigarettes per day

Measure	Stage 1: Nicotine Replacement only (NRT) n = 163	Stage 1: Nicotine Replacement (NRT) + Contingency Management (CM) n = 160
Value	5.2 (3.9 to 6.5)	4.9 (3.5 to 6.2)

Primary outcome: Self Reported Reduction in Average Cigarettes Smoked Per Day at 24 Weeks

Time frame: 24 weeks. Least squares mean (99% Confidence Interval). Unit: cigarettes per day

Measure	Stage 2: NRT responders n = 16	Stage 2: varenicline or bupropion n = 59	Stage 2: NRT+CM n = 56	Stage 2: NRT+CM responders n = 32	Stage 2: varenicline or bupropion + CM n = 39	Stage 2: NRT+CM plus n = 48
Value	7.90 (4.355 to 11.44)	6.23 (4.45 to 8.02)	2.97 (1.50 to 4.44)	10.92 (8.40 to 13.43)	4.00 (2.48 to 5.52)	4.20 (2.60 to 5.80)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Stage 1: up to 12 weeks; Stage 2: up to 24 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stage 1: NRT	13 of 163 (8%)	6 of 163 (3.7%)	1 of 163
Stage 1: NRT+CM	9 of 160 (5.6%)	14 of 160 (8.8%)	2 of 160
Stage 2: NRT Responders	1 of 16 (6.3%)	0 of 16 (0%)	0 of 16
Stage 2: Varenicline or Bupropion	5 of 70 (7.1%)	2 of 70 (2.9%)	0 of 70
Stage 2: NRT+CM	4 of 74 (5.4%)	0 of 74 (0%)	1 of 74
Stage 2: NRT+CM Responders	1 of 36 (2.8%)	1 of 36 (2.8%)	0 of 36
Stage 2: Varenicline or Bupropion + CM	3 of 60 (5%)	3 of 60 (5%)	0 of 60
Stage 2: NRT+CM Plus	3 of 62 (4.8%)	2 of 62 (3.2%)	0 of 62

Limitations and caveats (from the sponsor): 1\. The COVID-19 pandemic delayed enrollment leading to a reduction in sample size and change in endpoint to reduction in # of cigarettes/day. Due to these changes, we may have been underpowered to detect improved abstinence in Stage 2. 2. Participants were given prescriptions for medication, not actual medication and we observed access issues. 3. The study was conducted in urban HIV clinics in the Northeast US which may limit generalizability.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41758512Edelman EJ, Deng Y, Dziura J, Nahum-Shani I, Weiss JM, Aoun-Barakat L, Bold KW, Harsono D, Mistler C, Payne E, Aiudi S, Sigel KM, Yager JE, Ledgerwood DM, Bernstein SL. Clinical Pharmacists, Medications, and Contingency Management for Targeting Smoking in HIV Clinics: A Randomized Clinical Trial. JAMA Netw Open. 2026 Feb 2;9(2):e2560593. doi: 10.1001/jamanetworkopen.2025.60593.
Derived from this study: PubMed 33794354Edelman EJ, Dziura J, Deng Y, Bold KW, Murphy SM, Porter E, Sigel KM, Yager JE, Ledgerwood DM, Bernstein SL. A SMARTTT approach to Treating Tobacco use disorder in persons with HIV (SMARTTT): Rationale and design for a hybrid type 1 effectiveness-implementation study. Contemp Clin Trials. 2021 Nov;110:106379. doi: 10.1016/j.cct.2021.106379. Epub 2021 Mar 29.
Individual participant dataSharing planned: No

Related trials for Tobacco Use Cessation

Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation

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.

E. Jennifer Edelman, MD, MHS principal investigator

Yale University

Steven Bernstein, MD principal investigator

Dartmouth College

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 7 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 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 28 Nov 2025). 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?

Self Reported Reduction in Average Cigarettes Smoked Per Day at 12 Weeks (time frame: Week 12). 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 NCT04490057, 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 5 Jan 2026.