Cigarette Smoking-Related CarcinomaNCT03856515
Gender Differences in Switching From Smoking Regular Cigarettes to E-Cigarettes
A study testing Nicotine Replacement, Questionnaire Administration and Electronic Cigarette in people with Cigarette Smoking-Related Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This early phase I trial studies potential differences between men and women when switching from the use of combustible cigarettes to the National Institute on Drug Abuse's Standard Research E-Cigarette (SREC). Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking-Related Carcinoma
- What is being tested?
- Nicotine Replacement, Questionnaire Administration and Electronic Cigarette
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2022to 7 Jan 2026
- Phase
- Interventional
- 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
- Aged 21 years or older
- Reports being a daily or non-daily smoker (any self-reported smoking in the past 30 days)
- Have an address where he/she can receive mail
- Able to follow verbal and written instructions in English and complete all aspects of the study as determined by PI
- Willing to have urine biospecimen samples taken, either in-home and returning them by mail, or in-person at an approved collection site.
- Willing to use tobacco-flavored study electronic cigarettes
- Agrees to comply with all MD Anderson institutional policies related to COVID-19 screening prior to any in-person research visit.
- The individual agrees to not engage in study procedures or interactions with study personnel while operating a vehicle.
Who cannot join
- Individuals who report depressive symptoms in the moderately severe or severe range on the PHQ-9 (scores of 15 or above) or who report current suicidal ideation on the PHQ-9
- Uncontrolled or unstable medical condition (e.g., uncontrolled hypertension, angina, diabetes).
- Evidence of cognitive deficits or instability that would preclude reliable study participation.
- Being pregnant, engaging in breast-feeding, or being of childbearing potential and engaging in sexual activity that could lead to pregnancy and is not protected by a medically acceptable, effective method of birth control while enrolled in the study, as determined by self-report. Medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD). Contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use.
- Considered by the investigator to be an unsuitable or unstable candidate (including but not limited to the following situation: unwilling or unable to comply with study procedures)
- Individuals who reside in an area that is outside of our shipping company's area of operation or in a jurisdiction outside of our medical staff's licensure (if unable to attend in-person clinic visits) AND who decline or are unable to come in to clinic to provide necessary samples and/or collect study products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gender Differences in Standardized Research E-Cigarette (SREC) Product Use, Acceptability, Reinforcement, and Nicotine Dependence Symptoms
This early phase I trial studies potential differences between men and women when switching from the use of combustible cigarettes to the National Institute on Drug Abuse's Standard Research E-Cigarette (SREC). Studying the differences between men and women may increase understanding about the effects of switching from smoking regular cigarettes to electronic cigarettes.
Read the detailed description
PRIMARY OBJECTIVES:
- To characterize the effects of switching to nicotine versus (vs.) placebo standard research E-cigarettes (SRECs) from combustible cigarettes (CCs) on product use, product acceptability, reinforcement, and nicotine dependence symptoms among adult daily CC smokers.
II. To characterize the differences between male and female CC smokers when switching to nicotine versus (vs.) placebo SRECs from CCs on product use, product acceptability, reinforcement, and nicotine dependence symptoms.
EXPLORATORY OBJECTIVE:
- To characterize which factors moderate or mediate the effects of switching to nicotine and placebo SRECs from CCs among male and female CC smokers.
OUTLINE:
Participants will be instructed to smoke their usual brand cigarette as they normally would in weeks 1-2 (Phase I) and to use only the SREC (with or without nicotine) in weeks 3-4 (Phase II) and in weeks 5-6 (Phase III). Participant assignment to SREC type at Phases II and III will be counter-balanced within group, with half of men and women receiving the placebo SREC during Phase II and half during Phase III. Participants will attend 4 laboratory visits with study investigators for 3 hours each over 6 weeks of study participation.
- Conditions
- Cigarette Smoking-Related Carcinoma
- Being tested
- Nicotine Replacement, Questionnaire Administration, Electronic Cigarette
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine ReplacementDrug
Also called Nicotine Replacement Therapy, NRT
Received NRT (Electronic Cigarette - With Nicotine)
Questionnaire AdministrationOther
Ancillary studies
Electronic CigaretteDevice
Electronic Cigarette - with Nicotine
Electronic CigaretteDevice
Electronic Cigarette -without Nicotine
| Study group | Role | What they receive |
|---|---|---|
| E-Cig placebo dose followed by E-Cig nicotine dose | Experimental | Participants will be instructed to smoke their usual brand cigarette as they normally would in weeks 1-2 (Phase I) and to use only the SREC (with or without nicotine) in weeks 3-4 (Phase II) and in weeks 5-6 (Phase III). Participant assignment to SREC type at Phases II and III will be counter-balanced within group, with half of men and women receiving the placebo SREC during Phase II and half during Phase III. Participants will attend 4 laboratory visits with study investigators for 3 hours each over 6 weeks of study participation. Receives: Drug: Nicotine Replacement; Other: Questionnaire Administration; Device: Electronic Cigarette |
| E-Cig nicotine dose followed by E-Cig placebo dose | Experimental | Participants will be instructed to smoke their usual brand cigarette as they normally would in weeks 1-2 (Phase I) and to use only the SREC (with or without nicotine) in weeks 3-4 (Phase II) and in weeks 5-6 (Phase III). Participant assignment to SREC type at Phases II and III will be counter-balanced within group, with half of men and women receiving the placebo SREC during Phase II and half during Phase III. Participants will attend 4 laboratory visits with study investigators for 3 hours each over 6 weeks of study participation. Receives: Drug: Nicotine Replacement; Other: Questionnaire Administration; Device: Electronic Cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cigarettes Per Day
Mean cigarettes per day (CPD) smoked during the phase
Measured: 2 weeks
Secondary outcomes (21)
Electronic Cigarette Sessions Per Day
Study electronic cigarette use measured by the mean number of sessions per day during each phase for male and female participants.
Measured: 2 weeks
Total Nicotine Equivalents (TNE)
A measure of nicotine exposure, calculated as the sum of total nicotine, cotinine, 3'-hydroxycotinine, and nicotine N-oxide excreted in urine, collected at the end of each phase for male and female participants.
Measured: 2 weeks
Anabasine
A tobacco minor alkaloid (MA) excreted in urine collected at the end of each phase for male and female participants to evaluate nicotine product exposure.
Measured: 2 weeks
Nicotelline
A tobacco minor alkaloid (MA) excreted in urine collected at the end of each phase for male and female participants to evaluate nicotine product exposure.
Measured: 2 weeks
Perceived Health Risk Questionnaire (PHRQ)
Evaluation of participants' beliefs about their risks of developing health conditions from cigarettes or electronic cigarette collected at the end of each phase for male and female participants. Range 1-10, with higher values indicating greater perceived risk of negative health outcomes.
Measured: 2 weeks
Product Evaluation Scales (PES)
Evaluation of explicit cigarette or electronic cigarette product liking collected at the end of each phase for male and female participants. Range 1-7, with higher values indicating more unpleasant ratings.
Measured: 2 weeks
Implicit Association Test (IAT)
Evaluation of implicit cigarette or electronic cigarette liking collected at the end of each phase for male and female participants. Range: -1 to 1, with more negative values indicating a more negative attitude toward the cigarette product
Measured: 2 weeks
Brief Smoking Consequences Questionnaire-Adult (BSCQ-A)
Evaluation of the perceived outcomes of cigarette or electronic cigarette use collected at the end of each phase for male and female participants. Range 0 to 9, with larger values indicating greater perceived negative consequences of cigarette use
Measured: 2 weeks
Purchase Task Breakpoint Measure
Evaluation of the Purchase Task Breakpoint measure (first price at which consumption goes to zero, i.e., unwilling to pay) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 0.05 - 251, dollars per cigarette or per electronic cigarette puff with higher values indicating the willingness to smoke/vape at a higher price.
Measured: 2 weeks
Purchase Task Demand Intensity Measure
Evaluation of the Purchase Task Demand Intensity measure (consumption at the lowest price) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 1 - 351, the number of cigarettes or electronic cigarette puffs with higher values indicating an intension to smoke/vape more when the price is set as 0
Measured: 2 weeks
Purchase Task Omax Measure
Evaluation of the Purchase Task Omax measure (maximum financial expenditure on the product) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 0.03 - 1001, the maximum expenditure in dollars on cigarettes or electronic cigarette puffs with higher values indicating greater expenditure
Measured: 2 weeks
Purchase Task Pmax Measure
Evaluation of the Purchase Task Pmax measure (price at which expenditure is maximized) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 0.01 - 1001, the price of the cigarette or electronic cigarette puffs when the Omax is reached
Measured: 2 weeks
Purchase Task Elasticity of Demand Measure
Evaluation of the Purchase Task Elasticity of Demand measure (sensitivity of product consumption to increases in cost) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 0.0001 - 2.69, the elasticity of the demand for cigarettes or electronic cigarette puffs, with higher values indicating a greater sensitivity in reducing the consumption in response to the price increases
Measured: 2 weeks
Fagerström Test for Cigarette Dependence (FTCD)
Evaluation of cigarette dependence collected at the end of each phase for male and female participants. Range 0 to 10, with higher values indicating greater cigarette dependence
Measured: 2 weeks
Penn State Electronic Cigarette Dependence Index (PSECDI)
Evaluation of electronic cigarette dependence collected at the end of each phase for male and female participants. Range 0 to 20, with higher scores indicating greater electronic cigarette dependence
Measured: 2 weeks
Minnesota Nicotine Withdrawal Scale-Revised (MNWS)
Evaluation of nicotine withdrawal symptoms collected at the end of each phase for male and female participants. Range 0 to 60, with higher scores indicating greater nicotine withdrawal
Measured: 2 weeks
Questionnaire of Smoking Urges-Brief (QSU-Brief)
Evaluation of the craving to smoke cigarettes collected at the end of each phase for male and female participants. Range 1 to 10, with higher values indicating greater urge to smoke
Measured: 2 weeks
Positive and Negative Affect Scales - Positive Affect Scale (PANAS-Pos)
Evaluation of positive affect collected at the end of each phase for male and female participants. Range 10 to 50, with higher scores indicating greater positive affect
Measured: 2 weeks
Positive and Negative Affect Scales - Negative Affect Scale (PANAS-Neg)
Evaluation of negative affect collected at the end of each phase for male and female participants. Range 10 to 50, with higher scores indicating greater negative affect
Measured: 2 weeks
Smartphone Daily Measures of Nicotine Dependence Symptoms
Evaluation of mean nicotine dependence symptoms collected daily during each phase. Range 1 to 5, with higher values indicating greater nicotine dependence symptoms
Measured: 2 weeks
American Thoracic Society Questionnaire (ATSQ)
Evaluation of respiratory symptoms collected at the end of each phase for male and female participants. Range 8 to 40, with higher numbers indicating more respiratory symptoms
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start2 Jun 2022
- Primary completion24 Jun 2024
- Study completion7 Jan 2026
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 (1)Papers the sponsor has linked to this study.
- Other trials for Cigarette Smoking-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Jason Robinson, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856515
- Sponsor's protocol ID
- 2018-0794
- Other IDs
- NCI-2018-03354, 2018-0794, U01DA047875
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2019
- Last updated
- 28 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Robinson JD, Cui Y, Karam-Hage M, Blalock JA, Shete S, Kypriotakis G, Yang P, Cinciripini PM. Standardized research electronic cigarette acceptability among adult men and women who smoke combustible cigarettes. Psychol Addict Behav. 2025 Dec;39(8):780-791. doi: 10.1037/adb0001100. Epub 2025 Oct 6.
PubMed 41051837
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Differences in Standardized Research E-Cigarette (SREC) Product Use, Acceptability, Reinforcement, and Nicotine Dependence Symptoms
- ClinicalTrials.gov ID
- NCT03856515
- Acronym / sponsor ID
- 2018-0794
- Conditions
- Cigarette Smoking-Related Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 7 Jan 2026 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Posted 14 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This early phase I trial studies potential differences between men and women when switching from the use of combustible cigarettes to the National Institute on Drug Abuse's Standard Research E-Cigarette (SREC). Studying the differences between men and women may increase understanding about the effects of switching from smoking regular cigarettes to electronic cigarettes.
Detailed description
PRIMARY OBJECTIVES:
- To characterize the effects of switching to nicotine versus (vs.) placebo standard research E-cigarettes (SRECs) from combustible cigarettes (CCs) on product use, product acceptability, reinforcement, and nicotine dependence symptoms among adult daily CC smokers.
II. To characterize the differences between male and female CC smokers when switching to nicotine versus (vs.) placebo SRECs from CCs on product use, product acceptability, reinforcement, and nicotine dependence symptoms.
EXPLORATORY OBJECTIVE:
- To characterize which factors moderate or mediate the effects of switching to nicotine and placebo SRECs from CCs among male and female CC smokers.
OUTLINE:
Participants will be instructed to smoke their usual brand cigarette as they normally would in weeks 1-2 (Phase I) and to use only the SREC (with or without nicotine) in weeks 3-4 (Phase II) and in weeks 5-6 (Phase III). Participant assignment to SREC type at Phases II and III will be counter-balanced within group, with half of men and women receiving the placebo SREC during Phase II and half during Phase III. Participants will attend 4 laboratory visits with study investigators for 3 hours each over 6 weeks of study participation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-Cig placebo dose followed by E-Cig nicotine dose | Experimental | Drug: Nicotine Replacement, Other: Questionnaire Administration, Device: Electronic CigaretteParticipants will be instructed to smoke their usual brand cigarette as they normally would in weeks 1-2 (Phase I) and to use only the SREC (with or without nicotine) in weeks 3-4 (Phase II) and in weeks 5-6 (Phase III). Participant assignment to SREC type at Phases II and III will be counter-balanced within group, with half of men and women receiving the placebo SREC during Phase II and half during Phase III. Participants will attend 4 laboratory visits with study investigators for 3 hours each over 6 weeks of study participation. |
| E-Cig nicotine dose followed by E-Cig placebo dose | Experimental | Drug: Nicotine Replacement, Other: Questionnaire Administration, Device: Electronic CigaretteParticipants will be instructed to smoke their usual brand cigarette as they normally would in weeks 1-2 (Phase I) and to use only the SREC (with or without nicotine) in weeks 3-4 (Phase II) and in weeks 5-6 (Phase III). Participant assignment to SREC type at Phases II and III will be counter-balanced within group, with half of men and women receiving the placebo SREC during Phase II and half during Phase III. Participants will attend 4 laboratory visits with study investigators for 3 hours each over 6 weeks of study participation. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 21 years or older
- Reports being a daily or non-daily smoker (any self-reported smoking in the past 30 days)
- Have an address where he/she can receive mail
- Able to follow verbal and written instructions in English and complete all aspects of the study as determined by PI
- Willing to have urine biospecimen samples taken, either in-home and returning them by mail, or in-person at an approved collection site.
Key exclusion criteria (6 listed)
- Individuals who report depressive symptoms in the moderately severe or severe range on the PHQ-9 (scores of 15 or above) or who report current suicidal ideation on the PHQ-9
- Uncontrolled or unstable medical condition (e.g., uncontrolled hypertension, angina, diabetes).
- Evidence of cognitive deficits or instability that would preclude reliable study participation.
- Being pregnant, engaging in breast-feeding, or being of childbearing potential and engaging in sexual activity that could lead to pregnancy and is not protected by a medically acceptable, effective method of birth control while enrolled in the study, as determined by self-report. Medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD). Contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use.
- Considered by the investigator to be an unsuitable or unstable candidate (including but not limited to the following situation: unwilling or unable to comply with study procedures)
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 ReplacementAlso: Nicotine Replacement Therapy, NRTReceived NRT (Electronic Cigarette - With Nicotine) | Drug | E-Cig nicotine dose followed by E-Cig placebo dose, E-Cig placebo dose followed by E-Cig nicotine dose |
| Questionnaire AdministrationAncillary studies | Other | E-Cig nicotine dose followed by E-Cig placebo dose, E-Cig placebo dose followed by E-Cig nicotine dose |
| Electronic CigaretteElectronic Cigarette - with Nicotine | Device | E-Cig nicotine dose followed by E-Cig placebo dose, E-Cig placebo dose followed by E-Cig nicotine dose |
| Electronic CigaretteElectronic Cigarette -without Nicotine | Device | E-Cig nicotine dose followed by E-Cig placebo dose, E-Cig placebo dose followed by E-Cig nicotine dose |
Primary outcome
Cigarettes Per Day
Time frame: 2 weeks
Mean cigarettes per day (CPD) smoked during the phase
21 secondary outcomes
Electronic Cigarette Sessions Per Day
Time frame: 2 weeks
Total Nicotine Equivalents (TNE)
Time frame: 2 weeks
Anabasine
Time frame: 2 weeks
Nicotelline
Time frame: 2 weeks
Perceived Health Risk Questionnaire (PHRQ)
Time frame: 2 weeks
Product Evaluation Scales (PES)
Time frame: 2 weeks
Implicit Association Test (IAT)
Time frame: 2 weeks
Brief Smoking Consequences Questionnaire-Adult (BSCQ-A)
Time frame: 2 weeks
Purchase Task Breakpoint Measure
Time frame: 2 weeks
Purchase Task Demand Intensity Measure
Time frame: 2 weeks
Purchase Task Omax Measure
Time frame: 2 weeks
Purchase Task Pmax Measure
Time frame: 2 weeks
Purchase Task Elasticity of Demand Measure
Time frame: 2 weeks
Fagerström Test for Cigarette Dependence (FTCD)
Time frame: 2 weeks
Penn State Electronic Cigarette Dependence Index (PSECDI)
Time frame: 2 weeks
Minnesota Nicotine Withdrawal Scale-Revised (MNWS)
Time frame: 2 weeks
Questionnaire of Smoking Urges-Brief (QSU-Brief)
Time frame: 2 weeks
Positive and Negative Affect Scales - Positive Affect Scale (PANAS-Pos)
Time frame: 2 weeks
Positive and Negative Affect Scales - Negative Affect Scale (PANAS-Neg)
Time frame: 2 weeks
Smartphone Daily Measures of Nicotine Dependence Symptoms
Time frame: 2 weeks
American Thoracic Society Questionnaire (ATSQ)
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41051837Robinson JD, Cui Y, Karam-Hage M, Blalock JA, Shete S, Kypriotakis G, Yang P, Cinciripini PM. Standardized research electronic cigarette acceptability among adult men and women who smoke combustible cigarettes. Psychol Addict Behav. 2025 Dec;39(8):780-791. doi: 10.1037/adb0001100. Epub 2025 Oct 6.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Jason Robinson principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine Replacement, Questionnaire Administration and Electronic Cigarette in people with Cigarette Smoking-Related Carcinoma, run by M.D. Anderson Cancer Center 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 8 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: finished, as of the sponsor's last update on 28 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 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 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?
Cigarettes Per Day (time frame: 2 weeks). 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 NCT03856515, which also lists 1 linked publication.
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 28 Jan 2026.