Smoking, CigaretteNCT05327439
Using ANDS to Reduce Harm for Low SES Cigarette Smokers
A study testing Nicotine (electronic cigarette) and Nicotine (nicotine pouch) in people with Smoking, Cigarette and Nicotine Dependence, run by Brown University at 1 site in United States.
Trial summary
This study investigates whether providing 8 weeks of complimentary electronic cigarettes (EC) or nicotine pouches (NP) to low socioeconomic status (SES) adults who smoke and are unable or unwilling to quit smoking will lead to: a) substitution of cigarette smoking with EC or NP; and b) reduced biological indicators of… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Smoking, Cigarette, Nicotine Dependence
- What is being tested?
- Nicotine (electronic cigarette) and Nicotine (nicotine pouch)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2022to 9 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 (inclusive) years of age or greater
- Past 6 months daily smoking of ≥ 5 cigarettes/day
- Exhaled CO ≥ 6 ppm at baseline
- Household income < 250% federal poverty level (FPL)
- Willingness to substitute combustible cigarettes for EC or NPs
- Ability to read and write in English
- Own a telephone (landline or cellphone)
Who cannot join
- Intention to quit smoking during the next 30 days
- Current or past 30 day engagement in smoking cessation
- Current use of EC or NP ≥ 4 days per month
- Current self-report of primarily using tobacco products that are not combustible cigarettes
- Urine-screened pregnancy
- Hospitalization for a psychiatric issue in the past 30 days or visible instability
Show all 11Show fewer
- Other household member is a study participant
- Participating in another clinical trial at the same time
- Heart-related event in the past 30 days
- Planning to move out of the Providence area in the next six months
- Note: Cannabis use will be assessed but not excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Alcohol and Addiction Studies, Brown University School of Public Health
Providence, Rhode Island, 02912
About this study
Official title: Using Alternative Nicotine Delivery Systems (ANDS) to Reduce Harm for Low SES Cigarette Smokers. (Tri-PEC Study)
This study investigates whether providing 8 weeks of complimentary electronic cigarettes (EC) or nicotine pouches (NP) to low socioeconomic status (SES) adults who smoke and are unable or unwilling to quit smoking will lead to: a) substitution of cigarette smoking with EC or NP; and b) reduced biological indicators of tobacco use and harm relative to those continuing to smoke as usual. This study also examines the feasibility and acceptability of providing EC or NP to help substitution of combustible cigarettes, exploring willingness to participate, continuing with the study, and barriers to substitution through interviews. This project will enroll 45 low SES adults who smoke and will be randomized to one of the three groups that will be followed for 8 weeks: EC, NP, or smoking as usual.
The first study hypothesis is that participants receiving EC or NP will smoke fewer cigarettes per day and have lower cigarette dependence at Week 8 relative to their baseline level, and when compared to the control group. The second hypothesis is that those in the EC or NP group will have greater cigarette abstinence than those smoking as usual at Week 8. There are no anticipated differences between those receiving EC and NP. The third hypothesis is that biological indicators of tobacco use and harm will be lower in those receiving EC or NP relative to their baseline level, and when compared to the control group. The hypothesis is that these biological indicators will be lower in those receiving NP than EC.
Read the detailed description
This study investigates whether providing 8 weeks of complimentary electronic cigarettes (EC) or nicotine pouches (NP) to low socioeconomic status (SES) adults who smoke and are unable or unwilling to quit smoking will lead to: a) substitution of cigarette smoking with EC or NP; and b) reduced biological indicators of tobacco use and harm relative to those continuing to smoke as usual. This study also examines the feasibility and acceptability of providing EC or NP to help substitution of combustible cigarettes, exploring willingness to participate, continuing with the study, and barriers to substitution through interviews. This project will enroll 45 low SES adults who smoke and will be randomized to one of the three groups that will be followed for 8 weeks: EC, NP, or smoking as usual. At the start of the study, participants will provide informed consent; biological indicators and self-report measures will be collected; and participants will be randomly assigned to one of the 3 groups. Participants in the EC or NP groups will be allowed to experiment with EC or NP flavors prior to receiving an adequate supply of the product to fully substitute combustible smoking for four weeks. Participants in these two groups will also receive encouragement to fully switch from cigarettes to EC or NP. Participants will have 3 in-person visits (baseline, week 4, week 8) and 4 phone visits (weeks 1, 3, 7, and 16). At the week 4 in-person visit, participants will receive a second four-week product supply. Participants will also receive ongoing encouragement to fully substitute with EC or NPs whenever participants would normally smoke. Biomarkers and self-report measures will be reassessed at the Week 8 visit after which participants will complete a debriefing interview. Participants will complete a final report at Week 16.
The first study hypothesis is that participants receiving EC or NP will smoke fewer cigarettes per day and have lower cigarette dependence at Week 8 relative to their baseline level, and when compared to the control group. The second hypothesis is that those in the EC or NP group will have greater cigarette abstinence than those smoking as usual at Week 8. There are no anticipated differences between those receiving EC and NP. The third hypothesis is that biological indicators of tobacco use and harm will be lower in those receiving EC or NP relative to their baseline level, and when compared to the control group. The hypothesis is that these biological indicators will be lower in those receiving NP than EC.
- Conditions
- Smoking, Cigarette, Nicotine Dependence
- Being tested
- Nicotine (electronic cigarette), Nicotine (nicotine pouch)
- Keywords
- cigarette substitution, electronic nicotine delivery systems, ENDS, e-cigarette, nicotine pouch, nicotine dependence, low SES, smoking
- Medical subject headings
- Cigarette Smoking, Tobacco Use Disorder, Vaping, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine (electronic cigarette)Other
Participants will be provided with electronic cigarettes and 5% nicotine e-liquid cartridges for 8 weeks and encouraged at in-person and phone assessments to use the electronic cigarette any time they would normally smoke. Participants will be able to choose one of two e-liquid flavors (tobacco, menthol) at baseline.
Nicotine (nicotine pouch)Other
Participants will be provided with 4mg nicotine pouches for 8 weeks and encouraged at in-person and phone assessments to use the nicotine pouches any time they would normally smoke. Participants will be able to choose one of two nicotine pouch flavors (tobacco, mint) at baseline.
| Study group | Role | What they receive |
|---|---|---|
| Electronic Cigarette | Experimental | Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges. Receives: Other: Nicotine (electronic cigarette) |
| Nicotine Pouch | Experimental | Participants in this experimental condition will be provided with nicotine pouches. Receives: Other: Nicotine (nicotine pouch) |
| Smoking As Usual | No intervention | Participants in this assessment-only condition will continue smoking as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cigarettes per day from baseline to week 8
Within and between group difference in past week average cigarettes per day assessed using timeline follow-back (TLFB)
Measured: Assessed at baseline and week 8.
Change in cigarette dependence from baseline to week 8
Change in cigarette dependence within group and between groups. Assessed using the Strong et al measure adapted from the Population Assessment of Tobacco and Health survey
Measured: Assessed at baseline and week 8.
Cigarette abstinence at week 8
Past week any-use of cigarettes assessed using timeline follow-back (TLFB).
Measured: Week 8.
Secondary outcomes (5)
Change in Carbon monoxide from baseline to week 8
Exhaled carbon monoxide assessed via Smokerlyzer and compared within group and between groups.
Measured: Assessed at baseline and week 8.
Change in cotinine from baseline to week 8
Creatinine-adjusted cotinine assessed via urine compared within group and between groups.
Measured: Assessed at baseline and week 8.
Change in NNAL from baseline to week 8
4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), a ratio of NNAL to creatinine-adjusted cotinine assessed via urine and compared within group and between groups.
Measured: Assessed at baseline and week 8.
Change in 8-isoprostane from baseline to week 8
8-isoprostane assessed via urine and compared within group and between groups
Measured: Assessed at baseline and week 8.
Feasibility and acceptability
Willingness to participate as measured by proportion of eligible participants following in-person screening who enroll in the study. Retention as measured by weeks of study participation. Barriers to substitution as indicated in qualitative exit interview.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start23 Mar 2022
- Primary completion15 Dec 2022
- Study completion9 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking, CigaretteStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jasjit S Ahluwalia, MD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327439
- Sponsor's protocol ID
- 2105002986
- Status last verified
- Jan 2023
- First submitted
- 27 Aug 2021
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified study data except for transcriptions of qualitative interviews will be made available after the completion of all study activities.
Publications
Avila JC, Maglalang DD, Nollen NL, Lee SC, Suh R, Malone M, Binjrajka U, Ahluwalia JS. Using Pod Based e-Cigarettes and Nicotine Pouches to Reduce Harm for Adults With Low Socioeconomic Status Who Smoke: A Pilot Randomized Controlled Trial. Nicotine Tob Res. 2024 Aug 22;26(9):1150-1158. doi: 10.1093/ntr/ntae047.
PubMed 38447095
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Alternative Nicotine Delivery Systems (ANDS) to Reduce Harm for Low SES Cigarette Smokers. (Tri-PEC Study)
- ClinicalTrials.gov ID
- NCT05327439
- Acronym / sponsor ID
- 2105002986
- Conditions
- Smoking, Cigarette, Nicotine Dependence
- Keywords
- cigarette substitution, electronic nicotine delivery systems, ENDS, e-cigarette, nicotine pouch, nicotine dependence, low SES, smoking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 9 Feb 2023 (estimated)
- First posted
- 14 Apr 2022 (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.
This study investigates whether providing 8 weeks of complimentary electronic cigarettes (EC) or nicotine pouches (NP) to low socioeconomic status (SES) adults who smoke and are unable or unwilling to quit smoking will lead to: a) substitution of cigarette smoking with EC or NP; and b) reduced biological indicators of tobacco use and harm relative to those continuing to smoke as usual. This study also examines the feasibility and acceptability of providing EC or NP to help substitution of combustible cigarettes, exploring willingness to participate, continuing with the study, and barriers to substitution through interviews. This project will enroll 45 low SES adults who smoke and will be randomized to one of the three groups that will be followed for 8 weeks: EC, NP, or smoking as usual.
The first study hypothesis is that participants receiving EC or NP will smoke fewer cigarettes per day and have lower cigarette dependence at Week 8 relative to their baseline level, and when compared to the control group. The second hypothesis is that those in the EC or NP group will have greater cigarette abstinence than those smoking as usual at Week 8. There are no anticipated differences between those receiving EC and NP. The third hypothesis is that biological indicators of tobacco use and harm will be lower in those receiving EC or NP relative to their baseline level, and when compared to the control group. The hypothesis is that these biological indicators will be lower in those receiving NP than EC.
Detailed description
This study investigates whether providing 8 weeks of complimentary electronic cigarettes (EC) or nicotine pouches (NP) to low socioeconomic status (SES) adults who smoke and are unable or unwilling to quit smoking will lead to: a) substitution of cigarette smoking with EC or NP; and b) reduced biological indicators of tobacco use and harm relative to those continuing to smoke as usual. This study also examines the feasibility and acceptability of providing EC or NP to help substitution of combustible cigarettes, exploring willingness to participate, continuing with the study, and barriers to substitution through interviews. This project will enroll 45 low SES adults who smoke and will be randomized to one of the three groups that will be followed for 8 weeks: EC, NP, or smoking as usual. At the start of the study, participants will provide informed consent; biological indicators and self-report measures will be collected; and participants will be randomly assigned to one of the 3 groups. Participants in the EC or NP groups will be allowed to experiment with EC or NP flavors prior to receiving an adequate supply of the product to fully substitute combustible smoking for four weeks. Participants in these two groups will also receive encouragement to fully switch from cigarettes to EC or NP. Participants will have 3 in-person visits (baseline, week 4, week 8) and 4 phone visits (weeks 1, 3, 7, and 16). At the week 4 in-person visit, participants will receive a second four-week product supply. Participants will also receive ongoing encouragement to fully substitute with EC or NPs whenever participants would normally smoke. Biomarkers and self-report measures will be reassessed at the Week 8 visit after which participants will complete a debriefing interview. Participants will complete a final report at Week 16.
The first study hypothesis is that participants receiving EC or NP will smoke fewer cigarettes per day and have lower cigarette dependence at Week 8 relative to their baseline level, and when compared to the control group. The second hypothesis is that those in the EC or NP group will have greater cigarette abstinence than those smoking as usual at Week 8. There are no anticipated differences between those receiving EC and NP. The third hypothesis is that biological indicators of tobacco use and harm will be lower in those receiving EC or NP relative to their baseline level, and when compared to the control group. The hypothesis is that these biological indicators will be lower in those receiving NP than EC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Electronic Cigarette | Experimental | Other: Nicotine (electronic cigarette)Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges. |
| Nicotine Pouch | Experimental | Other: Nicotine (nicotine pouch)Participants in this experimental condition will be provided with nicotine pouches. |
| Smoking As Usual | No intervention | –Participants in this assessment-only condition will continue smoking as usual. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 21 (inclusive) years of age or greater
- Past 6 months daily smoking of ≥ 5 cigarettes/day
- Exhaled CO ≥ 6 ppm at baseline
- Household income < 250% federal poverty level (FPL)
- Willingness to substitute combustible cigarettes for EC or NPs
Key exclusion criteria (11 listed)
- Intention to quit smoking during the next 30 days
- Current or past 30 day engagement in smoking cessation
- Current use of EC or NP ≥ 4 days per month
- Current self-report of primarily using tobacco products that are not combustible cigarettes
- Urine-screened pregnancy
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 (electronic cigarette)Participants will be provided with electronic cigarettes and 5% nicotine e-liquid cartridges for 8 weeks and encouraged at in-person and phone assessments to use the electronic cigarette any time they would normally smoke. Participants will be able to choose one of two e-liquid flavors (tobacco, menthol) at baseline. | Other | Electronic Cigarette |
| Nicotine (nicotine pouch)Participants will be provided with 4mg nicotine pouches for 8 weeks and encouraged at in-person and phone assessments to use the nicotine pouches any time they would normally smoke. Participants will be able to choose one of two nicotine pouch flavors (tobacco, mint) at baseline. | Other | Nicotine Pouch |
Primary outcome
Change in cigarettes per day from baseline to week 8
Time frame: Assessed at baseline and week 8.
Within and between group difference in past week average cigarettes per day assessed using timeline follow-back (TLFB)
Change in cigarette dependence from baseline to week 8
Time frame: Assessed at baseline and week 8.
Change in cigarette dependence within group and between groups. Assessed using the Strong et al measure adapted from the Population Assessment of Tobacco and Health survey
Cigarette abstinence at week 8
Time frame: Week 8.
Past week any-use of cigarettes assessed using timeline follow-back (TLFB).
5 secondary outcomes
Change in Carbon monoxide from baseline to week 8
Time frame: Assessed at baseline and week 8.
Change in cotinine from baseline to week 8
Time frame: Assessed at baseline and week 8.
Change in NNAL from baseline to week 8
Time frame: Assessed at baseline and week 8.
Change in 8-isoprostane from baseline to week 8
Time frame: Assessed at baseline and week 8.
Feasibility and acceptability
Time frame: through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Derived from this study: PubMed 38447095Avila JC, Maglalang DD, Nollen NL, Lee SC, Suh R, Malone M, Binjrajka U, Ahluwalia JS. Using Pod Based e-Cigarettes and Nicotine Pouches to Reduce Harm for Adults With Low Socioeconomic Status Who Smoke: A Pilot Randomized Controlled Trial. Nicotine Tob Res. 2024 Aug 22;26(9):1150-1158. doi: 10.1093/ntr/ntae047.
- Individual participant dataSharing planned: Yes. Deidentified study data except for transcriptions of qualitative interviews will be made available after the completion of all study activities.
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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.
Jasjit S Ahluwalia, MD principal investigator
Brown University
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 (electronic cigarette) and Nicotine (nicotine pouch) in people with Smoking, Cigarette and Nicotine Dependence, run by Brown University 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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 26 Jan 2023. 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?
Results are not available in the source record.
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 cigarettes per day from baseline to week 8 (time frame: Assessed at baseline and week 8.). 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?
On the ClinicalTrials.gov record for NCT05327439, 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 26 Jan 2023.