- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05327439
Using ANDS to Reduce Harm for Low SES Cigarette Smokers
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jasjit S Ahluwalia, MD
- Phone Number: 401-863-6654
- Email: jasjit_ahluwalia@brown.edu
Study Contact Backup
- Name: Jaqueline Contrera Avila, PhD
- Phone Number: 401-863-3901
- Email: jaqueline_avila@brown.edu
Study Locations
-
-
Rhode Island
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Providence, Rhode Island, United States, 02912
- Center for Alcohol and Addiction Studies, Brown University School of Public Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Electronic Cigarette
Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges.
|
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.
|
Experimental: Nicotine Pouch
Participants in this experimental condition will be provided with nicotine pouches.
|
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.
|
No Intervention: Smoking As Usual
Participants in this assessment-only condition will continue smoking as usual.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Assessed at baseline and week 8.
|
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
|
Assessed at baseline and week 8.
|
Cigarette abstinence at week 8
Time Frame: Week 8.
|
Past week any-use of cigarettes assessed using timeline follow-back (TLFB).
|
Week 8.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Carbon monoxide from baseline to week 8
Time Frame: Assessed at baseline and week 8.
|
Exhaled carbon monoxide assessed via Smokerlyzer and compared within group and between groups.
|
Assessed at baseline and week 8.
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Change in cotinine from baseline to week 8
Time Frame: Assessed at baseline and week 8.
|
Creatinine-adjusted cotinine assessed via urine compared within group and between groups.
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Assessed at baseline and week 8.
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Change in NNAL from baseline to week 8
Time Frame: Assessed at baseline and 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.
|
Assessed at baseline and week 8.
|
Change in 8-isoprostane from baseline to week 8
Time Frame: Assessed at baseline and week 8.
|
8-isoprostane assessed via urine and compared within group and between groups
|
Assessed at baseline and week 8.
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Feasibility and acceptability
Time Frame: through study completion, an average of 6 months
|
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.
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through study completion, an average of 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jasjit S Ahluwalia, MD, Brown University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Tobacco Use Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Nicotine
Other Study ID Numbers
- 2105002986
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- Study Protocol
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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