Using ANDS to Reduce Harm for Low SES Cigarette Smokers

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Brown University

Status

Active, not recruiting

Conditions

Smoking, Cigarette
Nicotine Dependence

Treatments

Other: Nicotine (nicotine pouch)
Other: Nicotine (electronic cigarette)

Study type

Interventional

Funder types

Other

Identifiers

NCT05327439
2105002986

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age 21 (inclusive) years of age or greater
  2. Past 6 months daily smoking of ≥ 5 cigarettes/day
  3. Exhaled CO ≥ 6 ppm at baseline
  4. Household income < 250% federal poverty level (FPL)
  5. Willingness to substitute combustible cigarettes for EC or NPs
  6. Ability to read and write in English
  7. Own a telephone (landline or cellphone)

Exclusion criteria

  1. Intention to quit smoking during the next 30 days
  2. Current or past 30 day engagement in smoking cessation
  3. Current use of EC or NP ≥ 4 days per month
  4. Current self-report of primarily using tobacco products that are not combustible cigarettes
  5. Urine-screened pregnancy
  6. Hospitalization for a psychiatric issue in the past 30 days or visible instability
  7. Other household member is a study participant
  8. Participating in another clinical trial at the same time
  9. Heart-related event in the past 30 days
  10. Planning to move out of the Providence area in the next six months

Note: Cannabis use will be assessed but not excluded

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

45 participants in 3 patient groups

Electronic Cigarette
Experimental group
Description:
Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges.
Treatment:
Other: Nicotine (electronic cigarette)
Nicotine Pouch
Experimental group
Description:
Participants in this experimental condition will be provided with nicotine pouches.
Treatment:
Other: Nicotine (nicotine pouch)
Smoking As Usual
No Intervention group
Description:
Participants in this assessment-only condition will continue smoking as usual.

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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