Clinical trial NCT05327439: Using ANDS to Reduce Harm for Low SES Cigarette Smokers
Official title: Using Alternative Nicotine Delivery Systems (ANDS) to Reduce Harm for Low SES Cigarette Smokers. (Tri-PEC Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking, Cigarette
Nicotine Dependence
Keywords: cigarette substitution
electronic nicotine delivery systems
ENDS
e-cigarette
nicotine pouch
nicotine dependence
low SES
smoking
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in cigarettes per day from baseline to week 8
timeFrame: Assessed at baseline and week 8.
measure: Change in cigarette dependence from baseline to week 8
timeFrame: Assessed at baseline and week 8.
measure: Cigarette abstinence at week 8
timeFrame: Week 8.
Secondary outcomes:
measure: Change in Carbon monoxide from baseline to week 8
timeFrame: Assessed at baseline and week 8.
measure: Change in cotinine from baseline to week 8
timeFrame: Assessed at baseline and week 8.
measure: Change in NNAL from baseline to week 8
timeFrame: Assessed at baseline and week 8.
measure: Change in 8-isoprostane from baseline to week 8
timeFrame: Assessed at baseline and week 8.
measure: Feasibility and acceptability
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Center for Alcohol and Addiction Studies, Brown University School of Public Health
state: Rhode Island
Study officials:
affiliation: Brown University
name: Jasjit S Ahluwalia, MD
role: PRINCIPAL_INVESTIGATOR
References: