Using ANDS to Reduce Harm for Low SES Cigarette Smokers

NCT05327439 | Unknown

• 1 other identifier: 2105002986
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking, Cigarette; Nicotine Dependence

Keywords

cigarette substitution; electronic nicotine delivery systems; ENDS; e-cigarette; nicotine pouch; nicotine dependence; low SES; smoking

Outcome Measures

Primary Outcomes (3)

• 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)

  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

  Assessed at baseline and week 8.

• Cigarette abstinence at week 8

  Past week any-use of cigarettes assessed using timeline follow-back (TLFB).

  Week 8.

Secondary Outcomes (5)

• Change in Carbon monoxide from baseline to week 8

  Assessed at baseline and week 8.

• Change in cotinine from baseline to week 8

  Assessed at baseline and week 8.

• Change in NNAL from baseline to week 8

  Assessed at baseline and week 8.

• Change in 8-isoprostane from baseline to week 8

  Assessed at baseline and week 8.

• Feasibility and acceptability

  through study completion, an average of 6 months

Study Arms (3)

Electronic Cigarette

EXPERIMENTAL

Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges.

Other: Nicotine (electronic cigarette)

Nicotine Pouch

EXPERIMENTAL

Participants in this experimental condition will be provided with nicotine pouches.

Other: Nicotine (nicotine pouch)

Smoking As Usual

NO INTERVENTION

Participants in this assessment-only condition will continue smoking as usual.

Interventions

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.

Electronic Cigarette

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.

Nicotine Pouch

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Brown University: lead

Study Sites (1)

Center for Alcohol and Addiction Studies, Brown University School of Public Health

Providence, Rhode Island, 02912, United States

Location

Related Publications (1)

• 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.

  PMID: 38447095 DERIVED

MeSH Terms

Conditions

Cigarette Smoking; Tobacco Use Disorder; Vaping; Smoking

Interventions

Nicotine; Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Jasjit S Ahluwalia, MD

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: April 14, 2022
• Study Start: March 23, 2022
• Primary Completion: December 15, 2022
• Study Completion: February 9, 2023
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: After closing the study IRB protocol and destroying all identifiers. Anticipated 2 years after completion of primary data collection. Data availability will be perpetual. Data dissemination plan is pending.

Locations

US (1)