Methadone-Maintained Smokers Switching to E-Cigarettes

NCT05206435 | Active Not Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: 1702236R01DA052907
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Participants in this randomized clinical trial will be methadone-maintained smokers interested in switching to electronic cigarettes (ECs). There will be a total of 7 study visits over the course of 6 weeks; each visit includes psychometric assessment and biomarker measurements. After completion of the baseline visit, participants will be randomized to either: 1) 6 weeks of EC use (JUUL 5% nicotine pods) or 2) 6 weeks of nicotine replacement therapy (NRT) in the form of nicotine lozenges. EC and NRT use will begin the day after the baseline assessment.

Conditions

Nicotine Dependence; Electronic Cigarette Use

Outcome Measures

Primary Outcomes (10)

• Nicotine Exposure

  Extent of Nicotine Exposure as measured by urine-based tobacco toxicology assessment at baseline and again at 6-weeks.

  6 weeks

• FVC Lung Functioning

  Changes in Forced Vital Capacity (FVC), as measured by spirometry at baseline and again at 6-weeks.

  6 weeks

• FEV1 Lung Functioning

  Changes in Forced Expiratory Volume (FEV - during the first second), as measured by spirometry at baseline and again at 6-weeks.

  6 weeks

• FEV1/FVC Ratio Lung Functioning

  Changes in FEV1/FVC ratio, as measured by spirometry at baseline and again at 6-weeks.

  6 weeks

• Smoking Behavior and Experiences

  Changes in smoking behavior and experiences, as measured by self-report at baseline and again at 6-weeks.

  6 weeks

• Nicotine Exposure for Complete Switchers

  Extent of Nicotine Exposure as measured by urine-based tobacco toxicology assessment at baseline and again at 6-week among complete switchers, irrespective of condition, (i.e., exclusive EC/NRT users based on 7-day carbon monoxide (CO)-verified reports at the 6-week time point) relative to dual users and exclusive CC users.

  6 weeks

• FVC Lung Functioning for Complete Switchers

  Changes in Forced Vital Capacity (FVC), as measured by spirometry at baseline and again at 6-weeks, among complete switchers, irrespective of condition, (i.e., exclusive EC/NRT users based on 7-day carbon monoxide (CO)-verified reports at the 6-week time point) relative to dual users and exclusive CC users.

  6 weeks

• FEV1 Lung Functioning for Complete Switchers

  Changes in Forced Expiratory Volume (FEV - during the first second), as measured by spirometry at baseline and again at 6-weeks, among complete switchers, irrespective of condition, (i.e., exclusive EC/NRT users based on 7-day carbon monoxide (CO)-verified reports at the 6-week time point) relative to dual users and exclusive CC users.

  6 weeks

• FEV1/FVC Ratio Lung Functioning for Complete Switchers

  Changes in FEV1/FVC ratio, as measured by spirometry at baseline and again at 6-weeks, among complete switchers, irrespective of condition, (i.e., exclusive EC/NRT users based on 7-day carbon monoxide (CO)-verified reports at the 6-week time point) relative to dual users and exclusive CC users.

  6 weeks

• Smoking Behavior and Experiences for Complete Switchers

  Changes in smoking behavior and experiences, as measured by self-report at baseline and again at 6-weeks, among complete switchers, irrespective of condition, (i.e., exclusive EC/NRT users based on 7-day carbon monoxide (CO)-verified reports at the 6-week time point) relative to dual users and exclusive CC users.

  6 weeks

Study Arms (2)

Electronic Cigarettes

ACTIVE COMPARATOR

Participants in this arm are randomized to receive electronic cigarettes for the 6-week study period.

Drug: Electronic Cigarette

Nicotine Lozenges

ACTIVE COMPARATOR

Participants in this arm are randomized to receive nicotine lozenge for the 6-week study period.

Drug: Nicotine Lozenge

Interventions

Electronic Cigarette DRUG

Electronic Cigarettes are provided to replace tobacco cigarettes

Electronic Cigarettes

Nicotine Lozenge DRUG

Nicotine Lozenges are provided to replace tobacco cigarettes

Nicotine Lozenges

Eligibility Criteria

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

You may qualify if:

• moderate to heavy cigarette smokers (10 cigarettes/day for \> 1 yr; breath CO \> 10 ppm)
• have been receiving methadone for at least three months
• attend at least weekly to receive methadone dose
• speak English
• have a telephone or access to a telephone
• are available over the next 6 weeks
• are interested in switching to either electronic cigarettes or nicotine replacement therapy

You may not qualify if:

• use of ECs on \> 2 of the past 30 days
• currently use medications that may reduce smoking (e.g., bupropion, varenicline, NRT)
• have unstable psychiatric conditions
• have near-daily or daily use of marijuana
• are pregnant
• had a cardiovascular event in the last month
• daily medication for asthma or COPD

Sponsors & Collaborators

• Butler Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Vaping

Interventions

Electronic Nicotine Delivery Systems; Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 25, 2022
• Study Start: March 31, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)