E-cigarette Nicotine Study

NCT04709471 | Completed Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: STUDY00001093
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot randomized controlled trial (RCT) with the overarching aim of testing the influence of reducing electronic nicotine delivery system (ENDS) use or nicotine on addiction and combustible cigarette (CC) smoking among dual users. Specifically, the investigators will conduct a 4-week pilot RCT in which dual users who are not motivated to quit either product in the near future are randomized to A) abruptly switch to low nicotine ENDS pods, B) abruptly reduce number of usual nicotine ENDS pods, or C) use ENDS as usual (control). The investigators adapted a protocol used in a prior study to assign participants to switch to ENDS pods with less nicotine or reduce number of ENDS pods in this trial. Specifically, the investigators will provide all participants with ENDS pods during the study period and instruct them to only use ENDS provided by the study. Participants in reduced nicotine condition will switch from usual nicotine (5% JUUL) to low nicotine ENDS (3% nicotine JUUL) pods. Participants in the reduced use condition will continue to use usual nicotine ENDS (5% nicotine JUUL) pods but reduce use to 60% of their baseline number of pods per week. Participants in the control condition will use usual nicotine ENDS (5% nicotine JUUL) pods as usual.

Conditions

Nicotine Dependence; Electronic Cigarette Use; Cigarette Smoking

Keywords

Cigarettes; Electronic nicotine delivery systems; Electronic cigarettes

Outcome Measures

Primary Outcomes (4)

• Feasibility

  The investigators will assess compliance with study e-cigarettes and compare the percent non-study e-cigarette use between conditions to determine which behavior-changing strategy is more feasible.

  Baseline and the four week reduction period

• Combustible cigarette smoking

  The investigators will compare change in number of cigarettes per day between conditions.

  Baseline and the four week reduction period

• Cigarette dependence

  The investigators will compare change in cigarette dependence between conditions using the PATH dependence measure.

  Baseline and the four week reduction period

• E-cigarette dependence

  The investigators will compare change in e-cigarette dependence between conditions using the PATH dependence measure.

  Baseline and the four week reduction period

Secondary Outcomes (2)

• Cigarette demand

  Baseline and the four week reduction period

• E-cigarette demand

  Baseline and the four week reduction period

Study Arms (3)

Switch to low nicotine e-cigarettes

EXPERIMENTAL

Switch to e-cigarettes containing 60% of baseline e-cigarette nicotine content.

Drug: Nicotine; Device: Juul e-cigarette

Reduce number of e-cigarette pods

EXPERIMENTAL

Reduce e-cigarette use to 60% of baseline number of pods per week.

Drug: Nicotine; Behavioral: Reduction

Use e-cigarettes as usual

NO INTERVENTION

Continue using usual nicotine e-cigarettes as usual.

Interventions

Nicotine DRUG

Participants will reduce their nicotine intake

Reduce number of e-cigarette pods; Switch to low nicotine e-cigarettes

Juul e-cigarette DEVICE

Participants will switch to Juul pods containing less nicotine

Switch to low nicotine e-cigarettes

Reduction BEHAVIORAL

Participants will reduce the number of Juul pods that they use

Reduce number of e-cigarette pods

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Eligibility criteria include at least 21 years old, use e-cigarettes and tobacco cigarettes regularly, not planning to quit in the near future, and not pregnant, breastfeeding or planning to become pregnant or breastfeed in the next 2 months. Additional criteria will be evaluated to assess for eligibility.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Vaping; Cigarette Smoking

Interventions

Nicotine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 14, 2021
• Study Start: January 20, 2021
• Primary Completion: April 26, 2022
• Study Completion: June 1, 2022
• Last Updated: August 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)