JUUL vs. Mod E-cigarette Study

NCT04237272 | Completed Results

• 2 other identifiers: Pro00089701P30CA138313
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Some smokers who try e-cigarettes transition completely from cigarettes to e-cigarettes, but others continue to use both products, or abandon e-cigarettes and return completely to cigarettes. One factor that likely impacts these tobacco use patterns is the e-cigarette device used. The majority of e-cigarettes purchased today are one of two "types:" customizable tanks or pods. These e-cigarette types differ from each other in critical ways, like nicotine delivery and sensory characteristics, that are likely to impact use by influencing the relative reinforcement value of the product. The present study will be a randomized trial investigating the impact of e-cigarette device type on reinforcement value and use among current smokers. Current smokers (n=100) will be randomly assigned to either a control group that does not receive an e-cigarette or one of two e-cigarette types: a customizable tank, or a pod. The impact of device type on relative reinforcement value will be assessed using a choice task. Participants will also take home their assigned e-cigarette for a three-week sampling period. Primary outcomes include relative reinforcement value (choices to smoke in the lab-based choice task), cigarette smoking behavior (cigarettes smoked per day during sampling), and uptake (e-cigarette puffing episodes per day during sampling).

Conditions

Smoking; Tobacco Use

Outcome Measures

Primary Outcomes (1)

• Choices to Smoke

  The percentage of choices to smoke the conventional cigarette at the Week 3 visit. Participants chose between smoking a conventional cigarette, using their assigned e-cigarette, and not using any tobacco product. Participants made the choice 10 times. Outcome is calculated as = ((number of choices to smoke / 10)\*100)

  Week 3 visit

Secondary Outcomes (1)

• Average Cigarettes Per Day

  Week 3

Study Arms (3)

Pod System

ACTIVE COMPARATOR

Participants assigned to this intervention will try to pod system e-cigarette in the lab and receive a pod system e-cigarette to use for a three week sampling period.

Other: Pod System E-cig

Customizable Tank

ACTIVE COMPARATOR

Participants assigned to this intervention will try to customizable tank system e-cigarette in the lab and receive a customizable tank system e-cigarette to use for a three week sampling period.

Other: Customizable Tank E-cig

Control

ACTIVE COMPARATOR

Participants assigned to this arm will not receive any e-cigarette

Other: Control

Interventions

Pod System E-cig OTHER

Participants assigned to this intervention will try to pod system e-cigarette in the lab and receive a pod system e-cigarette to use for a three week sampling period.

Pod System

Customizable Tank E-cig OTHER

Participants assigned to this intervention will try to customizable tank system e-cigarette in the lab and receive a customizable tank system e-cigarette to use for a three week

Customizable Tank

Control OTHER

Participants will not receive any e-cigarette

Control

Eligibility Criteria

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

You may qualify if:

• daily smoker
• interested in using e-cigs
• have a smartphone that can receive text messages and has access to the internet or have an e-mail account they check daily (necessary for daily diary completion)
• be at least 21 years of age

You may not qualify if:

• additional tobacco use criteria
• additional medical criteria

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Smoking; Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. Tracy Smith
• Organization: Medical University of South Carolina

smithtra@musc.edu

843 792 5164

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 23, 2020
• Study Start: November 15, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 24, 2021
• Last Updated: December 21, 2022
• Results First Posted: December 21, 2022

Record last verified: 2022-11

Locations

US (1)