Impact of E-cigarette Characteristics on Reinforcement and Tobacco Use Patterns

NCT03844672 | Completed Results

• 2 other identifiers: 00081069K01DA047433
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to understand how different e-cigarettes influence their likeability and use among current smokers who try using e-cigarettes. Participants will receive an e-cigarette to sample over a three week period. During this time period they will complete daily electronic diaries and weekly lab visits. The results from this information will help understand how different types of e-cigarettes are likely to influence cigarette and e-cigarette use.

Conditions

Smoking; Tobacco Use

Outcome Measures

Primary Outcomes (1)

• Mean Cigarettes Per Day

  Participants complete weekly surveys reporting the number of cigarettes smoked each day on a continuous scale

  Week 3

Secondary Outcomes (2)

• Average Number of E-cigarette Puffing Episodes

  Week 3

• Number of Choices to Smoke Cigarette in Lab Setting

  Week 3

Study Arms (4)

Low Concentration / Low Power

EXPERIMENTAL

Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a low power for three weeks.

Behavioral: Low Power; Behavioral: Low Concentration

Low Concentration / High Power

EXPERIMENTAL

Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a high power for three weeks.

Behavioral: High Power; Behavioral: Low Concentration

High Concentration / Low Power

EXPERIMENTAL

Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a low power for three weeks.

Behavioral: Low Power; Behavioral: High Concentration

High Concentration / High Power

EXPERIMENTAL

Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a high power for three weeks.

Behavioral: High Power; Behavioral: High Concentration

Interventions

Low Power BEHAVIORAL

Participants will receive a low power e-cigarette to use for 3 weeks

High Concentration / Low Power; Low Concentration / Low Power

High Power BEHAVIORAL

Participants will receive a high power e-cigarette to use for 3 weeks

High Concentration / High Power; Low Concentration / High Power

Low Concentration BEHAVIORAL

Participants will receive a low concentration e-liquid to use for 3 weeks

Low Concentration / High Power; Low Concentration / Low Power

High Concentration BEHAVIORAL

Participants will receive a high concentration e-liquid to use for 3 weeks

High Concentration / High Power; High Concentration / Low Power

Eligibility Criteria

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

You may qualify if:

• adults who have been smoking daily
• interested in using e-cigarettes
• who have a smartphone that can receive text messages and access to the internet or has an e-mail account that they check daily

You may not qualify if:

• minimal prior e-cigarette use
• use of tobacco products other than cigarettes
• current use of cessation medications
• pregnant, trying to become pregnant, or breastfeeding,
• recent history of cardiovascular distress in the last three months (e.g., arrhythmia, heart attack, stroke, uncontrolled hypertension),
• household member currently enrolled in the study.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Smoking; Tobacco Use

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Results Point of Contact

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

smithtra@musc.edu

8437925164

Study Officials

• Tracy Smith, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 18, 2019
• Study Start: April 1, 2019
• Primary Completion: October 17, 2023
• Study Completion: November 9, 2023
• Last Updated: October 24, 2024
• Results First Posted: October 24, 2024

Record last verified: 2024-10

Locations

US (1)