The Impact of E-liquid Nicotine Content on Reinforcement in Current Smokers

NCT03186911 | Withdrawn

• 2 other identifiers: U54 DA031659-06 Pilot1U54DA031659-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Participants will complete a phone screen and then one laboratory session. After completing in-person screening assessments, eligible participants will complete additional questionnaires. Participants will then choose an e-liquid flavor to use for the rest of the session. Participants will then sample two e-liquids that vary in nicotine content from little or no nicotine to a moderate level of nicotine, and questionnaires evaluating the subjective effects of each one. Participants will then complete a preference assessment where they choose between the two e-liquids. Participants will be blind to the nicotine contents.

Conditions

Tobacco Use

Outcome Measures

Primary Outcomes (1)

• Product Evaluation Questionnaire

  Ratings of the two e-liquids on a self-report questionnaire

  One Day

Secondary Outcomes (3)

• Preference Assessment

  One Day

• Perceived Health Risk Questionnaire

  One Day

• Vaping Purchase Task

  One Day

Study Arms (1)

E-liquid Group

OTHER

Participants will sample two different e-liquids.

Behavioral: E-liquid sampling and preference assessment

Interventions

E-liquid sampling and preference assessment BEHAVIORAL

Participants will sample two different e-liquids that vary in nicotine content, complete questionnaires about each one, and then choose between the two e-liquids in a preference assessment task.

E-liquid Group

Eligibility Criteria

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

You may qualify if:

• At least 18 years old
• Daily cigarette smoking
• Have tried vaping devices on a minimum of one lifetime occasion

You may not qualify if:

• Unwilling to use a vaping device during the session
• Break alcohol level \> 0.01 (g/dL)
• Pregnant, trying to become pregnant, or breastfeeding
• Systolic BP greater than or equal to 160 mm/Hg or below 90 mm/Hg
• Diastolic BP greater than or equal to 100 mm/Hg or below 50 mm/Hg
• Heart rate greater than or equal to 105 bpm or lower than 45 bpm
• A current upper respiratory infection, recent cardiac event (in the last year), Buerger disease, irregular heartbeat or arrhythmia within the last year, previous allergic or adverse reaction to nicotine

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Eric C Donny, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 14, 2017
• Study Start: July 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: August 5, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share