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

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.

Study Overview

• Status: Withdrawn
• Conditions: Tobacco Use
• Intervention / Treatment: Behavioral: E-liquid sampling and preference assessment

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: E-liquid Group; Participants will sample two different e-liquids.	Behavioral: E-liquid sampling and preference assessment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Product Evaluation Questionnaire	Ratings of the two e-liquids on a self-report questionnaire	One Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preference Assessment	Choices of each of the two e-liquids on a preference assessment	One Day
Perceived Health Risk Questionnaire	Personal Health Risk Ratings about each of the two e-liquids	One Day
Vaping Purchase Task	Hypothetical estimates of consumption of each of the e-liquids across a variety of prices	One Day

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2019
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: June 8, 2017
• First Submitted That Met QC Criteria: June 12, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Actual): August 5, 2019
• Last Update Submitted That Met QC Criteria: August 1, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: U54 DA031659-06 Pilot; 1U54DA031659-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No