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

Tobacco Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03186911
• Other study ID #: U54 DA031659-06 Pilot
• Secondary ID: 1U54DA031659-01
• Status: Withdrawn
• Phase: N/A
• Start date: July 2019
• Est. completion date: September 2019

Study information

• Verified date: October 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Institute on Drug Abuse (NIDA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Product Evaluation Questionnaire	Ratings of the two e-liquids on a self-report questionnaire	One Day
Secondary	Preference Assessment	Choices of each of the two e-liquids on a preference assessment	One Day
Secondary	Perceived Health Risk Questionnaire	Personal Health Risk Ratings about each of the two e-liquids	One Day
Secondary	Vaping Purchase Task	Hypothetical estimates of consumption of each of the e-liquids across a variety of prices	One Day