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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03635333
Other study ID # 2000023077-2
Secondary ID 2U54DA036151-06
Status Completed
Phase Phase 1
First received
Last updated
Start date March 15, 2019
Est. completion date July 12, 2023

Study information

Verified date February 2024
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers.


Description:

This study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers. Regular cigarette smokers who do not want to quit smoking will be asked to complete 3 lab sessions in which they will use an e-cigarette and complete questionnaires. This will be followed by a two-week period where participants are asked to stop using cigarettes and other tobacco products and to only use the e-cigarettes provided. Researchers will examine the influence of flavors (sweet, cool, tobacco) on reward (liking/wanting) from e-cigs containing one of two nicotine concentrations (6 mg/ml, 18 mg/ml) following acute tobacco abstinence.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date July 12, 2023
Est. primary completion date July 12, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Ages 18-24 years or 35 -50 years - Able to read and write - Smoking > 10 cigarettes or cigars/day - Willing to abstain from regular smoking for 2 weeks and use only e-cigarettes - Not seeking treatment to stop smoking - No regular use of e-cigarettes Exclusion Criteria: - Daily use of other drugs including prescribed psychoactive drugs - Any significant current medical or psychiatric condition - Known hypersensitivity to propylene glycol - Pregnant or lactating females

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nicotine
Nicotine level (6 or 18 mg)
Flavor
Flavor of e-juice (tobacco, menthol, strawberry)

Locations

Country Name City State
United States CMHC, Substance Abuse Center New Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Yale University National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change score in liking/wanting of e-cigarette The Labeled Hedonic Scale (LHS; Lim et al., 2009) will be used to ask about liking and wanting of the e-cigarette (one item VAS scale with ratings from most disliked sensation imaginable to most liked sensation imaginable with higher values indicating greater liking) Baseline (+10 minutes) to end of lab session (+40 minutes)
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