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Trial record 3 of 19 for:    E-cigarettes youth

Effects of E-cigarette Flavors on Youth

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ClinicalTrials.gov Identifier: NCT03634839
Recruitment Status : Not yet recruiting
First Posted : August 17, 2018
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
This study is an examination of the influence of sweet and cooling flavors on the appeal and abuse potential of nicotine-containing e-cigarettes among susceptible youth.

Condition or disease Intervention/treatment Phase
Nicotine Use Disorder Drug: Flavor Drug: Nicotine Phase 1

Detailed Description:
Researchers will examine the influence of sweet and cooling flavors on the appeal and abuse potential of nicotine-containing e-cigarettes among susceptible youth. Participants will rate the flavor intensity, coolness, sweetness, and irritation experienced using validated rating scales. Sixty youth (16-20 years of age) who have experimented with e-cigarettes and are not regular users will participate in 3 laboratory sessions, separated by at least 24 hrs. They will be randomized to receive 1 of 3 nicotine concentrations (0, 3 or 12 mg/ml) during each of the three sessions; during each session they will be exposed, in random order, to sweet (strawberry, vanilla) and tobacco flavors, with and without menthol, combined with the assigned session nicotine concentration.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Official Title: Effects of E-cigarette Flavors on Youth
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Placebo Comparator: Nicotine 0 mg, Sweet non-menthol
Nicotine 0 mg combined with sweet non-menthol flavor
Drug: Flavor
Flavor of e-liquid - sweet or tobacco

Drug: Nicotine
Nicotine level (0, 3, or 12 mg)

Active Comparator: Nicotine 3 mg, Sweet non-menthol
Nicotine 3 mg combined with sweet non-menthol flavor
Drug: Flavor
Flavor of e-liquid - sweet or tobacco

Drug: Nicotine
Nicotine level (0, 3, or 12 mg)

Active Comparator: Nicotine 12 mg, Sweet non-menthol
Nicotine 12 mg combined with sweet non-menthol flavor
Drug: Flavor
Flavor of e-liquid - sweet or tobacco

Drug: Nicotine
Nicotine level (0, 3, or 12 mg)

Placebo Comparator: Nicotine 0 mg, Sweet menthol
Nicotine 0 mg combined with sweet menthol flavor
Drug: Flavor
Flavor of e-liquid - sweet or tobacco

Drug: Nicotine
Nicotine level (0, 3, or 12 mg)

Active Comparator: Nicotine 3 mg, Sweet menthol
Nicotine 3 mg combined with sweet menthol flavor
Drug: Flavor
Flavor of e-liquid - sweet or tobacco

Drug: Nicotine
Nicotine level (0, 3, or 12 mg)

Active Comparator: Nicotine 12 mg, Sweet menthol
Nicotine 12 mg combined with sweet menthol flavor
Drug: Flavor
Flavor of e-liquid - sweet or tobacco

Drug: Nicotine
Nicotine level (0, 3, or 12 mg)

Placebo Comparator: Nicotine 0 mg, Tobacco non-menthol
Nicotine 0 mg combined with tobacco non-menthol flavor
Drug: Flavor
Flavor of e-liquid - sweet or tobacco

Drug: Nicotine
Nicotine level (0, 3, or 12 mg)

Active Comparator: Nicotine 3 mg, Tobacco non-menthol
Nicotine 3 mg combined with tobacco non-menthol flavor
Drug: Flavor
Flavor of e-liquid - sweet or tobacco

Drug: Nicotine
Nicotine level (0, 3, or 12 mg)

Active Comparator: Nicotine 12 mg, Tobacco non-menthol
Nicotine 12 mg combined with tobacco non-menthol flavor
Drug: Flavor
Flavor of e-liquid - sweet or tobacco

Drug: Nicotine
Nicotine level (0, 3, or 12 mg)

Placebo Comparator: Nicotine 0 mg, Tobacco menthol
Nicotine 0 mg with tobacco menthol flavor
Drug: Flavor
Flavor of e-liquid - sweet or tobacco

Drug: Nicotine
Nicotine level (0, 3, or 12 mg)

Active Comparator: Nicotine 3 mg, Tobacco menthol
Nicotine 3 mg combined with tobacco menthol flavor
Drug: Flavor
Flavor of e-liquid - sweet or tobacco

Drug: Nicotine
Nicotine level (0, 3, or 12 mg)

Active Comparator: Nicotine 12 mg, Tobacco menthol
Nicotine 12 mg combined with tobacco menthol flavor
Drug: Flavor
Flavor of e-liquid - sweet or tobacco

Drug: Nicotine
Nicotine level (0, 3, or 12 mg)




Primary Outcome Measures :
  1. Change score in liking/wanting of e-cigarette [ Time Frame: Baseline (+10 minutes) to end of lab session (+40 minutes) ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 16-20 years
  • Able to read and write
  • Tried e-cigs at least once but no more than 10 times in lifetime
  • No past month 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03634839


Contacts
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Contact: Alissa Goldberg, LMSW 203-974-7809 alissa.goldberg@yale.edu
Contact: Asti Jackson, PhD 203-974-7598 asti.jackson@yale.edu

Locations
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United States, Connecticut
CMHC, Substance Abuse Center Not yet recruiting
New Haven, Connecticut, United States, 06519
Contact: Alissa Goldberg, LMSW    203-974-7809    alissa.goldberg@yale.edu   
Contact: Asti Jackson, PhD    203-974-7598    asti.jackson@yale.edu   
Principal Investigator: Suchitra Krishnan-Sarin, Ph.D.         
Sponsors and Collaborators
Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03634839     History of Changes
Other Study ID Numbers: 2000023077-1
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Menthol
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents