Effects of E-cigarette Flavors on Youth TCORS 2.0

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Yale University

Status and phase

Completed
Phase 1

Conditions

Nicotine Use Disorder

Treatments

Drug: Nicotine
Drug: Flavoring Agents

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03634839
2U54DA036151-06 (U.S. NIH Grant/Contract)
2000023077-1

Details and patient eligibility

About

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.

Full 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. Forty youth (18-20 years of age) who have experience with e-cigarettes and will participate in 1 laboratory session. They will receive 1 nicotine concentrations (36mg/ml nicotine salt) during the session; during the session they will be exposed, in random order, to sweet (watermelon) and sweet-cooling (watermelon-menthol) flavors combined with the assigned session nicotine concentration.

Enrollment

40 patients

Sex

All

Ages

18 to 20 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Ages 18-20 years
  • Able to read and write
  • Used e-cigs at least 10 times in lifetime
  • Used e-cigs in past 30 days

Exclusion criteria

  • Current use of non-prescription substances besides nicotine, marijuana, alcohol
  • Any significant current medical or psychiatric condition
  • Known hypersensitivity to propylene glycol
  • Pregnant or lactating females
  • Uncontrolled asthma
  • Nut/e-liquid flavorant allergy
  • current marijuana (tetrahydrocannabinol) vaping + E-cigarette or vaping use Associated Lung Injury (EVALI) symptoms

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

40 participants in 2 patient groups

Sweet non-menthol, nicotine 36mg/ml
Experimental group
Description:
Sweet flavor non-menthol (Watermelon) with 36mg/ml Nicotine
Treatment:
Drug: Flavoring Agents
Drug: Nicotine
Sweet menthol, nicotine 36mg/ml
Experimental group
Description:
Sweet flavor with menthol (Watermelon-menthol) with 36mg/ml Nicotine
Treatment:
Drug: Flavoring Agents
Drug: Nicotine

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Wei Li; Danielle Davis, PhD

Data sourced from clinicaltrials.gov

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