Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age21+
SponsorRoswell Park Cancer Institute

About this trial

This clinical trial assesses differences in the delivery of THC to the bloodstream depending on whether nicotine vapes are used before or after THC. While there has been much recent publicity about vaping products and concern about their safety considering their increasing use for THC administration, the THC delivery profile associated with THC liquid vaping products in human subjects is currently unknown. Importantly, how the delivery to the bloodstream of THC vaping liquids compare to delivery from smoked cannabis, which is the most used method of cannabis delivery, will serve as an important benchmark for evaluating the delivery and effects of THC vaping products, and their relative safety.

Eligibility criteria

Qualifiers

Age ≥ 21 years of age; (self-reported on screening, verified at study visit).

Report use of commercial THC vaping cartridges for at least 3 months prior to enrollment; (self-reported).

Experience with THC potency at or above the study product AND experience with chasing THC with nicotine (at least monthly); (self-reported).

Report use of THC vaping liquids at least weekly (4x/month); (self-reported).

Disqualifiers

Detection level 4-5 (> 300 ng/mL) on urinary THCA rapid test (NarcoCheck® THC PreDosage Ref#: DOA-M03-9B) and a positive result on THC saliva test (NarcoCheck Ref#: NCE-S-THC-1).

Illegal or non-prescription drug use within the past 90 days. As detected by NarcoCheck® Évolutive® (detection in human urine of the 12 most currently abused drugs) at the first session and prior to receiving any study product. THC use detected by NarcoCheck® Évolutive® is permitted

Illegal or non-prescription drug use/alcohol substance use disorder (SUD) within the past year; (self-reported).

Report 2 or more drinking occasions/week with 4 or more drinks/occasion; (self-reported).

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Cannabis sativa Extract
  • Nicotine
  • Placebo Administration
  • Questionnaire Administration

Treatment groups

60 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Roswell Park Cancer Institute

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator