PK/PD of Vaping THC-containing Liquids vs. Smoked Cannabis

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

About this trial

We will conduct a randomized, within-subjects clinical study to compare short-term pharmacokinetic (PK) and pharmacodynamic (PD) effects of Δ9-tetrahydrocannabinol (THC) vaping liquids vs. smoked cannabis containing 6 equivalent standard THC units (5 mg THC=1 Standard THC Unit (STU)) in healthy community members who are current users of both products. While smoking cannabis remains the most common mode of THC use among adults and youth, alternative modes of delivery, such as Electronic Vaping Products (EVPs), are becoming increasingly popular for the delivery of cannabinoids. Declining cannabis risk perceptions, increasing normalization of cannabis, greater legal access and availability to cannabis, ease of administration, and ability to conceal vaped THC use have likely contributed to increasing prevalence of use throughout the population across all age groups. Comparing vaping THC containing liquids with smoking cannabis can 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

Report concurrent use of commercial (medical or recreational) smoked cannabis and THC vaping cartridges for at least 3 months prior to enrollment

Report smoking cannabis and THC- vaping liquid use at the potency level of the study product at least weekly (4x/month)

Report of not currently trying to become pregnant (females). Women of childbearing potential must be willing to provide a urine sample and test negative prior to receiving any study-related products/procedures

Disqualifiers

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

Report 2 or more drinking occasions/week with 4 or more drinks/occasion

Report of daily nicotine use

Current or prior diagnosis of any psychotic disorders

Trial design

Treatments tested in this trial

  • Vape device
  • Joint
  • Marijuana via vape device
  • Marijuana via joint

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Roswell Park Cancer Institute

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator