Health TrialsbyHealthPanel

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

ConditionCannabis Dependence
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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood collection

  • Cannabis sativa Extract

    Drug

    Vape THC

  • Nicotine

    Drug

    Vape active nicotine

  • Placebo Administration

    Drug

    Vape placebo nicotine

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Arm A (placebo, THC, nicotine)Experimental treatment 5 interventions
Group B: Arm B (placebo, THC, nicotine)Experimental treatment 5 interventions
Group C: Arm C (placebo, THC, nicotine)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Maximum concentration of THC in plasma (Cmax)

Pharmacokinetics (PK) profiles of THC in plasma will be determined using a visual plot of plasma THC concentrations by time. Parameters will be derived using non-compartmental analysis in Phoenix WinNonlin and adjusted for baseline THC levels. Will be summarized by nicotine status using the appropriate descriptive statistics and graphical summaries.

Time frame
Up to 21 days
2

Area under the plasma concentration-time curve from 0-360 minutes (AUC0-360)

Blood samples will be collected for plasma levels of THC. Parameters will be derived using linear mixed models

Time frame
Up to 21 days
3

Time to maximum concentration of THC in plasma (Tmax)

Blood samples will be collected for plasma levels of THC. Parameters will be derived using linear mixed models.

Time frame
Up to 21 days

Secondary outcomes

1

Incidence of adverse events (AEs)

AEs will be summarized by nicotine condition and grade using frequencies and relative frequencies. Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting.

Time frame
Up to 30 days after completion of study intervention
2

Puffing behaviors

puff duration

Time frame
Up to 21 days
3

Puffing behaviors

puff number

Time frame
Up to 21 days
4

Short-term drug effects

The short-term drug effects (Drug Effects Questionnaire \[DEQ), The DEQ rates sixteen component items using a visual analog scale (0-100) to examine drug effects pre- and post-use

Time frame
Up to 21 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Roswell Park Cancer Institute

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: