NCT02177513

Effects of Cannabis Administration Routes on Human Performance and Pharmacokinetics

Completed Phase 1 Last updated 16 December 2019

What this trial tests

Phase 1 trial testing Placebo + Placebo in Cannabis Use in 28 participants. Completed in 27 April 2016.

Timeline

14 June 2014

Primary endpoint
27 April 2016

27 April 2016

Quick facts

Lead sponsor	National Institute on Drug Abuse (NIDA)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	other
Enrollment	28
Start date	14 June 2014
Primary completion	27 April 2016
Estimated completion	27 April 2016
Sites	1 location across United States

Drugs / interventions tested

• Placebo + Placebo
• Oral Cannabis + Placebo — full drug profile →
• Placebo + Inhaled Cannabis — full drug profile →
• Placebo + Smoked Cannabis
• 6.9% cannabis oral — full drug profile →

Conditions studied

• Cannabis Use — all drugs for Cannabis Use →

Sponsor

National Institute on Drug Abuse (NIDA)

Who can join

Adults 18 to 50, any sex, with Cannabis Use. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

\- Marijuana (cannabis) is an illegal drug. Researchers want to study people s reactions, attention, and behavior after they take marijuana in different ways. They want to learn better ways to detect drugs in a person s body They also want to know how long marijuana can be found in blood, urine, saliva, and breath.

Objectives:

\- To learn how people respond to delta-9-tetrahydrocannabinol (THC, a marijuana component) and how their bodies handle it after it is given in different ways.

Eligibility:

\- Adults age 18 50 who use marijuana.

Design:

* Participants are screened under another NIDA protocol.
* This study involves up to 6 visits to NIDA.
* At the first visit, participants will practice the tasks and tests they will do at their dosing sessions. They will learn how to give breath and saliva samples.
* Dosing sessions 1 4 will last 3 5 days each. All participants will be admitted to a research clinic the night before these sessions. Some participants can stay at the clinic and some must go home between sessions.
* At each session, participants will eat a brownie with placebo or marijuana. Then they will smoke a placebo or marijuana cigarette. Some will inhale placebo or marijuana after it is vaporized.
* Throughout the sessions:
* Participants will give urine, saliva, and breath samples. Their blood will be taken with a tube in a vein and finger pricks. Their vital signs will be checked.
* Participants will answer questionnaires and take thinking tests. They will also take tests that assess eye movement, balance, and time estimation.
* Participants may have a 5th dosing session. They will eat a marijuana brownie and have the above tests and samples.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Free and Glucuronide Whole Blood Cannabinoids' Pharmacokinetics after Controlled Smoked, Vaporized, and Oral Cannabis Administration in Frequent and Occasional Cannabis Users: Identification of Recent Cannabis Intake.
   Newmeyer MN, Swortwood MJ, Barnes AJ, Abulseoud OA, et al · · 2016 · cited 125× · PMID 27899456 · DOI 10.1373/clinchem.2016.263475
2. Cannabinoid disposition in oral fluid after controlled smoked, vaporized, and oral cannabis administration.
   Swortwood MJ, Newmeyer MN, Andersson M, Abulseoud OA, et al · · 2017 · cited 68× · PMID 27647820 · DOI 10.1002/dta.2092
3. Effects of oral, smoked, and vaporized cannabis on endocrine pathways related to appetite and metabolism: a randomized, double-blind, placebo-controlled, human laboratory study.
   Farokhnia M, McDiarmid GR, Newmeyer MN, Munjal V, et al · · 2020 · cited 59× · PMID 32075958 · DOI 10.1038/s41398-020-0756-3
4. Cannabis Edibles: Blood and Oral Fluid Cannabinoid Pharmacokinetics and Evaluation of Oral Fluid Screening Devices for Predicting Δ⁹-Tetrahydrocannabinol in Blood and Oral Fluid following Cannabis Brownie Administration.
   Newmeyer MN, Swortwood MJ, Andersson M, Abulseoud OA, et al · · 2017 · cited 36× · PMID 28188235 · DOI 10.1373/clinchem.2016.265371
5. The acute effect of cannabis on plasma, liver and brain ammonia dynamics, a translational study.
   Abulseoud OA, Zuccoli ML, Zhang L, Barnes A, et al · · 2017 · cited 11× · PMID 28456476 · DOI 10.1016/j.euroneuro.2017.03.006