Effects of Cannabis Administration Routes on Human Performance and Pharmacokinetics

Summary

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.

Conditions

• Cannabis Use

Interventions

DRUG

Placebo + Placebo

Participants will consume a brownie containing the equivalent of one placebo (0.001% THC) cigarette followed by smoking or inhaling (after vaporization) the equivalent of one placebo (0.001% THC) cigarette.

DRUG

Oral Cannabis + Placebo

Participants will consume a brownie containing the equivalent of one active (6.9% THC) cannabis cigarette followed by either smoking or inhaling (after vaporization) the equivalent of one placebo (0.001% THC) cigarette.

DRUG

Placebo + Inhaled Cannabis

Participants will consume a brownie containing the equivalent of one placebo (0.001% THC) cigarette

DRUG

Placebo + Smoked Cannabis

Participants will consume a brownie containing the equivalent of one placebo (0.001% THC) cigarette followed by smoking the equivalent of one active (6.9% THC) cigarette.

DRUG

6.9% cannabis oral

Participants will consume a brownie containing the equivalent of one active (6.91% THC) cannabis cigarette.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  lead NIH

Principal Investigators

• Marilyn Huestis, Ph.D. · National Institute on Drug Abuse (NIDA)

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-06-14

Primary Completion

2016-04-27

Completion

2016-04-27

Countries

• United States

Study Locations