Pharmacokinetics of THCCOOH and Its Acyl-glucuronide After Intravenous Administration of THCCOOH

A study on the fate and elimination of 11-Nor-Delta9-carboxy-9-tetrahydrocannabinol was up to now not conducted, except of one single experiment in which (lacking) psychopharmacological activity was tested after intravenous infusion of 20 mg in a human individual. In this study, however, the authors did not trace the above questions due to analytical and methodological deficits.

Aim of the study is to determine the pharmacokinetics of THCCOOH and THCCOOH-Glu after intravenous ad-ministration of 5 mg THCCOOH in healthy individuals

Completed

Looking for future studies?

Notify Me

Key information

Conditions

THCCOOH Cannabis Chemically-Induced Disorders Marijuana Abuse Mental Disorders Metabolism Pharmacokinetics Substance-Related Disorders

Age range

18 year–50 year

Sex eligibility

Male

Study type

Observational

Primary location

Clinical Research Center, Department of Internal Medicine VI

Heidelberg, 69120, Germany

About this study

To determine the pharmacokinetics of THCCOOH after intravenous administration of THCCOOH (5 mg) and its formed glucuronide in healthy individuals in order to improve the possibilities for the assessment of unfitness to drive. For these purposes the following criteria will be studied:

THCCOOH

Primary: Area under the plasma concentration time curve (AUCtotal) Maximal plasma concentrations (Cmax) Time of Cmax (tmax) Terminal elimination half-life (t1/2)
Secondary: Systemic and renal clearance (Cls, CLr) Volume of distribution of (Vc) Formed THCCOOH-glu
Primary: Area under the plasma concentration time curve (AUCtotal) Maximal plasma concentrations (Cmax) Time of Cmax (tmax) Terminal elimination half-life (t1/2)
Secondary: Systemic and renal clearance (Cls, CLr) Volume of distribution (Vc)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Good state of health (physically and mentally)

Exclusion criteria

Any regular drug treatment within the last two months
Any intake of a substance known to induce or inhibit drug metabolising enzymes or transport systems within a period of less than 10 times the respective elimination half-life
Any acute or chronic illness or clinically relevant findings in the pre-study examination
Allergies (except for mild forms of hay fever) or history of hypersensitivity reactions
Smoking (regular or irregular)
Excessive alcohol drinking (more than approximately 30 g alcohol per day)
Positive drug screening especially THC or known or admitted drug abuse

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

Pharmacokinetics of 11-Nor-9-carboxy-D9-tetrahydrocannabinol (THCCOOH) and Its Acyl-glucuronide (THCCOOH-GLu) After Intravenous Administration of THCCOOH in Healthy Human Subjects

Important dates

Study start: 2004
Study completion: 2005
First posted: Sep 15, 2005
Registry last updated: May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed