Cannabis Cigarettes Used for Doping: Delta-9-Tetrahydrocannabinol (THC) Urine Detection - Full Text View

Sponsor:	Federal Office of Sports, Switzerland
Information provided by:	Federal Office of Sports, Switzerland
ClinicalTrials.gov Identifier:	NCT00534716

Purpose

The purpose of this study on volunteers is whether THC and short-living metabolites are suited to detect recent Cannabis smoking within urine doping control.

Condition
Healthy

Study Type:	Observational
Study Design:	Prospective
Official Title:	Cannabis and Doping - Pharmacokinetics of Smoked Cannabis Under Controlled Clinical Conditions

Resource links provided by NLM:

MedlinePlus related topics: Urine and Urination

Drug Information available for: GW-1000 Tetrahydrocannabinol Cannabis

U.S. FDA Resources

Further study details as provided by Federal Office of Sports, Switzerland:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Plasma, urine

Enrollment:	12
Study Start Date:	September 2007
Study Completion Date:	May 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Detailed Description:

About half of all positive doping cases in Switzerland have been related to Cannabis consumption (mainly recreational smoking). So far, the target analyte in urine is 11-nor-9-carboxy-THC (THC-COOH), the main metabolite of delta-9-tetrahydrocannabinol (THC), which is excreted up to several days after single use. However, the wide detection window of THC-COOH does not allow a conclusion concerning the impact on the physical performance. Therefore, the evaluation of other target analytes with shorter elimination half-lives is needed and the aim (primary endpoints) of the present study. This pharmacokinetic, open, 1-session trial on 12 healthy, male, infrequently Cannabis smoking volunteers is focussed on the GC/MS profiling of THC and metabolites in urine and plasma after standardized smoking of a single 7% THC Cannabis cigarette of the Dutch Ministry of Health, Welfare & Sport, Office of Medicinal Cannabis. Pharmacodynamic measurements (secondary endpoints) include the side-effects monitoring by using Visual Analog Scales and checking vital functions.

Eligibility

Ages Eligible for Study:	20 Years to 30 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Healthy male subjects; light (max. 1/month), infrequent Cannabis smokers, medium (max. 15/month) tobacco smokers experienced in the inhalation technique; age 20-30 years; body weight 75+/-15 kg, normal medical history physical examination, passed laboratory tests (safety lab), normal lung functions (spirometry).

Criteria

Inclusion Criteria:

Healthy male subjects; light (max. 1/month), infrequent Cannabis smokers, medium (max. 15/month) tobacco smokers experienced in the inhalation technique; age 20-30 years; body weight 75+/-15 kg; evaluation based on normal medical history, physical examination, laboratory tests (safety lab), normal lung functions (spirometry).
Informed consent after information (written) by the study physician and principal investigator on nature, significance and scope of the trial.
Informed consent by the volunteer regarding transmitting trial-related data to the sponsor and to the competent control authorities.

Exclusion Criteria:

Hypersensitivity to cannabinoids. - Regular (more than once per month, weekly or daily) Cannabis use. - The use of alcohol, any medication or drugs, especially Cannabis, within the last 2 days prior to and during the 1-day session is not allowed. Cannabis use is also not allowed during the following 11 days of urine collection, i.e. up to the end of the study.
Positive Cannabis urine test before the session.
Driving any vehicle, and operating with machines during and within 48 h after the session.
Psychotic or vulnerable subjects.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534716

Locations

Switzerland
Clinical Investigation Unit (CIU), University Hospital ("Inselspital")
Bern, Switzerland, CH-3010

Sponsors and Collaborators

Federal Office of Sports, Switzerland

Investigators

Principal Investigator:

Rudolf Brenneisen, PhD, Prof

University of Bern, Dept. Clinical Research

More Information

No publications provided

Responsible Party:	Federal Office of Sports, Office for Doping Control ( Matthias Kamber, PhD )
Study ID Numbers:	KEK-33/07
Study First Received:	September 24, 2007
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00534716 History of Changes
Health Authority:	Switzerland: Swissmedic; Switzerland: Federal Office of Public Health

Keywords provided by Federal Office of Sports, Switzerland:

Cannabis
doping
THC

GC/MS
Pharmacokinetics
Volunteers

Additional relevant MeSH terms:

Tetrahydrocannabinol
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Hallucinogens
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010