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

This study has been completed.
Sponsor:
Information provided by:
Federal Office of Sports, Switzerland
ClinicalTrials.gov Identifier:
NCT00534716
First received: September 24, 2007
Last updated: May 6, 2008
Last verified: May 2008
  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: Time Perspective: Prospective
Official Title: Cannabis and Doping - Pharmacokinetics of Smoked Cannabis Under Controlled Clinical Conditions

Resource links provided by NLM:


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

Biospecimen Retention:   Samples Without DNA

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: Matthias Kamber, PhD, Federal Office of Sports, Office for Doping Control
ClinicalTrials.gov Identifier: NCT00534716     History of Changes
Other Study ID Numbers: KEK-33/07
Study First Received: September 24, 2007
Last Updated: May 6, 2008
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:
Marijuana Abuse
Substance-Related Disorders
Mental Disorders
Tetrahydrocannabinol
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014