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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Chemically-Induced Disorders
Mental Disorders
Dronabinol
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
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 28, 2014