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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00534716
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : May 12, 2008
Information provided by:
Federal Office of Sports, Switzerland

Brief Summary:
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 or disease

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.

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Study Type : Observational
Actual Enrollment : 12 participants
Time Perspective: Prospective
Official Title: Cannabis and Doping - Pharmacokinetics of Smoked Cannabis Under Controlled Clinical Conditions
Study Start Date : September 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Biospecimen Retention:   Samples Without DNA
Plasma, urine

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes 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).

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00534716

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Clinical Investigation Unit (CIU), University Hospital ("Inselspital")
Bern, Switzerland, CH-3010
Sponsors and Collaborators
Federal Office of Sports, Switzerland
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Principal Investigator: Rudolf Brenneisen, PhD, Prof University of Bern, Dept. Clinical Research

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Responsible Party: Matthias Kamber, PhD, Federal Office of Sports, Office for Doping Control Identifier: NCT00534716     History of Changes
Other Study ID Numbers: KEK-33/07
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: May 12, 2008
Last Verified: May 2008

Keywords provided by Federal Office of Sports, Switzerland:

Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists