Trial document





This trial has been registered retrospectively.
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  DRKS00018836

Trial Description

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Title

Prospective, placebo-controlled, double-blind, randomized, cross-over study for the assessment of the blood concentration-response relationship of cannabidiol (CBD) and tetrahydrocannabinol (THC) after single and repetitive vapor inhalation of CBD-rich legal cannabis products and its potential implication on the driving ability

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Trial Acronym

CBDrive

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URL of the Trial

https://www.kofam.ch/de/studienportal/suche/59376/studie/46447

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Brief Summary in Lay Language

In Switzerland, CBD cannabis products can be purchased legally.
These contain high amounts of CBD but less than 1% THC, thus not leading to the well-known "high" after smoking illegal Cannabis.
However, driving ability after smoking CBD cannabis is only given in the following cases:
a) if THC concentrations do not exceed the legal limit of 1,5 microgram per litre blood as defined by the Federal Roads Office, and
b) if the product has no further impact on driving ability.
In individual cases it has been shown that the small amount of THC in CBD cannabis products can lead to excesses of the legal limit of 1,5 microgram per litre blood. So far, there have been no investigations on the impact CBD Cannabis products may have on driving ability. Hence, this study investigates these unresolved issues arising from a) and b).
Therefore, two separate study arms are conducted.
Study arm 1 investigates 40 healthy participants on three separate study visits. During each of the visits one of the following CBD cannabis products is consumed via vaporiser: 1) high CBD (~15%) and "high" legal THC (<1%) content; 2) high CBD (~15%) and "low" legal THC (0.2-0.3%) content; 3) low in CBD and THC Content (both < 0.3%). Study personnel and participant are blind to the product consumed during each visit. After consumption blood samples are collected regularly and urine samples at each time point of urination.
Blood and urine are analysed regarding their CBD, THC, and their metabolites content.
Further, neurocognitive tests for assessment of driving ability are conducted.
Study arm 2 investigates 20 healthy participants over a duration of 10 days. Participants are given a vaporiser and one of the two CBD-high cannabis products which they have to consume at home in the morning and in the evening. Every other day, participants have to come to the Institute where they consume the CBD cannabis under supervision. Before consumption urine and blood samples are collected. After consumption, another blood sample is collected.
On the last (10th) study day, participants are examined in the same way as participants of study arm 1. After consumption, blood samples are collected regularly and urine samples at each time point of urination.
Neurocognitive tests for assessment of driving ability are conducted

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Brief Summary in Scientific Language

In Switzerland cannabis products except hashish/cannabis resin which contain <1% tetrahydrocannabinol (THC) are not controlled by the narcotics legislation. Hence, so-called CBD-cannabis, which is high in cannabidiol (CBD) but contains <1% THC, can be legally sold as tobacco Substitute since it is not causing a "high" after consumption.

The driving ability after consumption CBD-cannabis is impaired, when
i) the Federal Roads Office (ASTRA)’s Limit of 1.5 μg/L THC is surpassed, and
ii) other effects of the product diminish the ability to drive.

However, neither i) nor ii) have been studied in enough detail to allow for science-based guidelines regarding the consumption of CBD-cannabis in conjunction with participation in road traffic.

This clinical trial investigates both i) and ii) after inhalative consumption of CBD-cannabis via vaporizers and thus provides an urgently needed scientific basis for future guidelines.

For this purpose, two study arms are conducted.

In study arm 1, 40 healthy participants consume three different CBD-Cannabis products on three different visits via a vaporiser. One product is a Placebo which contains ≤ 0.2% of CBD and THC. Two products contain high CBD (~15%). One contains "high" THC but still under the legal cut-off of 1%. The other product contains "low" THC (0.2-0.3%).
After consumption of the CBD-cannabis blood is regularly taken and urine is collected. These probes will be analysed for levels of THC, CBD, as well as their metabolites.
Additionally, several neurocognitive tests for assessing driving ability are conducted.

In study arm 2, 20 healthy participants consume one of the two CBD-cannabis products over the course of 10 days. Every other day, participants have to come in and consume under supervision. During this short visits, blood is taken before and after consumption. Urine is also collected. On day 10, participants are examined in the final visit and undergo the same procedure as described in study arm 1.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00018836
  •   2019/10/25
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  •   yes
  •   Approved
  •   2019-00639, Ethikkommission Nordwest- und Zentralschweiz
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Secondary IDs

  •   2019-00639 / SNCTP000003294  (Kofam/BASEC)
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Health Condition or Problem studied

  •   Healthy Participants
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Interventions/Observational Groups

  •   Single consumption:

    In study arm 1, healthy participants aged 18-65 years are administered (i.e. inhaled via a vaporizer) a study intervention (1) CBD >15%, THC 0.7-1%; 2) CBD >15%, THC ≤ 0.3%; 3) CBD and THC ≤ 0.2%). Before the intervention urine and blood samples are collected. Blood might be sent for analysis of polymorphisms of metabolizing enzymes such as cytochrome P450 family and UDP-glucuronosyltransferases (UGT) involved in xenobiotic transformation.
    A quick drug screening test is conducted in urine. In female participants of childbearing age a pregnancy test is administered as well. Furthermore, breath alcohol will be tested.

    After vaporization urine is collected at each time point of urination for up to 20 h post vaporization. Blood samples are collected prior to inhalation and after inhalation every 5 min during the first half hour, then every 10 min for up to one hour, and subsequently every 30 min for up to 5 h post vaporization.
    In 10 participants an additional blood sample will be collected at the returning of urine samples after a minimum of 20 h post vaporization.

    Questionnaires on the subjectively experienced effects of the administered interventions and general well-being are answered by the participant 20 min before and then immediately, 2.5 h and 5 h after vaporization.

    Paper/pencil tests are assessed between blood sampling within the first two hours after vaporization.
    Sixty minutes after vaporization participants undergo a driving test, followed by neurocognitive testing. Three hours after vaporization, driving and neurocognitive testing are repeated.

    Five hours after vaporization a final set of questionnaires is given to the participant.

    Upon the third completed visit, participants receive financial reimbursement.

  •   Frequent consumption:

    In study arm 2, healthy participants consume on 10 consecutive days one of the CBD-cannabis products via vaporiser in the morning and in the evening.
    Every other day participants have to come to the institute, where they consume the evening unit. Before and after consumption blood will be taken.
    All other Units are consumed at home.
    On the tenth and last day, participants undergo the same procedure for assessing driving ability as described in study arm 1 (single consumption). Subjective experience will be assessed in self-rating questionnaires.
    For the whole duration of study arm 2 urine is collected before CBD-cannabis consumption.

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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor, data analyst
  •   Placebo
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Blood and urine concentrations of CBD and THC after CBD-cannabis consumption.

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Secondary Outcome

Driving ability after CBD-cannabis consumption.

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Countries of Recruitment

  •   Switzerland
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2019/09/23
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

Age 18-65 years, driving license category B, sufficient knowledge of German language, experience
with nicotine and/or cannabis products.

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Exclusion Criteria

Psychiatric or physical disease (including addictive disorders), long-term medication, drug or alcohol abuse, insufficient knowledge of German language, no current driving license, pregnancy, breastfeeding or planned pregnancy in women, no experience with nicotine or cannabis products, limited availability, non-compliance regarding abstaining from alcohol, controlled substances, cannabis products (incl. CBD cannabis other than study intervention), non-compliance regarding abstaining from driving on study days.

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Addresses

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    • Institut für Rechtsmedizin der Universität Basel
    • Ms.  Prof. Dr. med. Dipl. phys.  Eva  Scheurer 
    • Pestalozzistrasse 22
    • 4056  Basel
    • Switzerland
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    • Institut für Rechtsmedizin der Universität Basel
    • Ms.  Dr. phil.  Laura  Egloff 
    • Pestalozzistrasse 22
    • 4056  Basel
    • Switzerland
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    • Institut für Rechtsmedizin der Universität Basel
    • Ms.  Dr. phil.  Laura  Egloff 
    • Pestalozzistrasse 22
    • 4056  Basel
    • Switzerland
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Sources of Monetary or Material Support

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    • Bundesamt für Gesundheit BAG
    • 3003  Bern
    • Switzerland
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.