The primary objective is to evaluate the inhalation process and the overall satisfaction with the use of the Investigational Medicinal Products (IMPs). The secondary objectives are to determine the subjective effects after pulmonary administration…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
no health condition is addressed in the research, and healthy volunteers who are occasional cannabis users will be recruited
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The inhalation process and the overall satisfaction with the use of the IMPs
will be assessed by the means of Likert scales.
Secondary outcome
Subjective drug effects will be measured by a series of VAS/Bowdle
questionnaire/CADDS. The assessment of the quality of the IMPs by participants
will be measured by a series of Likert scales. Cognition will be assessed by a
computerized test battery. Memory, i.e. sensitivity to go along with suggested
self-incriminating statements will be assessed using an adjusted false
confession paradigm.
Background summary
In line with the current legal regulations, a medicinal cannabis product is
considered standardized as long as the actual values of the active ingredients
are within ±20% deviation from the declared values. These regulations are
expected to change in the near future, by changing the limit to ±10% deviation.
In order to comply with these stricter criteria, Bedrocan, the producer of
medicinal cannabis in the Netherlands, needs to develop new forms of its
cannabis products. There is a need to investigate which form of cannabis will
result in an optimal experience for users (primary goal). Moreover, the study
will also inquire the impact of these cannabis forms on cognitive and memory
functions during intoxication with Δ9-tetrahydrocannabinol (THC; secondary
goal).
Study objective
The primary objective is to evaluate the inhalation process and the overall
satisfaction with the use of the Investigational Medicinal Products (IMPs). The
secondary objectives are to determine the subjective effects after pulmonary
administration of the IMPs, to record the emergence of any potential adverse
events, and the assessment of the quality of the IMPs by participants. In
addition, we will assess how cannabis intoxication affects cognitive and memory
function.
Study design
The study will employ a double-blind, randomized, placebo-controlled, crossover
design. Occasional (N=25 incl. dropout) cannabis users will receive a single
dose of vaporized cannabis (Bedrocan) containing 15 mg of THC, or placebo.
There will be 4 separate sessions (with each session separated by a minimum of
7 days) in a randomised and counter-balanced order. During each of the 3
Bedrocan sessions, cannabis will be administered in a different form
(granulate, powder, yellowcake).
Intervention
Participants will undergo 4 experimental conditions, in which they receive a
fixed dose of Bedrocan cannabis in different forms (granulate, powder and
yellowcake) or placebo. In each condition, the dose will contain 15 mg THC and
<1.0% mg CBD.
Study burden and risks
The effects of THC occur very rapidly after inhalation and disappear within 2
to 3 hours. The given dose has been given to participants in previous studies
with minor adverse events and is well tolerated in recreational cannabis users.
Expected effects include mild relaxation, alteration of visual, auditory, and
olfactory senses, fatigue, and appetite stimulation. Serious acute adverse
effects of cannabis may include anxiety and panic attacks, vomiting,
tachycardia and an increase in blood pressure; however, these are typically
induced at much higher doses than what will be administered in this study.
Placebo cannabis is not expected to cause any side effects, given that the
concentrations of active cannabinoids are at negligible levels.
Universiteitssingel 40
Maastricht 6229ER
NL
Universiteitssingel 40
Maastricht 6229ER
NL
Listed location countries
Age
Inclusion criteria
• Occasional cannabis users (>10 lifetime exposures and <= 2 times/week in the
previous 3 months)
• Age between 18-50
• Good physical health as determined by medical examination and laboratory
analysis
• Absence of any major medical, endocrine and neurological condition
• Normal weight, body mass index (weight/height2) between 18 and 30 kg/m2
• Written Informed Consent
Exclusion criteria
• History of drug abuse (other than the use of cannabis) or addiction
(determined by the medical questionnaire, drug questionnaire and medical
examination)
• Pregnancy or lactation (pregnancy test, if needed)
• Hypertension (diastolic > 90; systolic > 140)
• Current or history of psychiatric disorder (determined by the medical
questionnaire and medical examination)
• Liver dysfunction
• Any serious prior adverse response to cannabis
• History of cardiac dysfunctions (e.g. arrhythmia, ischemic heart disease)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-002387-30-NL |
| CCMO | NL74382.068.20 |