Cannabis Effects on Electroencephalography
Maneno muhimu
Kikemikali
Maelezo
Subjects will be randomly assigned in a 2:1 ratio to either Arm A (Cannabis) or Arm B (Cannabis placebo). The subjects, Investigators and designees involved in the conduct of the study will be blinded to the identity of the treatment administered during the study.
In the active group (Arm A) subjects will be administered four single doses of 20 mg THC over 3 days, equivalent to 285.7 μg/kg. This dose is considered to be sufficient for eliciting the psychoactive effects of THC (> 5 ng/mL in plasma) and modify EEG, avoiding subjects to be too much behaviorally impaired.
THC will be administered in the form of medical cannabis (Bedrocan®) inhaled by intrapulmonary route. It is featured in flos form (Cannabis sativa dried female flower) containing THC 22% and cannabidiol (CBD) <1%. A vaporization system (Mighty® Medic device) will be used for cannabis administration. Through this system, the final inhalation of THC is comparable to that of smoking cannabis while reducing the inhalation of toxic and irritating substances generated in the combustion of herbs.
Tarehe
| Imethibitishwa Mwisho: | 04/30/2020 |
| Iliyowasilishwa Kwanza: | 03/17/2020 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 03/18/2020 |
| Iliyotumwa Kwanza: | 03/19/2020 |
| Sasisho la Mwisho Liliwasilishwa: | 05/20/2020 |
| Sasisho la Mwisho Lilichapishwa: | 05/21/2020 |
| Tarehe halisi ya kuanza kwa masomo: | 03/02/2020 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 07/31/2020 |
| Tarehe ya Kukamilisha Utafiti: | 07/31/2020 |
Hali au ugonjwa
Uingiliaji / matibabu
Drug: Cannabis (B)
Drug: Cannabis placebo (B)
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Experimental: Cannabis (B) Subjects will be admitted in the center to receive 4 doses of inhaled cannabis in 3 days.
Vital signs, blood test and electroencephalogram (Starlab® helmet) will be performed before and after every cannabis administration. Cannabis subjective effects will be assessed and a psychiatric research interview will also be performed at different times after administration. | Drug: Cannabis (B) Subjects will receive a total of 4 inhaled doses of 20 mg of tetrahydrocannabinol (THC) in 3 days.
Cannabis is provided as a medical grade cannabis flos (Cannabis sativa dried female flower) containing THC 22% and cannabidiol <1%, supplied by Bedrocan®.
To avoid the respiratory disadvantages of smoking, a vaporization device (Mighty® Medic) will be used to inhale the drug. The prepared capsules will contain 90 mg of Cannabis flos, equivalent to 20 mg of THC. |
| Placebo Comparator: Cannabis placebo (B) Subjects will be admitted in the center to receive 4 doses of an inhaled treatment based on placebo-THC in 3 days.
Vital signs, blood test and electroencephalogram (Starlab® helmet) will be performed before and after every administration. Cannabis subjective effects will be assessed and a psychiatric research interview will also be performed at different times after administration. | Drug: Cannabis placebo (B) Subjects will receive a total of 4 inhaled doses of cannabis placebo (THC <0,2%) in 3 days.
Placebo cannabis is provided as a medical grade cannabis flos (Cannabis sativa dried female flower) containing cannabinoids <0.2%. To avoid the respiratory disadvantages of smoking, a vaporization device (Mighty® Medic) will be used to inhale the drug. The prepared capsules will contain 90 mg of cannabis placebo. |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
| Jinsia Inastahiki Kujifunza | All |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | Inclusion Criteria: - Healthy male or female subjects. - Negative urine pregnancy test and effective contraception method for female of child-bearing potential (see footnote at the end of subheading 5). - Age ≥ 18 and ≤ 55 years. - Weight ≥ 50 kg and ≤ 100 kg. - Body mass index (BMI) ≥ 18 and ≤ 30. - Recreational cannabis use with a cannabis use history ≥ 6 months and a cannabis consumption in the last month ≥ 1 day/month and ≤ 2 days/week. - Last cannabis consumption ≥ 1 week before Day 1. - Negative urine drug test but for cannabis. - Consistent drug hair test (performed during screening) with drug use medical history. - Able to read Spanish and adhere to study requirements. - Not under any administrative or legal supervision. - Signed informed consent prior to any study-mandated procedure. Exclusion Criteria: - Pregnant or nursing female. - Cannabis-naive subjects. - Life-time cannabis use disorder (CUD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria using the Psychiatric Research Interview for Substance and Mental Disorders (PRISM). - Recreational use of opioids, cocaine, psychostimulants within the last month. - Life-time other substance use disorders (SUD) according to the DSM-5 criteria using PRISM, except for mild alcohol use disorder and/or mild or moderate nicotine use disorder. - Life-time history of bipolar disorders, psychosis or suicidal attempts assessed by the Dual Diagnosis Screening Instrument (DDSI). - Past-12 months history of anxiety or depression assessed by the DDSI. - Life-time clinically significant cardiovascular, renal, pulmonary, hepatic, onco-hematological, endocrine, gastrointestinal or neurological disease. - Any other diseases or conditions that in the judgment of the investigator would interfere with the subject's ability to comply with study procedures or requirements and/or study results interpretation. - Any clinically significant findings in physical examination including vital signs, EEG and safety laboratory parameters. - Any prescription or over the counter drug (except occasional use of paracetamol) in the last 2 weeks before Day 1 of each period. - Patient included in a clinical study in the last three months. |
Matokeo
Hatua za Matokeo ya Msingi
1. Number of Participants with EEG alterations [45 minutes pre-administration to 45 minutes post-administration]
Hatua za Matokeo ya Sekondari
1. Number of Participants with subjective effects [Before administration, at 15, 50, 75 and 105 minutes post-administration]
2. Number of Participants with alterations in cardiovascular function [Before administration to 60 minutes post-administration]
3. Number of Participants with neuroendocrine alterations [Before administration, at 10 and 60 minutes post-administration]
4. Time-profile of THC [Before administration, at 10 and 60 minutes post-administration]
5. Time-profile of OH-THC [Before administration, at 10 and 60 minutes post-administration]
6. Time-profile of THC-COOH [Before administration, at 10 and 60 minutes post-administration]
