Status:
TERMINATED
Cannabis Effects on Electroencephalography
Lead Sponsor:
Parc de Salut Mar
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Background: Tetrahydrocannabinol (THC) is a partial CB1/CB2 agonist and causes its pharmacological effects by binding to cannabinoid receptors. CB1 receptors are predominantly located in the brain (h...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2020
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04316598
Start Date
March 3 2020
End Date
July 9 2020
Last Update
July 31 2020
Active Locations (1)
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1
IMIM (Hospital del Mar Medical Research Institute)
Barcelona, Spain, 08003