Drug intoxication THC intoxication
Conditions
Interventions
All subjects of part A will receive 10.5 mg THC (10 tablets of 1.5 mg THC)
Subjects of part B will be administered a single dose of THC (between 10 and 40
mg) either as Namisol® or as dronabinol cap
Sponsors
Anebulo, pharmaceuticals, Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed consent prior to any study-mandated procedure 2. Healthy male or female subjects, 18 to 45 years of age, inclusive at screening. 3. Body mass index (BMI) between 18 and 30 kg/m2, inclusive at screening, and with a minimum weight of 50 kg. 4. All women of child bearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 90 days after their dose of study treatment. 5. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions. 6. Occasional cannabis users with a. Lifetime cannabis use on at least 10 occasions. b. In the past 6 months, the mean cannabis use should not exceed one occasion per week. c. Subjects should be able to refrain from using cannabinoids at least 3 weeks prior to dosing up to the end of the study. d. Urine drug screen must be negative prior to dosing.
Exclusion criteria
Exclusion criteria: 8. Participation in an investigational drug or device study (last dosing of previous study was within 90 days prior to first dosing of this study). 9. History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 21 units alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquillizers, or any other addictive agent other than recreative use of THC 10. Positive test for drugs of abuse (other than THC) at screening. 11. Positive test for drugs of abuse pre-dose. 17. If a woman; pregnant, or breast-feeding, or planning to become pregnant during the study. 19. Clinically significant suicidal ideation in the past 5 years as judged by the investigator or any life-time suicide attempts. 20. History of cannabis-induced psychosis, schizophrenia or other clinically relevant psychiatric disorders, as judged by the investigator. 21. History of a clinically significant mood disorder, including but not limited to major depressive disorder, as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Visual Analogue Scale (VAS) *Feeling High* according to modified Bowdle psychedelic scale (mm) • VAS *Alertness* according to Bond and Lader (mm) • Body sway: antero-posterior sway (mm); • Heart rate (bpm). | — |
Secondary
| Measure | Time frame |
|---|---|
| Parts A and B CNS-effects • VAS Bond and Lader: o mood (mm), o calmness (mm). • VAS Bowdle o Internal perception o External perception • State-Trait Anxiety Inventory (STAI) o State anxiety score • Saccadic eye movements: o saccadic reaction time (second), o saccadic peak velocity (degrees/second), and o saccadic inaccuracy (%); • Smooth pursuit eye movements: o percentage of time the eyes of the subjects are in smooth pursuit of the target (%); • Adaptive tracking: o average performance (%); • Pupillometry (mm) • N-Back o Average reaction time for zero, one and two-back (ms) o (nr correct - nr incorrect)/total for zero, one and two-back Starting with cohort 3 of Part B: • VAS *Any drug effect* (mm) • VAS *Good drug effect* (mm) • VAS *Bad drug effect* (mm) Parts A, B and C PK in plasma • AUCinf, AUClast, CL/F, Cmax, t1/2, tlag, tmax, Vz/F • Dose-normalized PK parameters: AUCinf, AUClast, Cmax PK in urine • Urine PK parameters: Aelast, Aelast%, CLR Safety • Treatment-emergent (serious) adverse events ((S)AEs) throughout the study at every study visit • Concomitant medication throughout the study at every study visit • Vital signs (Pulse Rate (bpm), Systolic blood pressure (mmHg), Diastolic blood pressure (mmHg), Respiratory Rate (pm), O2 Saturation (%)) as per assessment schedule • Clinical laboratory tests (Hematology, blood chemistry and urinalysis) as per assessment schedule • ECG parameters (Heart Rate (HR) (bpm), PR, QRS, QT, QTcB, QTcF) as per assessment schedule • VAS Nausea • Suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) • Depressive symptoms as assessed by Beck Depression Inventory-II • Dissociative symptoms as assessed by Clinician Administered Dissociative States Scale (CADSS) Part C: CNS effects: • VAS Bond and Lader: o mood (mm), o calmness (mm) • VAS Bowdle o Internal perception (mm) o External perception (mm) • State-Trait Anxiety Inventory • VAS Drug Effects o | — |
Countries
Netherlands
Outcome results
None listed