Pregnenolone as a Treatment for Cannabis Intoxication
ConditionCannabis Intoxication
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJohns Hopkins University
About this trial
The present study will characterize the ability of pregnenolone to reverse the acute intoxication and associated symptoms of cannabis. Healthy adults with a history of cannabis use will be recruited to participate in a placebo-controlled, within-subject crossover study at Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). By clarifying the ability of pregnenolone to reverse cannabis intoxication symptoms, this study will pave the way for larger clinical studies that provide a foundation for the development of future CB1-receptor NAM medications that could be applied in emergency situations and potentially validate pregnenolone as a treatment for cannabis intoxication.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Ages 18-65
Good general health based on screening procedures (e.g. physical exam, blood testing, psychiatric evaluation)
Systolic blood pressure <140 mm Hg, diastolic blood pressure < 90 mm Hg, and heart rate <110 bpm at screening
Body mass index (BMI) in the range of 18 to 36 kg/m2
Disqualifiers
Use of psychoactive substances (aside from nicotine, caffeine, and alcohol) in the month prior to study initiation
Current use of over the counter (OTC) drugs, supplements/vitamins, or prescription medications that, in the opinion of the investigator or medical staff, will impact the participant's safety.
Current use of any prescription or non-prescription medications, including herbal medicines and supplements, that are known to interact with cannabis or pregnenolone
Self-report or ECG indicating clinically significant cardiovascular conditions, including coronary artery disease, stroke, angina, uncontrolled hypertension, arrhythmias (e.g. atrial fibrillation), heart valve placement, or TIA in the past year.
Trial design
Design model
Crossover
Treatments tested in this trial
Cannabis
DrugCannabis brownie, 25mg THC
Pregnenolone 250 mg
DrugPregnenolone, low dose, one 250mg pregnenolone capsule and one 0 mg pregnenolone capsule
Pregnenolone 500 mg
DrugPregnenolone, high dose, two 250 mg pregnenolone capsules
Placebo
DrugPlacebo capsule, 0mg
Placebo brownie
DrugPlacebo brownie, 0mg THC
Treatment groups
20 Participants
are divided into 4 treatment groupsGroup A: Placebo Brownie and CapsulesPlacebo comparator 2 interventions
Group B: Cannabis/THC brownie and Placebo CapsulesPlacebo comparator 2 interventions
Group C: Cannabis/THC Brownie and Pregnenolone, low doseExperimental treatment 2 interventions
Group D: Cannabis/THC Brownie and Pregnenolone, high doseExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Mean Peak Change From Baseline Drug Effect as Assessed by the Drug Effect Questionnaire (DEQ)
Mean Peak change from baseline rating (0-100) of Drug Effect items related to stimulation (e.g., alertness) and sedation (e.g., sleepy/tired) on the DEQ, a visual analog scale (VAS) self-report questionnaire, with 0 being no effect and 100 being maximum effect.
Time frame
baseline and 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dosing2
Mean peak change from baseline psychomotor performance as assessed by the Digit Symbol Substitution Task (DSST)
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Mean peak change from baseline total correct trials in 90-seconds. Minimum score of 0 but no maximum score (higher scores indicate better performance).
Time frame
baseline and 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dosing3
Mean peak change from baseline working memory performance as assessed by the Paced Auditory Serial Addition Task (PASAT)
Computerized version of Paced Auditory Serial Addition Task administered to assess working memory performance. Mean peak change from baseline total correct trials out of 90 recorded is primary outcome (higher scores indicate better performance).
Time frame
baseline and 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dosing4
Mean Peak Levels of Blood Pregnenolone, THC, and THC metabolites (11-OH-THC, and THCCOOH. )
Mean peak levels of pregnenolone, THC, and the THC metabolites 11-OH-THC, and THCCOOH in the blood of participants.
Time frame
baseline and 1.5, 2, 3, 4, and 6 hours post-dosingSecondary outcomes
1
Mean peak change from baseline psychomotor performance (attempted and percentage correct) as assessed by the Digit Symbol Substitution Task (DSST)
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Mean peak change from baseline total number attempted and percentage correct trials in 90-seconds. Minimum score of 0 but no maximum score (higher scores indicate better performance).
Time frame
baseline and 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dosing2
Mean peak change from baseline working memory performance (reaction time) as assessed by the Paced Auditory Serial Addition Task (PASAT)
Computerized version of Paced Auditory Serial Addition Task administered to assess working memory performance. Mean peak change from baseline reaction time on correct trials out of 90 recorded is secondary outcome (faster reaction times indicate better performance).
Time frame
baseline and 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dosing3
Mean Peak Change From Baseline Drug Effect (positive effect) as Assessed by the Drug Effect Questionnaire (DEQ)
Mean Peak change from baseline rating (0-100) of "positive" Drug Effect items (e.g., "like"; "want more) on the DEQ, a visual analog scale (VAS) self-report questionnaire, with 0 being no effect and 100 being maximum effect.
Time frame
baseline and 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dosing4
Mean Peak Change From Baseline Drug Effect (negative effect) as Assessed by the Drug Effect Questionnaire (DEQ)
Mean Peak change from baseline rating (0-100) of negative Drug Effect items (e.g., "dislike") on the DEQ, a visual analog scale (VAS) self-report questionnaire, with 0 being no effect and 100 being maximum effect.
Time frame
baseline and 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dosingSponsors and contacts
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Johns Hopkins University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov