Behavioral Pharmacology of THC and Alpha-pinene

Phase 1

Completed

Brief Summary: This study will evaluate the pharmacokinetics and pharmacodynamics of vaporized alpha-pinene and THC administered via inhalation.

Detailed Description: The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). Participants will complete 9 acute drug administration periods in which they will administer THC alone, pinene alone, THC and pinene together, or placebo. Subjective drug effects, cognitive performance, and vital signs will be assessed following drug administration. Each participant will receive all 9 dose conditions in a randomized order using a placebo controlled within-subject crossover design. The study will help the investigators understand the individual and interactive effects of THC and pinene, two common constituents found in cannabis.

Recruitment & Eligibility

Inclusion Criteria

Have provided written informed consent
Be between the ages of 18 and 55
Be in good general health based on a physical examination, medical history, vital signs, 12-lead ECG and screening urine and blood tests
Test negative for drugs of abuse other than cannabis, including breath alcohol at the screening visit and at clinic admission
Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission.
Have a body mass index (BMI) in the range of 18 to 36 kg/m2
Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg
Have no allergies to any of the ingredients used to prepare vapor (THC, pinene).
Demonstrate competency on cognitive performance measures at screening visit (e.g., PASAT score of 75/90).

Exclusion Criteria

Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine 3 month prior to the Screening Visit;
History of or current evidence of significant medical (e.g. seizure disorder) or psychiatric illness (e.g. psychosis) judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures.
Use of an over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
Use of a prescription medication (with the exception of birth control prescriptions) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
Use of dronabinol (Marinol®) within the past month.
Average use of cannabis more than 2 times per week in the prior 3 months.
History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
Abnormal EKG result that in the investigator's opinion is clinically significant.
Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.
Having previously sought medical attention to manage adverse effects following acute cannabis use.
Individuals with anemia or who have donated blood in the prior 30 days

Arm && Interventions

Group	Intervention	Description
Vaporized high THC alone	THC	25mg of vaporized pure THC
Vaporized high THC and high alpha-pinene	THC	5mg of vaporized alpha-pinene with 25mg vaporized THC
Vaporized high alpha-pinene	Alpha-Pinene	5mg of vaporized alpha-pinene
Vaporized high THC and high alpha-pinene	Alpha-Pinene	5mg of vaporized alpha-pinene with 25mg vaporized THC
Vaporized low THC alone	THC	10mg of vaporized pure THC
Placebo	Placebo	Placebo (5mL distilled water)
Vaporized high THC and low alpha-pinene	THC	0.5mg of vaporized alpha-pinene with 25mg vaporized THC
Vaporized low THC and low alpha-pinene	THC	0.5mg of vaporized alpha-pinene with 10mg vaporized THC
Vaporized low THC and high alpha-pinene	THC	5mg of vaporized alpha-pinene with 10mg vaporized THC
Vaporized low alpha-pinene	Alpha-Pinene	0.5mg of vaporized alpha-pinene
Vaporized high THC and low alpha-pinene	Alpha-Pinene	0.5mg of vaporized alpha-pinene with 25mg vaporized THC
Vaporized low THC and low alpha-pinene	Alpha-Pinene	0.5mg of vaporized alpha-pinene with 10mg vaporized THC
Vaporized low THC and high alpha-pinene	Alpha-Pinene	5mg of vaporized alpha-pinene with 10mg vaporized THC

Primary Outcome Measures

Name	Time	Method
Working memory performance as assessed by the Paced Auditory Serial Addition Task (PASAT)	6 hours	Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. Total correct trials out of 90 recorded is primary outcome (higher scores indicate better performance).
Self-reported Drug Effect as assessed by the Drug Effect Questionnaire (DEQ)	6 hours	Peak rating (0-100) of Drug Effect on the DEQ, with 0 being no effect and 100 being maximum effect.
Psychomotor performance as assessed by the Digit Symbol Substitution Task (DSST)	6 hours	Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Total correct trials in 90-seconds. Minimum score of 0 but no maximum score (higher scores indicate better performance).

Secondary Outcome Measures

Name	Time	Method

Locations (1): Johns Hopkins University
🇺🇸
Baltimore, Maryland, United States