Alpha-pinene, THC
Conditions
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 6 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 6 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.
Interventions
DRUGPlacebo
Placebo vapor (distilled water)
DRUGTHC
Pure THC vapor
DRUGAlpha-Pinene
Pure alpha-pinene vapor
Sponsors
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
placebo controlled, double-blind
Intervention model description
All participants will complete all dose conditions (study arms) in a randomized order
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Peak Change From Baseline Drug Effect as Assessed by the Drug Effect Questionnaire (DEQ) | 0-6 hours, assessed at baseline, 0-hour, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, and 6 hours post dosing. | Mean Peak change from baseline rating (0-100) of Drug Effect on the DEQ, a visual analog scale (VAS) self-report questionnaire, with 0 being no effect and 100 being maximum effect. |
| Mean Peak Change From Baseline Psychomotor Performance as Assessed by the Digit Symbol Substitution Task (DSST) | 0-6 hours, assessed at baseline, 0-hour, and 0.5, 1, 1.5, 2, 3, 4, 5, and 6 hours post dosing. | 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). |
| Mean Peak Change From Baseline Working Memory Performance as Assessed by the Paced Auditory Serial Addition Task (PASAT) | 0-6 hours, assessed at baseline, 0-hour, and 0.5, 1, 1.5, 2, 3, 4, 5, and 6 hours post dosing. | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vaporized THC With and Without Pinene All study completers completed the following 6 conditions in a randomized order:
1. Placebo
2. High Pinene (15mg)
3. High THC (30mg)
4. High THC (30mg) and Low Pinene (0.5mg)
5. High THC (30mg) and Mid dose Pinene (5mg)
6. High THC (30mg and High Pinene (15mg) | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Vaporized THC With and Without Pinene |
|---|---|
| Age, Continuous | 30.57 years STANDARD_DEVIATION 8.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 19 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 22 | 0 / 20 | 0 / 21 | 0 / 20 | 0 / 21 |
| other Total, other adverse events | 0 / 20 | 0 / 22 | 8 / 20 | 0 / 21 | 1 / 20 | 4 / 21 |
| serious Total, serious adverse events | 0 / 20 | 0 / 22 | 0 / 20 | 0 / 21 | 0 / 20 | 0 / 21 |
Outcome results
Primary
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 on the DEQ, a visual analog scale (VAS) self-report questionnaire, with 0 being no effect and 100 being maximum effect.
Time frame: 0-6 hours, assessed at baseline, 0-hour, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, and 6 hours post dosing.
Population: Represents study completers
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Peak Change From Baseline Drug Effect as Assessed by the Drug Effect Questionnaire (DEQ) | -1.2 score on a scale | Standard Deviation 16.9 |
| Vaporized High Alpha-pinene | Mean Peak Change From Baseline Drug Effect as Assessed by the Drug Effect Questionnaire (DEQ) | 5.1 score on a scale | Standard Deviation 19.7 |
| Vaporized High THC Alone | Mean Peak Change From Baseline Drug Effect as Assessed by the Drug Effect Questionnaire (DEQ) | 67.2 score on a scale | Standard Deviation 27.4 |
| Vaporized High THC and Low Alpha-pinene | Mean Peak Change From Baseline Drug Effect as Assessed by the Drug Effect Questionnaire (DEQ) | 66.1 score on a scale | Standard Deviation 35.1 |
| Vaporized High THC and Mid-dose Alpha-pinene | Mean Peak Change From Baseline Drug Effect as Assessed by the Drug Effect Questionnaire (DEQ) | 61.5 score on a scale | Standard Deviation 37 |
| Vaporized High THC and High Alpha-pinene | Mean Peak Change From Baseline Drug Effect as Assessed by the Drug Effect Questionnaire (DEQ) | 62.9 score on a scale | Standard Deviation 38 |
Primary
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: 0-6 hours, assessed at baseline, 0-hour, and 0.5, 1, 1.5, 2, 3, 4, 5, and 6 hours post dosing.
Population: Represents study completers
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Peak Change From Baseline Psychomotor Performance as Assessed by the Digit Symbol Substitution Task (DSST) | 1.6 score on a scale | Standard Deviation 10.9 |
| Vaporized High Alpha-pinene | Mean Peak Change From Baseline Psychomotor Performance as Assessed by the Digit Symbol Substitution Task (DSST) | -4.2 score on a scale | Standard Deviation 10.4 |
| Vaporized High THC Alone | Mean Peak Change From Baseline Psychomotor Performance as Assessed by the Digit Symbol Substitution Task (DSST) | -12.6 score on a scale | Standard Deviation 16.9 |
| Vaporized High THC and Low Alpha-pinene | Mean Peak Change From Baseline Psychomotor Performance as Assessed by the Digit Symbol Substitution Task (DSST) | -11.2 score on a scale | Standard Deviation 13.2 |
| Vaporized High THC and Mid-dose Alpha-pinene | Mean Peak Change From Baseline Psychomotor Performance as Assessed by the Digit Symbol Substitution Task (DSST) | -8.2 score on a scale | Standard Deviation 11.9 |
| Vaporized High THC and High Alpha-pinene | Mean Peak Change From Baseline Psychomotor Performance as Assessed by the Digit Symbol Substitution Task (DSST) | -11.1 score on a scale | Standard Deviation 15.8 |
Primary
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: 0-6 hours, assessed at baseline, 0-hour, and 0.5, 1, 1.5, 2, 3, 4, 5, and 6 hours post dosing.
Population: Represents study completers
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Peak Change From Baseline Working Memory Performance as Assessed by the Paced Auditory Serial Addition Task (PASAT) | 1.8 score on a scale | Standard Deviation 10.3 |
| Vaporized High Alpha-pinene | Mean Peak Change From Baseline Working Memory Performance as Assessed by the Paced Auditory Serial Addition Task (PASAT) | 2.5 score on a scale | Standard Deviation 12.6 |
| Vaporized High THC Alone | Mean Peak Change From Baseline Working Memory Performance as Assessed by the Paced Auditory Serial Addition Task (PASAT) | -8.7 score on a scale | Standard Deviation 13.7 |
| Vaporized High THC and Low Alpha-pinene | Mean Peak Change From Baseline Working Memory Performance as Assessed by the Paced Auditory Serial Addition Task (PASAT) | -5.1 score on a scale | Standard Deviation 14.7 |
| Vaporized High THC and Mid-dose Alpha-pinene | Mean Peak Change From Baseline Working Memory Performance as Assessed by the Paced Auditory Serial Addition Task (PASAT) | -5.7 score on a scale | Standard Deviation 11.8 |
| Vaporized High THC and High Alpha-pinene | Mean Peak Change From Baseline Working Memory Performance as Assessed by the Paced Auditory Serial Addition Task (PASAT) | -7.5 score on a scale | Standard Deviation 12.9 |