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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA043475 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study will evaluate the pharmacokinetics and pharmacodynamics of vaporized alpha-pinene and THC administered via inhalation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo (5mL distilled water) |
|
| Vaporized Pinene | Experimental | 15mg vaporized alpha-pinene |
|
| Vaporized THC | Experimental | 30mg vaporized delta-9-THC |
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| Vaporized THC and low alpha-pinene | Experimental | 30mg vaporized delta-9-THC and 0.5mg of vaporized alpha-pinene |
|
| Vaporized THC and alpha-pinene | Experimental | 30mg vaporized delta-9-THC and 5mg of vaporized alpha-pinene |
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| Vaporized THC and high alpha-pinene | Experimental | 30mg vaporized delta-9-THC and 15mg of vaporized alpha-pinene |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo vapor (distilled water) |
| |
| THC |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 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). | 0-6 hours, assessed at baseline, 0-hour, and 0.5, 1, 1.5, 2, 3, 4, 5, and 6 hours post dosing. |
| 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). | 0-6 hours, assessed at baseline, 0-hour, and 0.5, 1, 1.5, 2, 3, 4, 5, and 6 hours post dosing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Vandrey, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21224 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vaporized Delta-9-tetrahydrocannabinol (THC) With and Without Alpha-Pinene | Participants vaporized THC and pinene in a within-subject crossover design:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Study completers are reported. 19 participants completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vaporized THC With and Without Pinene | All study completers completed the following 6 conditions in a randomized order:
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| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Represents study completers | Posted | Mean | Standard Deviation | score on a scale | 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. |
|
Up to 6 hours post dose
International Council for Harmonisation (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo (5mL distilled water) Placebo: Placebo vapor (distilled water) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| C. Austin Zamarripa, PhD | Johns Hopkins University School of Medicine | 410-550-6969 | czamarr2@jh.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 18, 2024 | Apr 8, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| C587251 | nabiximols |
| C005451 | alpha-pinene |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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All participants will complete all dose conditions (study arms) in a randomized order
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placebo controlled, double-blind
|
| Drug |
Pure THC vapor |
|
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| Alpha-Pinene | Drug | Pure alpha-pinene vapor |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG002 | Vaporized High THC Alone | 30mg of vaporized pure THC THC: Pure THC vapor |
| OG003 | Vaporized High THC and Low Alpha-pinene | 30mg vaporized THC with 0.5mg of vaporized alpha-pinene THC: Pure THC vapor Alpha-Pinene: Pure alpha-pinene vapor |
| OG004 | Vaporized High THC and Mid-dose Alpha-pinene | 30mg vaporized THC with 5.0mg of vaporized alpha-pinene with THC: Pure THC vapor Alpha-Pinene: Pure alpha-pinene vapor |
| OG005 | Vaporized High THC and High Alpha-pinene | 30mg of vaporized pure THC and 15mg alpha- pinene THC: Pure THC vapor Alpha-Pinene: Pure alpha-pinene vapor |
|
|
| 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). | Represents study completers | Posted | Mean | Standard Deviation | score on a scale | 0-6 hours, assessed at baseline, 0-hour, and 0.5, 1, 1.5, 2, 3, 4, 5, and 6 hours post dosing. |
|
|
|
| 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). | Represents study completers | Posted | Mean | Standard Deviation | score on a scale | 0-6 hours, assessed at baseline, 0-hour, and 0.5, 1, 1.5, 2, 3, 4, 5, and 6 hours post dosing. |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Vaporized High Alpha-pinene | 15mg of vaporized alpha-pinene Alpha-Pinene: Pure alpha-pinene vapor | 0 | 22 | 0 | 22 | 0 | 22 |
| EG002 | Vaporized High THC Alone | 30mg of vaporized pure THC THC: Pure THC vapor | 0 | 20 | 0 | 20 | 8 | 20 |
| EG003 | Vaporized High THC and Low Alpha-pinene | 30mg vaporized THC with 0.5mg of vaporized alpha-pinene THC: Pure THC vapor Alpha-Pinene: Pure alpha-pinene vapor | 0 | 21 | 0 | 21 | 0 | 21 |
| EG004 | Vaporized High THC and Mid-dose Alpha-pinene | 30mg vaporized THC with 5.0mg of vaporized alpha-pinene with THC: Pure THC vapor Alpha-Pinene: Pure alpha-pinene vapor | 0 | 20 | 0 | 20 | 1 | 20 |
| EG005 | Vaporized High THC and High Alpha-pinene | 30mg of vaporized pure THC and 15mg alpha- pinene THC: Pure THC vapor Alpha-Pinene: Pure alpha-pinene vapor | 0 | 21 | 0 | 21 | 4 | 21 |
| Anxiety | Social circumstances | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Tachycardia | Vascular disorders | Non-systematic Assessment |
|
| Lightheaded | Vascular disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
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