Placebo
Placebo vapor (distilled water)
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This study will evaluate the pharmacokinetics and pharmacodynamics of vaporized alpha-pinene and THC administered via inhalation.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2025-05-22
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
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.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Placebo vapor (distilled water)
Pure THC vapor
Cannabis · Delta-9-THCPure alpha-pinene vapor
PineneSource-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
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.
Population: Represents study completers
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebo | 19 | -1.2 | 16.9 |
| Vaporized High Alpha-pinene | 19 | 5.1 | 19.7 |
| Vaporized High THC Alone | 19 | 67.2 | 27.4 |
| Vaporized High THC and Low Alpha-pinene | 19 | 66.1 | 35.1 |
| Vaporized High THC and Mid-dose Alpha-pinene | 19 | 61.5 | 37.0 |
| Vaporized High THC and High Alpha-pinene | 19 | 62.9 | 38.0 |
Eligibility
primary outcomes
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.
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 0.5, 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).
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.
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).
Publications
No exact PMID-linked public article is currently readable locally.
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).
Population: Represents study completers
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebo | 19 | 1.6 | 10.9 |
| Vaporized High Alpha-pinene | 19 | -4.2 | 10.4 |
| Vaporized High THC Alone | 19 | -12.6 | 16.9 |
| Vaporized High THC and Low Alpha-pinene | 19 | -11.2 | 13.2 |
| Vaporized High THC and Mid-dose Alpha-pinene | 19 | -8.2 | 11.9 |
| Vaporized High THC and High Alpha-pinene | 19 | -11.1 | 15.8 |
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).
Population: Represents study completers
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebo | 19 | 1.8 | 10.3 |
| Vaporized High Alpha-pinene | 19 | 2.5 | 12.6 |
| Vaporized High THC Alone | 19 | -8.7 | 13.7 |
| Vaporized High THC and Low Alpha-pinene | 19 | -5.1 | 14.7 |
| Vaporized High THC and Mid-dose Alpha-pinene | 19 | -5.7 | 11.8 |
| Vaporized High THC and High Alpha-pinene | 19 | -7.5 | 12.9 |
| Milestone | Vaporized Delta-9-tetrahydrocannabinol (THC) With and Without Alpha-Pinene |
|---|---|
| STARTED | 33 |
| Placebo | 20 |
| 15 mg Alpha-pinene | 22 |
| 30mg THC | 20 |
| 30mg THC / 0.5mg Pinene | 21 |
| 30mg THC / 5mg Pinene | 20 |
| 30mg THC / 15mg Pinene | 21 |
| COMPLETED | 19 |
| NOT COMPLETED | 14 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Dizziness | Nervous system disorders | Placebo: 0 / 20 · Vaporized High Alpha-pinene: 0 / 22 · Vaporized High THC Alone: 2 / 20 · Vaporized High THC and Low Alpha-pinene: 0 / 21 · Vaporized High THC and Mid-dose Alpha-pinene: 0 / 20 · Vaporized High THC and High Alpha-pinene: 2 / 21 |
| Anxiety | Social circumstances | Placebo: 0 / 20 · Vaporized High Alpha-pinene: 0 / 22 · Vaporized High THC Alone: 3 / 20 · Vaporized High THC and Low Alpha-pinene: 0 / 21 · Vaporized High THC and Mid-dose Alpha-pinene: 0 / 20 · Vaporized High THC and High Alpha-pinene: 0 / 21 |
| Nausea | Gastrointestinal disorders | Placebo: 0 / 20 · Vaporized High Alpha-pinene: 0 / 22 · Vaporized High THC Alone: 2 / 20 · Vaporized High THC and Low Alpha-pinene: 0 / 21 · Vaporized High THC and Mid-dose Alpha-pinene: 0 / 20 · Vaporized High THC and High Alpha-pinene: 0 / 21 |
| Tachycardia | Vascular disorders | Placebo: 0 / 20 · Vaporized High Alpha-pinene: 0 / 22 · Vaporized High THC Alone: 1 / 20 · Vaporized High THC and Low Alpha-pinene: 0 / 21 · Vaporized High THC and Mid-dose Alpha-pinene: 0 / 20 · Vaporized High THC and High Alpha-pinene: 0 / 21 |
| Lightheaded | Vascular disorders | Placebo: 0 / 20 · Vaporized High Alpha-pinene: 0 / 22 · Vaporized High THC Alone: 1 / 20 · Vaporized High THC and Low Alpha-pinene: 0 / 21 · Vaporized High THC and Mid-dose Alpha-pinene: 1 / 20 · Vaporized High THC and High Alpha-pinene: 0 / 21 |
| Fatigue | General disorders | Placebo: 0 / 20 · Vaporized High Alpha-pinene: 0 / 22 · Vaporized High THC Alone: 1 / 20 · Vaporized High THC and Low Alpha-pinene: 0 / 21 · Vaporized High THC and Mid-dose Alpha-pinene: 0 / 20 · Vaporized High THC and High Alpha-pinene: 2 / 21 |