Trial · NCT07877987
The Impact of Dose on the Impairing, Intoxicating, and Abuse-Related Effects of Psilocybin
NCT07877987, Phase 1, Not yet recruiting, Johns Hopkins University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Impact of Dose on the Impairing, Intoxicating, and Abuse-Related Effects of Psilocybin. Trials, record NCT07877987. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07877987
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Impact of Dose on the Impairing, Intoxicating, and Abuse-Related Effects of Psilocybin
- NCT number
- NCT07877987
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 80 participants, estimated
- Lead sponsor
- Johns Hopkins University
- Conditions
- Psilocybin Intoxication
- Interventions
0mg Psilocybin Capsule + 0.00% BAC Alcoholic Drink, 1mg Psilocybin Capsule + 0.00% BAC Alcoholic Drink, 5mg Psilocybin Capsule + 0.00% BAC Alcoholic Drink, 15mg Psilocybin Capsule + 0.00% BAC Alcoholic Drink, 25mg Psilocybin Capsule + 0.00% BAC Alcoholic Drink, 0mg Psilocybin Capsule + 0.08% BAC Alcoholic Drink
- First posted
- 2026-10-16
- Last updated
- 2026-10-16
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Driving performance as assessed by standard deviation of lateral position (SDLP) | Baseline, 1, 3, 6, and 24 hours post-dosing | The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. SDLP (measured in cm) will be determined during each drive. This measure is a composite index of lateral control and incorporates lane weaving, swerving, and over-correcting. SDLP is the gold standard of quantifying the magnitude of driving impairment from drugs and alcohol and has excellent predictive validity to actual driving. Scores range from 0 to no upper limit. Higher scores represent higher magnitude of driving impairment. |
| Primary | Driving performance as assessed by global drive score during the simulated driving task | Baseline, 1, 3, 6, and 24 hours post-dosing | Driving impairment will be assessed using a composite driving score, with higher scores indicating greater impairment. The composite score is calculated by converting individual driving outcomes (see primary and secondary driving outcomes) into standardized z-scores and averaging these values to generate an overall composite score. Individual z-scores have a mean of 0 and a standard deviation (SD) of 1 in the reference sample used for standardization. The composite score has an expected mean of 0 in the reference sample, while its SD depends on the correlations among the individual driving outcomes and is not necessarily 1. |
| Primary | Total Clues and Cues exhibited during Standardized Field Sobriety Tests (SFSTs) | Baseline, 1, 3, 6, and 24 hours post-dosing. | Total Clues and Cues will be assessed across six field sobriety tests and summed into a single value. The maximum number of possible clues and cues is 29. Greater values indicate greater impairment of behavioral function during field sobriety tests. |
| Primary | Drug Effect Questionnaire (DEQ) - Feel Drug Effect | Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 24 hours post-dosing. | The DEQ will be used to obtain subjective ratings of "feel drug effects". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation. |
| Primary | Drug Effect Questionnaire (DEQ) - Drug Liking | Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 24 hours post-dosing. | The DEQ will be used to obtain subjective ratings of "drug liking". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation. |
| Primary | Drug Effect Questionnaire - Confidence to Drive | Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 24 hours post-dosing. | The DEQ will be used to obtain subjective ratings of "confidence to drive". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation. |
| Primary | Whole Psilocin Concentrations - THC Concentrations | Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 24 hours post-dosing. | Blood psilocin concentrations will be measured to assess changing in blood concentrations following drug administration. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DA066452 | The Impact of Dose on the Impairing, Intoxicating, and Abuse-Related Effects of Psilocybin | Zamarripa, Carlos Austin | JOHNS HOPKINS UNIVERSITY | NATIONAL INSTITUTE ON DRUG ABUSE | 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07877987
GET https://conductscience.org/api/trials/v1/NCT07877987/registered