Trial · NCT04601207
A Study Investigating the Bioavailability of CBD and THC in an Emulsion Product in a Healthy Population
NCT04601207, Phase 1, Completed, New Age Ventures LLC
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study Investigating the Bioavailability of CBD and THC in an Emulsion Product in a Healthy Population. Trials, record NCT04601207. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04601207
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Investigating the Bioavailability of CBD and THC in an Emulsion Product in a Healthy Population
- NCT number
- NCT04601207
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 32 participants, actual
- Lead sponsor
- New Age Ventures LLC
- Conditions
- Healthy, Cannabis
- Interventions
- Cannabis Preparation, Cannabis Preparation
- First posted
- 2020-10-23
- Last updated
- 2021-03-03
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area under the curve (AUC0-48h) | 48 hours (Time points assessed for AUC0-48 h: pre-dose and post-dose at 10, 20, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 and 48 hours) | Area under the curve (AUC0-48h) for CBD, Δ9-THC, 11-OH-THC and 11-NOR-9-CARBOXY-Δ9-THC in plasma after the administration of the investigational product or active comparator product. |
| Primary | Maximum concentration (Cmax, 0-48h) | 48 hours (Time points assessed for AUC0-48 h: pre-dose and post-dose at 10, 20, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 and 48 hours) | Maximum concentration (Cmax, 0-48h) for CBD, Δ9-THC, 11-OH-THC and 11-NOR-9-CARBOXY-Δ9-THC in plasma after the administration of the investigational product or active comparator product. |
| Primary | Time to maximum concentration (Tmax) | 48 hours (Time points assessed for AUC0-48 h: pre-dose and post-dose at 10, 20, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 and 48 hours) | Time to maximum concentration (Tmax, 0-48h) for CBD, Δ9-THC, 11-OH-THC and 11-NOR-9-CARBOXY-Δ9-THC in plasma after the administration of the investigational product or active comparator product. |
| Secondary | Urine CBD concentration | 48 hours (Time points assessed are:0 (pre-dose), 0-4, 4-8, 8-12 hours, 12-24 hours and 24-48 hours post-dose) | CBD concentrations in urine after the acute administration of the investigational product and the active comparator product |
| Secondary | Urine Δ9-THC concentration | 48 hours (Time points assessed are:0 (pre-dose), 0-4, 4-8, 8-12 hours, 12-24 hours and 24-48 hours post-dose) | Δ9-THC concentrations in urine after the acute administration of the investigational product and the active comparator product |
| Secondary | Cognitive function | 48 hours | Assessment of cognitive functions by BrainCheck questionnaire for the investigational product and active comparator product. It involves tests of memory (immediate- and delayed-recall) and of cognitive processing and executive function (digit-symbol substitution, trail-making, Stroop Interference). Once a patient has completed the assessments, the BrainCheck platform immediately provides validated, norm-based scores to the investigators. These scores are adjusted for age, derived from a normative database ranging from ages 10 to 99. Raw scores for the different parameters are scaled and ranked in percentiles. Scores that fall within a range of one standard deviation above the mean (50th percentile) indicate "normal" cognitive function. So, overall scores above 50th percentile are graded normal cognitive function while those below 50th suggest cognitive impairment. |
| Secondary | Subjective evaluation of drug effects | 48 hours | This is done using the Drug-effect questionnaire (DEQ-5) which is a 5-question questionnaire evaluating the effects of the study product. The Five questions assess drug effects, perception and likability. The number and percentage of subjects per response will be presented for each time point according to treatment. Differences between groups will be assessed using a generalized linear mixed model assuming an ordinal response with treatment, time points and treatment by time points as fixed effects and subject as random effect.Outcomes will be summarized using descriptive statistics. |
| Other | Pre-emergent and post-emergent adverse events | 72 hours | The incidence of pre-emergent and post-emergent adverse events following a single dose of the investigational product and the comparator product. Adverse events are recorded in the study diary. |
| Other | Blood pressure | 48 hours post dose | The effect of a single dose of the investigational product and the comparator product on systolic and diastolic blood pressure |
| Other | Heart rate | 48 hours post dose | The effect of a single dose of the investigational product and the comparator product on heart rate |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes0
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35787693 | DERIVED |
Source PubMed
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT04601207
GET https://conductscience.org/api/trials/v1/NCT04601207/registered?page=2