Trial · NCT03805750
Trial of Cannabis for Essential Tremor
NCT03805750, Phase 1, Phase 2, Completed, University of California, San Diego; results first posted 2022-10-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Cannabis for Essential Tremor. Trials, record NCT03805750. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03805750
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Cannabis for Essential Tremor
- NCT number
- NCT03805750
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- University of California, San Diego
- Conditions
- Essential Tremor
- Interventions
- CBD/THC, Placebo oral capsule
- First posted
- 2019-01-16
- Last updated
- 2022-10-13
- Results first posted
- 2022-10-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Digital Spirography | Day 22 (100 minutes post-dose) | The tremor mean amplitude calculated using computerized spirography to measure kinetic tremors. |
| Secondary | Change in Score on a Scale From Baseline of the Tremor Research Group Essential Tremor Rating Scale (TETRAS) | Baseline and Day 22 | The performance sub scale of the TETRAS will be used to measure tremor severity. The scale ranges from 0 to 60 points (0 being no tremor). |
| Secondary | Global Impression of Change | Day 22 | The Global impression of change will be calculated based on both physician and patient report. The scale ranges from a score of 1 (very much improved) to 7 (very much worse) with a score of 4 indicating 'no change'. |
| Secondary | Number of Participants Reporting Adverse Events Based on Common Terminology Criteria | Days 1, 3, 6, 22 | Side effects survey |
| Secondary | Number of Participants at Risk for Suicide Based on Columbia-Suicide Severity Rating Scale (C-SSRS) | Day 22 | This is a scale looking at risk assessment of suicidality. The presence of any positive responses will lead to further evaluation. |
| Secondary | Number of Participants With New Study-related Electrocardiogram (EKG) Abnormalities | Day 22 | Electrocardiographic changes from baseline measures will trigger further evaluation. EKG's will be rated as normal/abnormal relative to the baseline EKG reading, and abnormal findings will be rated as clinically significant/not clinically significant. |
| Secondary | Accelerometry-based Assessment of Tremor Severity | Baseline and Day 22 | The spectral power density measure of accelerometry data to measure will serve as a measure of tremor severity, comparing tremor amplitude from this digital biomarker at the time of the primary outcome to the same measure at baseline. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Digital Spirography | Day 22 (100 minutes post-dose) | millimeters of tremor amplitude | MEAN | |
| SECONDARY | Change in Score on a Scale From Baseline of the Tremor Research Group Essential Tremor Rating Scale (TETRAS) | Baseline and Day 22 | score on a scale | MEAN | |
| SECONDARY | Global Impression of Change | Day 22 | score on a scale | MEAN | |
| SECONDARY | Number of Participants Reporting Adverse Events Based on Common Terminology Criteria | Days 1, 3, 6, 22 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants at Risk for Suicide Based on Columbia-Suicide Severity Rating Scale (C-SSRS) | Day 22 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With New Study-related Electrocardiogram (EKG) Abnormalities | Day 22 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Accelerometry-based Assessment of Tremor Severity | Baseline and Day 22 | Participants in both treatment arms will undergone tremor measurement using accelerometry as a surrogate of tremor severity. | Proportion of baseline spectral power | MEAN |
Source ClinicalTrials.gov
Results by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Digital Spirography | CBD/THC | 1.04 | Standard Deviation 0.57 | millimeters of tremor amplitude | |
| Digital Spirography | Placebo | 1.00 | Standard Deviation 0.42 | millimeters of tremor amplitude | |
| Change in Score on a Scale From Baseline of the Tremor Research Group Essential Tremor Rating Scale (TETRAS) | CBD/THC | -8.07 | Standard Deviation 5.71 | score on a scale | |
| Change in Score on a Scale From Baseline of the Tremor Research Group Essential Tremor Rating Scale (TETRAS) | Placebo | -10.3 | Standard Deviation 3.9 | score on a scale | |
| Global Impression of Change | CBD/THC | Clinical Global Impression of Change | 3 | Full Range 3 to 4 | score on a scale |
| Global Impression of Change | Placebo | Clinical Global Impression of Change | 4 | Full Range 2 to 4 | score on a scale |
| Global Impression of Change | CBD/THC | Patient Global Impression of Change | 3 | Full Range 3 to 4 | score on a scale |
| Global Impression of Change | Placebo | Patient Global Impression of Change | 4 | Full Range 2.5 to 4 | score on a scale |
| Number of Participants Reporting Adverse Events Based on Common Terminology Criteria | CBD/THC | Ringing in ears | 7 | Participants | |
| Number of Participants Reporting Adverse Events Based on Common Terminology Criteria | Placebo | Ringing in ears | 6 | Participants |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention - 4 Weeks | STARTED | CBD/THC First Then Placebo | 3 | |
| First Intervention - 4 Weeks | STARTED | Placebo First Then CBD/THC | 4 | |
| First Intervention - 4 Weeks | COMPLETED | CBD/THC First Then Placebo | 3 | |
| First Intervention - 4 Weeks | COMPLETED | Placebo First Then CBD/THC | 4 | |
| First Intervention - 4 Weeks | NOT COMPLETED | CBD/THC First Then Placebo | 0 | |
| First Intervention - 4 Weeks | NOT COMPLETED | Placebo First Then CBD/THC | 0 | |
| Second Intervention - 4 Weeks | STARTED | CBD/THC First Then Placebo | 3 | |
| Second Intervention - 4 Weeks | STARTED | Placebo First Then CBD/THC | 4 | |
| Second Intervention - 4 Weeks | COMPLETED | CBD/THC First Then Placebo | 3 | |
| Second Intervention - 4 Weeks | COMPLETED | Placebo First Then CBD/THC | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ringing in ears | Ear and labyrinth disorders | CBD/THC | 7 | 7 | |
| other | Ringing in ears | Ear and labyrinth disorders | Placebo | 6 | 7 | |
| other | Numbness/tingling | Nervous system disorders | CBD/THC | 4 | 7 | |
| other | Numbness/tingling | Nervous system disorders | Placebo | 4 | 7 | |
| other | Dyspnea on exertion | Respiratory, thoracic and mediastinal disorders | CBD/THC | 4 | 7 | |
| other | Dyspnea on exertion | Respiratory, thoracic and mediastinal disorders | Placebo | 4 | 7 | |
| other | Watery eyes | Eye disorders | CBD/THC | 3 | 7 | |
| other | Watery eyes | Eye disorders | Placebo | 3 | 7 | |
| other | Runny nose | Respiratory, thoracic and mediastinal disorders | CBD/THC | 3 | 7 | |
| other | Runny nose | Respiratory, thoracic and mediastinal disorders | Placebo | 2 | 7 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CBD/THC | 0 | 7 |
| Total, all-cause mortality | Placebo | 0 | 7 |
| Total, other adverse events | CBD/THC | 7 | 7 |
| Total, other adverse events | Placebo | 6 | 7 |
| Total, serious adverse events | CBD/THC | 0 | 7 |
| Total, serious adverse events | Placebo | 0 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CBD/THC vs Placebo: Number of Participants With New Study-related Electrocardiogram (EKG) Abnormalities | Trial comparisons |
| CBD/THC vs Placebo: Number of Participants at Risk for Suicide Based on Columbia-Suicide Severity Rating Scale (C-SSRS) | Trial comparisons |
| CBD/THC vs Placebo: deaths from any cause | Trial comparisons |
| CBD/THC vs Placebo: serious adverse events | Trial comparisons |
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/NCT03805750
GET https://conductscience.org/api/trials/v1/NCT03805750/results?page=2