Trial of Cannabis for Essential Tremor
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| ClinicalTrials.gov Identifier: NCT03805750 |
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Recruitment Status :
Completed
First Posted : January 16, 2019
Results First Posted : October 13, 2022
Last Update Posted : October 13, 2022
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Sponsor:
University of California, San Diego
Collaborators:
International Essential Tremor Foundation
Tilray
Center for Medicinal Cannabis Research
Information provided by (Responsible Party):
Fatta B Nahab, University of California, San Diego
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Essential Tremor |
| Interventions |
Drug: CBD/THC Drug: Placebo oral capsule |
| Enrollment | 7 |
Participant Flow
| Recruitment Details | This is a cross-over design where each subject receives both a placebo and treatment arm in blinded random order. |
| Pre-assignment Details |
| Arm/Group Title | CBD/THC First Then Placebo | Placebo First Then CBD/THC |
|---|---|---|
 Arm/Group Description |
After randomization, each patient will receive study medication in two study periods. Each study period includes 1-week titration, 2-week treatment, and 1-week tapering. There is a 3-week washout period between the two study periods. During the titration period, patients will have a starting dose of 1 capsule (placebo or 5mg THC/100mg CBD) per day; 2 capsules per day on day 3; 3 capsules per day on day 6. If the patient or investigator feel that the higher study drug dose of 3 caps per day is causing troublesome side effects, the dosage may be lowered to 2 caps per day. Patients will continue on this target dose during the 2-week treatment and then gradually taper from medication over one week. Patients will crossover to the alternate treatment after a 3-week washout period. | After randomization, each patient will receive study medication in two study periods. Each study period includes 1-week titration, 2-week treatment, and 1-week tapering. There is a 3-week washout period between the two study periods. During the titration period, patients will have a starting dose of 1 capsule (placebo or 5mg THC/100mg CBD) per day; 2 capsules per day on day 3; 3 capsules per day on day 6. If the patient or investigator feel that the higher study drug dose of 3 caps per day is causing troublesome side effects, the dosage may be lowered to 2 caps per day. Patients will continue on this target dose during the 2-week treatment and then gradually taper from medication over one week. Patients will crossover to the alternate treatment after a 3-week washout period. |
| Period Title: First Intervention - 4 Weeks | ||
| Started | 3 | 4 |
| Completed | 3 | 4 |
| Not Completed | 0 | 0 |
| Period Title: Second Intervention - 4 Weeks | ||
| Started | 3 | 4 |
| Completed | 3 | 2 |
| Not Completed | 0 | 2 |
| Reason Not Completed | ||
| Adverse Event | 0 | 2 |
Baseline Characteristics
| Arm/Group Title | All Participants | |
|---|---|---|
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Arm/Group Description |
After randomization, each patient will receive study medication in two study periods. Each study period includes 1-week titration, 2-week treatment, and 1-week tapering. There is a 3-week washout period between the two study periods. During the titration period, patients will have a starting dose of 1 capsule (placebo or 5mg THC/100mg CBD) per day; 2 capsules per day on day 3; 3 capsules per day on day 6. If the patient or investigator feel that the higher study drug dose of 3 caps per day is causing troublesome side effects, the dosage may be lowered to 2 caps per day. Patients will continue on this target dose during the 2-week treatment and then gradually taper from medication over one week. Patients will crossover to the alternate treatment after a 3-week washout period. | |
| Overall Number of Baseline Participants | 7 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 7 participants | |
| <=18 years |
0 0.0%
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| Between 18 and 65 years |
4 57.1%
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| >=65 years |
3 42.9%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 7 participants | |
| 67.0 (11.3) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 7 participants | |
| Female |
0 0.0%
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| Male |
7 100.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 7 participants | |
| Hispanic or Latino |
0 0.0%
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| Not Hispanic or Latino |
7 100.0%
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| Unknown or Not Reported |
0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 7 participants | |
| American Indian or Alaska Native |
0 0.0%
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| Asian |
0 0.0%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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| Black or African American |
0 0.0%
|
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| White |
7 100.0%
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| More than one race |
0 0.0%
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| Unknown or Not Reported |
0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 7 participants |
| 7 | ||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | F.B. Nahab MD |
| Organization: | University of California San Diego |
| Phone: | 858-822-6683 |
| EMail: | fnahab@health.ucsd.edu |
| Responsible Party: | Fatta B Nahab, University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT03805750 |
| Other Study ID Numbers: |
180414 |
| First Submitted: | January 9, 2019 |
| First Posted: | January 16, 2019 |
| Results First Submitted: | February 15, 2022 |
| Results First Posted: | October 13, 2022 |
| Last Update Posted: | October 13, 2022 |