Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248378
Status:
COMPLETED
Last Update Posted:
2006-06-23
First Post:
2005-11-02
Brief Title:
Short-Term Effects of Medicinal Cannabis Therapy on Spasticity in Multiple Sclerosis
Sponsor:
Center for Medicinal Cannabis Research
Organization:
Center for Medicinal Cannabis Research
Study Overview
Official Title:
Short-Term Effects of Medicinal Cannabis Therapy on Spasticity in Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2006-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether or not smoked marijuana improves spasticity in patients with multiple sclerosis
Detailed Description:
Studies of cannabinoids for spasticity in MS have had mixed results but clinical studies have been small generally not properly controlled with results controversial and difficult to interpret Recently investigators in the UK and US tested the ability of cannabinoids to control spasticity and tremor symptoms of the MS-like disease experimental allergic encephalomyelitis in mice Baker et al 2000 The authors found that four different cannabinoids quantitatively ameliorated both tremor and spasticity in diseased mice thus providing rationale for patients reports of the therapeutic effects of cannabis in the control of their MS symptoms
The present study will be a randomized placebo-controlled crossover design of 30 patients who will be assessed before and after treatment for 3 consecutive days Phase I undergo washout-out for a total of 11 days and then cross over to either the placebo or active treatment phase Phase II depending on what they received during Phase I At each study visit patients will utilize a controlled puff procedure to help ensure stable intake Levin et al 1989
Comparisons A single dose of 4 THC marijuana cigarette each day for 3 days will be compared to a placebo administered under the same dosing conditions for the relief of spasticity drug tolerability and changes in global functioning and quality of life indices
The present study will be a randomized placebo-controlled crossover design of 30 patients who will be assessed before and after treatment for 3 consecutive days Phase I undergo washout-out for a total of 11 days and then cross over to either the placebo or active treatment phase Phase II depending on what they received during Phase I At each study visit patients will utilize a controlled puff procedure to help ensure stable intake Levin et al 1989
Comparisons A single dose of 4 THC marijuana cigarette each day for 3 days will be compared to a placebo administered under the same dosing conditions for the relief of spasticity drug tolerability and changes in global functioning and quality of life indices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 030002 | None | None | None |