Chronic spinal cord injury Intractable spasticity Pain Sleep dysfunction spinal cord injury spasticity pain sleep cannabinoids
Conditions
Interventions
1:1 THC:CBD oil, titrate from THC 2 to 12 mg/day,Placebo oil with titration
Experimental Drug,Placebo Comparator Drug
1:1 THC:CBD oil,Placebo oil
Sponsors
The Government Pharmaceutical Organization of Thailand
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Persons with traumatic spinal cord injury Age between 20-65 years Able to communicate in Thai Onset of injury more than 1 year Any level and severity of injury Having intractable systemic spasticity (MAS > 2 despite receiving maximum tolerable oral antispastic drugs)
Exclusion criteria
Exclusion criteria: Age < 20 years Abnormal blood test Severe Co-morbid disease Pregnancy or breast feeding History of psychotic disorder First degree relative with schizophrenia History of suicidal attempt or current suicidal idea Currently on Carbamazepine, Phenytoin, Fluoxetine, Clobazam, Valproic acid Currently use cannabinoids/cannabis Positive urine cannabinoids screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spasticity at 1 month after intervention Ashworth scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Neural excitability at 1 month after intervention H/M ratio | — |
Countries
Thailand
Contacts
Public ContactSintip Pattanakuhar
Chiang Mai University
Outcome results
None listed