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NCT06190470 Clinical Trial

Effects of Marijuana on Neuropathic Pain and Spasticity in Spinal Cord Injury Patients

Spinal Cord Injury Clinical Trial

Official title:
Effects of Marijuana on Neuropathic Pain and Spasticity in Spinal Cord Injury Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06190470
Other study ID # HE651146
Secondary ID
Status Enrolling by invitation
Phase Phase 1
First received
Last updated
Start date January 2, 2024
Est. completion date June 30, 2024

Study information
Verified date March 2024
Source Khon Kaen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare effects of marijuana or cannabis on neuropathic pain and spasticity in spinal cord injury patients. The main question is: Does the cannabis product from KhonKaen University reduce neuropathic pain and spasticity in spinal cord injury patients? The research design is a crossover study. The participants will be randomly into 2 groups: group 1 and group 2. The participants received either cannabis or placebo for 2 weeks. After completing treatment, participants were swapped to the other group for 2 weeks, a wash-out period is 2 weeks. The outcome measurements are pain and spasticity.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 20
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 25 Years to 60 Years
Eligibility Inclusion Criteria: - Spinal cord injury more than 6 months - Neuropathic pain - Pain score > 3 - Do not response to standard medical treatment - Given inform consent Exclusion Criteria: - Allergy to cannabis - Unstable cardiovascular and pulmonary diseases - Chronic kidney and liver diseases - Psychological disease - Pregnancy or breastfeeding

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Cannabis
Cannabis product is from the extraction of the powdered, dried and mature pistillate inflorescences of Cannabis sativa L. containing THC 30mg/ml.
• Placebo
Placebo is similar to Cannabis product but do not contain THC.

Locations
Country Name City State
Thailand Faculty of Medicine Khon Kaen University Khon Kaen

Sponsors (1)
Lead Sponsor Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain score Visual analog scale 2 weeks
Secondary Spasticity Modified Asworth Score 2 weeks
Secondary Activities of daily living to assess functional outcome 2 weeks
Secondary Quality of life score WHO Bref Quality of life questionnaire 2 weeks
Secondary H-reflex Electrodiagnosis 2 weeks
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