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

Phase 1

• Conditions: Spinal Cord Injury
• Interventions: Drug: Placebo; Drug: Cannabis

• Registration Number: NCT06190470
• Lead Sponsor: Khon Kaen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2023-12-19
• Study Start: 2024-01-02
• Study First Posted: 2024-01-05
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-08
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	The participants will receive placebo product manufactured by Faculty of Pharmaceutical Science KhonKaen University for 2 weeks. The participants will gradually increase using the product starting from 1 drop per day sublingually and can increase using not more than 1 drop per day,
Experimental group	Cannabis	The participants will receive cannabis product for 2 weeks. The participants will receive the cannabis product (THC 30mg / 1 ml) manufactured by Faculty of pharmaceutical science KhonKaen University. The participants will gradually increase using the product starting from 1 drop (1.5 mg THC) per day sublingually and can increase using not more than 1 drop per day, until pain or spasticity can be controlled.

Primary Outcome Measures

Name	Time	Method
Pain score	2 weeks	Visual analog scale

Secondary Outcome Measures

Name	Time	Method
Spasticity	2 weeks	Modified Asworth Score
Activities of daily living	2 weeks	to assess functional outcome
Quality of life score	2 weeks	WHO Bref Quality of life questionnaire
H-reflex	2 weeks	Electrodiagnosis

Trial Locations

Locations (1)

Faculty of Medicine Khon Kaen University; 🇹🇭 Khon Kaen, Thailand