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

Khon Kaen University

Status and phase: Invitation-only; Phase 1

Conditions: Spinal Cord Injury

Treatments: Drug: Placebo; Drug: Cannabis

Study type: Interventional

Funder types: Other

Identifiers

NCT06190470

HE651146

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

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.

Treatment:

Drug: Cannabis

Placebo group

Placebo Comparator group

Description:

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,

Treatment:

Drug: Placebo