Clinical trial

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

NCT06190470

Name

HE651146

Description

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.

Trial arms

Trial start

2024-01-02

Estimated PCD

2024-06-30

Trial end

2024-06-30

Phase

Early phase I

Treatment

Cannabis

Cannabis product is from the extraction of the powdered, dried and mature pistillate inflorescences of Cannabis sativa L. containing THC 30mg/ml.

Arms:

Experimental group

Other names:

Marijuana

Placebo

Placebo is similar to Cannabis product but do not contain THC.

Arms:

Placebo group

Other names:

Control/ No cannabis

Size

Primary endpoint

Pain score

2 weeks

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

Updated at

2024-03-08

1 organization

1 product

1 drug

1 indication

Organization

Product

Indication

Drug