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

NCT06190470 | Enrolling By Invitation Phase 1

• 1 other identifier: HE651146
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

Cannabis; Marijuana; Spinal cord injury; Pain; Spasticity

Outcome Measures

Primary Outcomes (1)

• Pain score

  Visual analog scale

  2 weeks

Secondary Outcomes (4)

• Spasticity

  2 weeks

• Activities of daily living

  2 weeks

• Quality of life score

  2 weeks

• H-reflex

  2 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Drug: Cannabis

Placebo group

PLACEBO COMPARATOR

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,

Drug: Placebo

Interventions

Cannabis DRUG

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

Also known as: Marijuana

Experimental group

Placebo DRUG

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

Also known as: Control/ No cannabis

Placebo group

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Spinal cord injury more than 6 months
• Neuropathic pain
• Pain score \> 3
• Do not response to standard medical treatment
• Given inform consent

You may not qualify if:

• Allergy to cannabis
• Unstable cardiovascular and pulmonary diseases
• Chronic kidney and liver diseases
• Psychological disease
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Faculty of Medicine Khon Kaen University

Khon Kaen, 40002, Thailand

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Marijuana Abuse; Pain; Muscle Spasticity

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Study Officials

• Nuttaset Manimmanakorn, MD, PhD

  Rehabilitation Medicine Department, Faculty of Medicine, KhonKaen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rehabilitation Medicine Department Faculty of Medicine

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: January 2, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: beginning 3 months and ending 5 years following article published
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

TH (1)