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

NCT ID: NCT06190470

Last Updated: 2024-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-02

Study Completion Date

2024-06-30

Brief Summary

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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

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Conditions

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Spinal Cord Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental group

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.

Group Type EXPERIMENTAL

Cannabis

Intervention Type DRUG

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

Placebo group

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,

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Cannabis

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Marijuana Control/ No cannabis

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Khon Kaen University

OTHER

Sponsor Role lead

Responsible Party

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Nuttaset Manimmanakorn

Rehabilitation Medicine Department Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nuttaset Manimmanakorn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rehabilitation Medicine Department, Faculty of Medicine, KhonKaen University

Locations

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Faculty of Medicine Khon Kaen University

Khon Kaen, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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HE651146

Identifier Type: -

Identifier Source: org_study_id

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