Effects of Vaporized Marijuana on Neuropathic Pain

University of California (UC) Davis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Peripheral Neuropathy; Multiple Sclerosis; Reflex Sympathetic Dystrophy; Neuropathic Pain; Post-herpetic Neuralgia; Spinal Cord Injury

Treatments: Drug: Low dose cannabis; Drug: Cannabis; Drug: Mild dose cannabis

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01037088

C06-DA-119 (Other Grant/Funding Number)

200614658

Details and patient eligibility

About

This study theorized that a low dose of vaporized cannabis could alleviate nerve injury pain.

Full description

We conducted a double-blind, placebo-controlled, crossover study evaluating the analgesic efficacy of vaporized cannabis in subjects, the majority of whom were experiencing neuropathic pain despite traditional treatment. Thirty-nine patients with central and peripheral neuropathic pain underwent a standardized procedure for inhaling medium-dose (3.53%), low-dose (1.29%), or placebo cannabis with the primary outcome being visual analog scale pain intensity. Psychoactive side effects and neuropsychological performance were also evaluated.

Enrollment: 44 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age greater than 18 and less than 70
• Visual Analogue Scale (VAS pain intensity) greater than 3/10
• A negative urine drug screening test, i.e., no evidence of IV drug abuse
• Neuropathic pain due to reflex sympathetic dystrophy, peripheral neuropathy, post-herpetic neuralgia, post-stroke pain, multiple sclerosis or spinal cord injury

Exclusion criteria

• Presence of another painful condition of greater severity than the neuropathic pain condition which is being studied.
• Subjects with moderate-severe major depression, bipolar/mania, bipolar II/hypomania and schizophrenia or schizoaffective disorder.
• Unstable Type 1 or 2 diabetes defined as blood glucose more than 156 mg/dl
• History of traumatic brain injury
• Uncontrolled medical condition, including coronary artery disease, hypertension, cerebrovascular disease, asthma, tuberculosis (TB), chronic obstructive pulmonary disease (COPD), opportunistic infection, malignancy requiring active treatment, active substance abuse (alcohol or injection drugs).
• Current use of marijuana (e.g., within 30 days of randomization)
• Pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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44 participants in 3 patient groups, including a placebo group

Mild dose cannabis

Experimental group

Description:

3.53% THC by weight

Treatment:

Drug: Mild dose cannabis

Low dose cannabis

Experimental group

Description:

1.29% THC by weight

Treatment:

Drug: Low dose cannabis

Placebo cannabis

Placebo Comparator group

Description:

placebo marijuana

Treatment:

Drug: Cannabis