Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain

• Status: Not yet recruiting
• Trial end date: 2027-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Veterans with diabetes are more likely than diabetic civilians to develop disabling chronic diabetic neuropathic pain (CDNP). Research on frontline treatments for CDNP (enhanced glycemic control, exercise, pharmacological agents), shows inconsistent outcomes and dissatisfaction among Veterans. Veterans and clinicians have shown significant interest in cannabis derivatives (THC, CBD) for neuropathic pain control, but there are no well-controlled trials guiding expectations for benefit and adverse outcomes associated with cannabis for CDNP. Because Veterans are likely to present with pain and pain-related polymorbidity significantly differing from that of civilians, a well-structured clinical trial of cannabinoids for Veterans with CDNP is vital.

The present phase II study will offer the first evidence describing the potential benefits and adverse effects of cannabinoids for CDNP in Veterans using a four-arm, double-blind, multisite randomized trial comparing THC, CBD, THC+CBD and placebo on neuropathic pain outcomes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Dronabinol; Nabiximols

Criteria

Inclusion Criteria:

• Able to provide written consent

• Veterans 21 years and older at the date of screening

• Meet NEURODIAB criteria for painful diabetic peripheral neuropathy

• Meet criteria for persistent, high-impact pain criteria.

• Presence of allodynia confirmed by one of the screening dynamic brush tests

Exclusion Criteria:

• Primary source of pain not related to diabetic neuropathy

• Hypersensitivity to THC, CBD, or THC/CBD

• Positive urine toxicology for THC-COOH on 2 consecutive visits before and including baseline assessment

• Unwilling to refrain from using cannabis or cannabis-based products through the entire duration of the study

• Diagnosis of DSM-5 Cannabis Use Disorder in the past 6 months

• Current DSM-5 diagnosis of cannabis use disorder, substance use disorder or serious psychiatric disorders

• Actual change or intent to change is greater than a 20% change (increase or decrease) in any other medication for pain or non-pharmacological treatment from 4 weeks before the screening appointment until completion of study (i.e., visit 13)

• Opioid doses > 400 mg MME (morphine milligram equivalent)

• Women who are pregnant or breastfeeding, or who intend to become pregnant in the 12 weeks from enrollment

• Any current unstable or concerning medical condition that would place the patient at increased risk, including hepatic, respiratory, immunological, cardiovascular, endocrine, or renal disease

• Need for immediate psychiatric hospitalization

• Enrolled in a medical marijuana program

• Federal employee