Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain
Status:
Not yet recruiting
Trial end date:
2027-06-30
Target enrollment:
Participant gender:
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.