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Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain

ConditionsNeuropathic PainPeripheral Neuropathic Pain
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorVA Office of Research and Development

About this trial

Chronic neuropathic pain (CNP) is disabling. Research on frontline treatments for CNP, 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 CNP. 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 CNP is vital.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to provide written consent

Veterans 21 years and older at the date of screening

Meet diagnostic criteria for neuropathic pain as defined by the Neuropathic Pain Special Interest Group of the International Association for the Study of Pain (NeuPSIG)

Meet criteria for persistent, high-impact pain criteria.

Disqualifiers

Actively engaged in or planning to enter a program of non-pharmacological invasive intervention for pain at the time of enrollment

Peripheral neuropathy is not a primary source of neuropathic pain

Hypersensitivity to THC, CBD, or THC/CBD

Self-report of cannabis use during screening phase confirmed by positive urine toxicology for THC-COOH as measured and resulted at visit 5 before randomization

Trial design

Design model

Parallel

Treatments tested in this trial

  • THC (Syndros)

    Drug

    Participants will receive a target dose of 10mg per day of THC (Syndros).

  • CBD (Epidolex)

    Drug

    Participants will receive a target dose of 800 mg per day of CBD (Epidolex).

  • THC + CBD (Nabiximols)

    Drug

    Participants will receive a target dose of 10.8 mg / 10 mg per day of THC + CBD (Nabiximols).

  • Placebo

    Drug

    Placebo

Treatment groups

320 Participants
are divided into 4 treatment groups
Group A: THC (Syndros)Active comparator 2 interventions
Group B: CBD (Epidolex)Active comparator 2 interventions
Group C: THC + CBD (Nabiximols)Active comparator 2 interventions
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

To compare the short-term efficacy of THC, CBD, or THC+CBD vs Placebo on Neuropathic Pain as measured by the Numeric Rating Scale of Pain

The mean change in the weekly average of daily Numeric Rating Scale (NRS) pain score (0-10 scale; 0=no pain, 10=worst possible pain) from baseline to week 6.

Time frame
Baseline, Week 6

Secondary outcomes

1

To assess the efficacy of THC, CBD, or THC+CBD vs Placebo in pain quality (allodynia) as measured by the Quantitative Sensory Testing.

Allodynia measured by Quantitative Sensory Testing (QST) (0-10 scale; 0=no pain, 10=worst possible pain)

Time frame
Baseline, Week 2, Week 4, Week 6, Week 8
2

To assess the efficacy of THC, CBD, or THC+CBD vs Placebo in disability and function as measured by the Neuropathic Pain Scale.

Neuropathic Pain Scale (NPS) total score; 7 different questions/sensations (for each individual item 0-10 scale; 0= not present/no pain, 10= most sensation). Individual scores analyzed separately for pain quality and mean score analyzed for overall neuropathic pain).

Time frame
Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
3

To assess the efficacy of THC, CBD, or THC+CBD vs Placebo in disability and function as measured by the Gait Speed Test

Distance walked (meters)/time (seconds) measured by Gait Speed Test (lower score = worse, higher score =better)

Time frame
Baseline, Week 4, Week 8
4

To assess the efficacy of THC, CBD, or THC+CBD vs Placebo in mean changes in perceived improvement as measured by the Patient Global Impression of Change

Patient Global Impression of Change (PGIC) 1-7 point ordinal scale assessed (1 = worse, 7 = better)

Time frame
Baseline, Week 2, Week 4, Week 6, Week 8

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov
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