Health TrialsbyHealthPanel

The Effects and Mechanisms of a High CBD Cannabis Extract (BRC-002) for the Treatment of Pain and Health in Complex Regional Pain Syndrome

ConditionComplex Regional Pain Syndrome
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-75
SponsorUniversity of California, San Diego

About this trial

The aim of this trial is to determine the potential effects and mechanisms of cannabinoid-induced pain relief in complex regional pain syndrome (CRPS). Multiple psychophysical approaches will be conducted in conjunction with psychological and inflammatory marker testing to determine if and how cannabinoids produce stabilized improvement in CRPS-related pain and comorbidities.

The trial consisted of a pre-treatment screening period, six-week treatment period and a two-week follow-up.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of signed and dated informed consent form.

Are between 21-75 years old

Ability to communicate in English

Volunteers with no previous medical history (e.g., cardiac or pulmonary disease)

Disqualifiers

Fail cannabis screening

Active pulmonary disease

Allergy or past adverse effects or negative past experiences from cannabis

Positive urine drug test for THC, barbiturates, opioids, oxycodone, or methadone prior to study session 1 or session 2

Trial design

Design model

Parallel

Treatments tested in this trial

  • BRC-002

    Drug

    BRC-002 is a non-scheduled cannabidiolic (CBD) formulation (\<.3% THC). The cannabinoids in BRC-002 are naturally biosynthesized within the Cannabis sativa L. plant as acidic forms of CBD (cannabidiolic acid; CBDA), THC (tetrahydrocannabinolic acid; THCA) and other minor cannabinoids.

  • BRC-002 Placebo

    Drug

    Oral solution of mono-, di-, and triglycerides

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Placebo Comparator: 1 PlaceboPlacebo comparator 1 intervention
Group B: Experimental: ActiveExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in complex regional pain syndrome pain and heat pain measured with VAS

Change from baseline in pain intensity and unpleasantness ratings using an 11-point Visual Analog Scale in response to heat and ongoing CRPS pain

Time frame
Day 1 - Day 42

Secondary outcomes

1

Pain Inventory Measure

Change from baseline in The Brief Pain Inventory

Time frame
Day 1 - Day 42
2

Depression Measure

Change from baseline in Beck Depression

Time frame
Day 1 - Day 42
3

Sleep Measure

Change from baseline in Pittsburgh Sleep Quality Index

Time frame
Day 1 - Day 42
4

Interleukin 6

Change from baseline in Interleukin 6

Time frame
Day 1 - Day 42

Other outcomes

Sponsors and contacts

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

University of California, San Diego

Lead sponsor

Source ClinicalTrials.gov
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