A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effects and Mechanisms of a High CBD Cannabis Extract (BRC-002) for the Treatment of Pain and Health in Complex Regional Pain Syndrome

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 75
Healthy Volunteers: f
View:

• 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)

• Are not currently using any type of cannabis, including hemp or CBD

• Currently 30 days cannabis free

• Participants with ongoing CRPS \[Type 1 or Type 2)\] for at least 3 months prior to participation (medical record confirmed)

• Agrees not to use cannabis, including hemp or CBD, outside of the study during participation in the study

• Agrees not to use opioids or barbiturates during participation in the study

Locations
United States
California
Altman Clinical and Translational Research Institute
RECRUITING
La Jolla
University of California, San Diego
RECRUITING
San Diego
Contact Information
Primary
Fadel Zeidan, PhD
fzeidan@health.ucsd.edu
858-246-8341
Backup
Yasmeen Esshaki, MS
yesshaki@health.ucsd.edu
858-246-8341
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2029-06-01
Participants
Target number of participants: 52
Treatments
Placebo_comparator: Placebo Comparator: 1 Placebo
Half of the patients will receive PO placebo
Experimental: Experimental: Active
Drug: BRC-002 (High Cannabidiol Botanical Extract) 100 mg/mL
Related Therapeutic Areas
Sponsors
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov