Medium CBD session for Complex Regional Pain Syndrome

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
UC Center for Medicinal Cannabis Research, UC San Diego, San Diego, CAComplex Regional Pain Syndrome+2 MoreCannabis - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is looking at the acute effects of cannabis constituents on HIV-NP, long-term effects of cannabis use, and the impact of cannabis on endocannabinoid function in people living with HIV-NP.

Eligible Conditions
  • HIV-associated Neuropathy
  • Complex Regional Pain Syndrome
  • Cannabis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: participants will be queried on a daily basis for six months using text messaging

Hour 4
Phase 1 - Marijuana subscale (M-scale) of the Addiction Research Center Inventory (ARCI)
Phase 1 - Neuropsychological Assessment Battery
Heart rate
Pain
Phase 1 - store plasma samples for evaluation of THC, CBD, and endocannabinoid system biomarkers
Phase 1 - von Frey test
Hour 4
Phase 1 - Patient Global Impression of Change (PGIC)
participants will be queried on a daily basis for six months using text messaging
Pain

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

Medium CBD session
1 of 3
High CBD session
1 of 3
Low CBD session
1 of 3

Active Control

120 Total Participants · 3 Treatment Groups

Primary Treatment: Medium CBD session · No Placebo Group · Phase 2

Medium CBD session
Drug
ActiveComparator Group · 1 Intervention: Cannabis · Intervention Types: Drug
High CBD session
Drug
ActiveComparator Group · 1 Intervention: Cannabis · Intervention Types: Drug
Low CBD session
Drug
ActiveComparator Group · 1 Intervention: Cannabis · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: participants will be queried on a daily basis for six months using text messaging

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,036 Previous Clinical Trials
1,825,433 Total Patients Enrolled
Brook L Henry, PhDPrincipal InvestigatorUniversity of California, San Diego

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

Could you explain what the risks are for a person taking CBD?

"While there is some data supporting the safety of Medium CBD, as this is only a Phase 2 trial, none of it supports efficacy. Therefore, it received a score of 2." - Anonymous Online Contributor

Unverified Answer

Have there been similar trials like this one in the past?

"Currently, there are 35 on-going trials for Medium CBD session in 5 different countries. The first trial was conducted 6 years ago in 2015 and completed both its Phase 2 & 3 drug approval stages. Since then, 61 more trials have been successfully finished." - Anonymous Online Contributor

Unverified Answer

Are there presently any available slots for this clinical trial?

"The trial you are referring to is still recruiting patients, as indicated by the listing on clinicaltrials.gov. This study was first posted on July 1st, 2018 and has since been updated on January 10th, 2022." - Anonymous Online Contributor

Unverified Answer

How many people are joining this clinical trial?

"That is correct. The listing on clinicaltrials.gov does show that the research team is currently looking for study subjects. This particular trial was first made public on July 1st, 2018 and received its most recent update on January 10th, 2022. A total of 120 individuals will be enrolled at a single location." - Anonymous Online Contributor

Unverified Answer

Can you please compare and contrast this clinical trial with others involving Medium CBD session?

"There are currently 35 ongoing studies investigating the effects of Medium CBD session. Out of these, 3 are in Phase 3. Most trials originate from Hartford, Connecticut but there are 51 different locations running these sorts of tests." - Anonymous Online Contributor

Unverified Answer

What are the primary goals of this research project?

"The primary outcome of this six-month long clinical trial will be daily pain intensity levels as reported by participants, evaluated using an 11-point numerical scale. Secondary objectives includePhase 1 - the Neuropsychological Assessment Battery, Phase 1 - the von Frey test, and Phase 1 - the Marijuana subscale (M-scale) of the Addiction Research Center Inventory (ARCI)." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.