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Cannabinoid

Low CBD session for Cannabis

Phase 2

Waitlist Available

Led By Brook L Henry, PhD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participants will be queried on a daily basis for six months using text messaging

Awards & highlights

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

Cannabis
Neuropathy
Complex Regional Pain Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participants will be queried on a daily basis for six months using text messaging

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participants will be queried on a daily basis for six months using text messaging

This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will be queried on a daily basis for six months using text messaging for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain

Secondary outcome measures

Phase 1 - Marijuana subscale (M-scale) of the Addiction Research Center Inventory (ARCI)

Phase 1 - Neuropsychological Assessment Battery

Phase 1 - Patient Global Impression of Change (PGIC)

+3 more

Trial Design

3Treatment groups

Active Control

Group I: Low CBD sessionActive Control1 Intervention

In the morning, participants will inhale 8 puffs of vaporized cannabis containing 1.6% THC + 0.09 CBD. They will then undergo experimental testing as described below under Outcome Measures.

Group II: Medium CBD sessionActive Control1 Intervention

In the morning, participants will inhale 8 puffs of vaporized cannabis 4 puffs will contain 1.6% THC + 0.09 CBD and 4 puffs will contain 1.73% THC + 5.4% CBD. They will then undergo experimental testing as described below under Outcome Measures.

Group III: High CBD sessionActive Control1 Intervention

In the morning, participants will inhale 8 puffs of vaporized cannabis containing 1.73% THC + 5.4% CBD. They will then undergo experimental testing as described below under Outcome Measures.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,120 Previous Clinical Trials

1,521,363 Total Patients Enrolled

4 Trials studying Cannabis

343 Patients Enrolled for Cannabis

Brook L Henry, PhDPrincipal InvestigatorUniversity of California, San Diego

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Cannabis and Endocannabinoids on HIV Neuropathic Pain

Brook Henry 2018. "Effect of Cannabis and Endocannabinoids on HIV Neuropathic Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03099005.