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Cannabinoid

Cannabidiol for Opioid Use Disorder and Chronic Pain

Q: May I be included as a participant in this research project?

This clinical trial is recruiting 40 individuals between 18 and 70 with long-term musculoskeletal pain. To qualify, candidates must be free from any medical condition that would prevent their participation, not pregnant or breastfeeding, have no substance use disorder within the past year (not including opioid <a href="https://www.withpower.com/clinical-trials/addiction">addiction</a> or tobacco usage), and meet DSM-5 criteria for <a href="https://www.withpower.com/clinical-trials/chronic-pain">chronic pain</a>.

Q: Are there any existing studies which focus on the effects of CBD 1200mg?

Presently, 79 clinical studies are being conducted on <a href="https://www.withpower.com/clinical-trials/cbd">CBD</a> 1200mg with 16 of these in Phase 3. The city of Ribeirao Preto located in Sao Paulo is hosting a few trials for this medication, but there are 290 other sites across the globe where it can be accessed as part of an <a href="https://www.withpower.com/clinical-trials/experimental">experimental</a> trial.

Q: What is the highest permissible number of participants for this experiment?

Affirmative. Clinical trials' website reveals that this medical exploration, which was initially posted on November 15th 2022, is actively searching for volunteers. About 40 subjects need to be enrolled from 1 different facility.

Q: Does this trial accept minors as participants?

As detailed in the inclusion criteria, those over 18 and under 70 years of age can partake in this clinical trial.

Q: Are there any unfilled slots available in this research study?

Indeed, information hosted on clinicaltrials.gov indicates that this medical research is actively recruiting participants. It was initially posted in November 15th 2022 and has since been updated to as recently as November 21st 2022. They aim to recruit 40 individuals from a single site.

Phase < 1

Recruiting

Led By Joao De'Aquino, M.D.

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

Having chronic pain, uniformly operationalized as grade II (high-intensity) non-cancer musculoskeletal pain for ≥ 6 months

Diagnosed with OUD and currently enrolled in methadone or buprenorphine maintenance treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 weeks

Awards & highlights

Study Summary

This trial will test the effects of CBD on social anxiety.

Who is the study for?

This trial is for adults aged 18-70 with chronic high-intensity musculoskeletal pain and opioid use disorder, who are stable on opioid maintenance treatment. Participants must be able to consent in English, not have major medical issues or unstable psychiatric conditions, and women must not be pregnant or breastfeeding.Check my eligibility

What is being tested?

The study tests the effects of Cannabidiol (CBD) at different doses (1200mg, 800mg, and 400mg) compared to a saline placebo in managing chronic pain and opioid dependency. It's a double-blind study where neither participants nor researchers know who gets CBD or placebo during four sessions after an initial screening.See study design

What are the potential side effects?

While specific side effects aren't listed here, CBD can commonly cause tiredness, diarrhea, changes in appetite/weight. Since it's being tested against saline (a harmless substance), any additional side effects observed could help understand CBD's impact.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had severe non-cancer related muscle or bone pain for 6 months or more.

Select...

I am diagnosed with opioid use disorder and am on methadone or buprenorphine.

Select...

I am not pregnant, not breastfeeding, and using birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Quantitative Sensory Testing (QST)

Systematic Assessment for Treatment Emergent Events (SAFTEE)

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: CBD 400mgActive Control1 Intervention

CBD 400 mg

Group II: CBD 1200mgActive Control1 Intervention

CBD 1200mg

Group III: CBD 800mgActive Control1 Intervention

CBD 800mg

Group IV: SalinePlacebo Group1 Intervention

saline

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Connecticut Healthcare SystemFED

81 Previous Clinical Trials

6,670 Total Patients Enrolled

3 Trials studying Chronic Pain

320 Patients Enrolled for Chronic Pain

Yale UniversityLead Sponsor

1,851 Previous Clinical Trials

2,738,173 Total Patients Enrolled

14 Trials studying Chronic Pain

2,690 Patients Enrolled for Chronic Pain

National Institute on Drug Abuse (NIDA)NIH

2,468 Previous Clinical Trials

2,619,309 Total Patients Enrolled

55 Trials studying Chronic Pain

82,920 Patients Enrolled for Chronic Pain

Media Library

Cannabidiol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT04587791 — Phase < 1

Chronic Pain Research Study Groups: CBD 400mg, Saline, CBD 1200mg, CBD 800mg

Chronic Pain Clinical Trial 2023: Cannabidiol Highlights & Side Effects. Trial Name: NCT04587791 — Phase < 1

Cannabidiol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04587791 — Phase < 1

Frequently Asked Questions

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

May I be included as a participant in this research project?

"This clinical trial is recruiting 40 individuals between 18 and 70 with long-term musculoskeletal pain. To qualify, candidates must be free from any medical condition that would prevent their participation, not pregnant or breastfeeding, have no substance use disorder within the past year (not including opioid addiction or tobacco usage), and meet DSM-5 criteria for chronic pain."

Answered by AI

Are there any existing studies which focus on the effects of CBD 1200mg?

"Presently, 79 clinical studies are being conducted on CBD 1200mg with 16 of these in Phase 3. The city of Ribeirao Preto located in Sao Paulo is hosting a few trials for this medication, but there are 290 other sites across the globe where it can be accessed as part of an experimental trial."

Answered by AI

What is the highest permissible number of participants for this experiment?

"Affirmative. Clinical trials' website reveals that this medical exploration, which was initially posted on November 15th 2022, is actively searching for volunteers. About 40 subjects need to be enrolled from 1 different facility."

Answered by AI

Does this trial accept minors as participants?

"As detailed in the inclusion criteria, those over 18 and under 70 years of age can partake in this clinical trial."

Answered by AI

Are there any unfilled slots available in this research study?

"Indeed, information hosted on clinicaltrials.gov indicates that this medical research is actively recruiting participants. It was initially posted in November 15th 2022 and has since been updated to as recently as November 21st 2022. They aim to recruit 40 individuals from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cannabidiol in Opioid Use Disorder and Chronic Pain

Joao De Aquino 2021. "Cannabidiol in Opioid Use Disorder and Chronic Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04587791.

All > Opioid Dependence > Epidiolex