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CBD for Opioid Addiction

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
Capable of providing informed consent in English
Having chronic pain, uniformly operationalized as grade II (high-intensity) non-cancer pain for ≥ 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 hours
Awards & highlights

Study Summary

This trial is testing if CBD could help people with an opioid addiction and chronic pain.

Who is the study for?
This trial is for adults aged 18-70 with chronic pain and opioid use disorder, currently on stable methadone or buprenorphine treatment. Participants must not have other substance use disorders (except tobacco), be free from severe psychiatric conditions, and women must not be pregnant or breastfeeding and should use birth control.Check my eligibility
What is being tested?
The study tests the safety of Cannabidiol (CBD) as an additional treatment for opioid addiction and chronic pain in patients receiving medication-assisted therapy. It's a controlled study where CBD's effects on pain relief and craving reduction are measured against a placebo.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any adverse reactions to CBD which could include fatigue, changes in appetite, gastrointestinal discomfort, or potential interactions with their current medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can understand and sign the consent form in English.
Select...
I have had severe non-cancer pain for at least 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Agitation Calmness Evaluation Scale (ACES)
Mini-mental state examination
Systematic Assessment of Side Effects (SAFTEE)
Secondary outcome measures
Quantitative Sensory Testing (QST)
Other outcome measures
The Heroin Craving Questionnaire - Short Form 14 (HCQ-SF-14)

Trial Design

3Treatment groups
Active Control
Group I: CBD 400mgActive Control1 Intervention
CBD 400mg
Group II: CBD 800mgActive Control1 Intervention
CBD 800mg
Group III: CBD 1200mgActive Control1 Intervention
CBD 1200mg

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,469 Previous Clinical Trials
2,619,403 Total Patients Enrolled
Yale UniversityLead Sponsor
1,851 Previous Clinical Trials
2,738,315 Total Patients Enrolled
Joao De Aquino, M.D.Principal InvestigatorYale University
2 Previous Clinical Trials
76 Total Patients Enrolled

Frequently Asked Questions

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

How many participants are being enrolled for this medical experiment?

"Affirmative. Data published on clinicaltrials.gov declares that this medical trial, which was initially posted on December 8th 2021, is actively searching for candidates to enrol in the study. 6 patients need to be selected from 1 designated location."

Answered by AI

Am I eligible to contribute to this experiment?

"The requirements for enrollment in this addiction-focused clinical trial involve being between 18 and 70 years of age. 6 volunteers are needed to complete the study."

Answered by AI

Are individuals over 30 years of age being enrolled for this experiment?

"According to the eligibility criteria, this clinical trial is open for individuals aged between 18 and 70. There are 20 trials catering specifically to minors and 103 studies designed with seniors in mind."

Answered by AI

Has research been done on the effectiveness of CBD 400mg treatment?

"As of today, there are 79 separate experiments being conducted on CBD 400mg. Of these studies, 16 have progressed to the third phase and they can be found in Ribeirao Preto, Sao Paulo or any one of the 290 other locations that host trials for this medication."

Answered by AI

Are additional participants currently being accepted for this research endeavor?

"Affirmative. Clinicaltrials.gov has the pertinent information that this research is currently requiring recruiting participants, with 6 individuals needed from one medical facility. The trial was first posted on December 8th 2021 and was last updated October 12th 2022."

Answered by AI
~0 spots leftby Jun 2024