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Cannabinoid

Medical Marijuana for Pain Management

Phase 1
Waitlist Available
Research Sponsored by Yale University
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 from day 1 to day 7
Awards & highlights

Study Summary

This trial will study the effects of CBD, THC, and a placebo on stress and pain responses.

Who is the study for?
This trial is for adults with a BMI of 18-30 who use cannabis recreationally and have chronic pain stabilized on medication. They must not have any substance use disorders, psychiatric conditions needing urgent care, or be taking certain medications. Women who are pregnant or nursing, or with specific menstrual disorders cannot join.Check my eligibility
What is being tested?
The study tests the safety and effects of two different doses of natural CBD/THC oral tablets compared to a placebo on stress and pain responses. Participants will take single doses as well as repeated dosing to assess changes in their body's reaction over time.See study design
What are the potential side effects?
Potential side effects may include typical reactions associated with cannabis such as dizziness, dry mouth, altered mental state, fatigue, and possibly an increased risk of developing a dependency if used frequently over time.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 to day 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 to day 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average Systolic and Diastolic Blood Pressure
Average heart rate
Secondary outcome measures
Total Pain Score

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Dose 2Experimental Treatment1 Intervention
Participants will receive the second most tolerable CBD/THC dose with repeated dosing for 7 days. On day 1 and 6/7 of the 7-day dosing, subjects will complete laboratory sessions
Group II: Active Dose 1Experimental Treatment1 Intervention
Participants will receive the most tolerable CBD/THC dose with repeated dosing for 7 days. On day 1 and 6/7 of the 7-day dosing, subjects will complete laboratory sessions.
Group III: Matching PlaceboPlacebo Group1 Intervention
Participants will receive a placebo with repeated dosing for 7 days. On day 1 and 6/7 of the 7-day dosing, subjects will complete laboratory sessions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dronabinol
FDA approved
Medical Cannabis
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Connecticut Pharmaceutical SolutionsUNKNOWN
Yale UniversityLead Sponsor
1,848 Previous Clinical Trials
2,737,794 Total Patients Enrolled
14 Trials studying Pain
3,306 Patients Enrolled for Pain

Media Library

Active CBD/THC Dose 1 (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT04226690 — Phase 1
Pain Research Study Groups: Active Dose 2, Matching Placebo, Active Dose 1
Pain Clinical Trial 2023: Active CBD/THC Dose 1 Highlights & Side Effects. Trial Name: NCT04226690 — Phase 1
Active CBD/THC Dose 1 (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04226690 — Phase 1

Frequently Asked Questions

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

Is this research program accepting participants aged over 20 years?

"Eligibility for this research project requires that participants be within the age range of 21 to 60 years old."

Answered by AI

May I be accepted as a participant in this clinical trial?

"The criteria for acceptance into this clinical trial is based on age (21 to 60) and the presence of pain. Approximately 36 participants are being accepted at present."

Answered by AI

Has the regulatory body sanctioned Active CBD/THC Dose 1?

"Our team at Power gives Active CBD/THC Dose 1 an assessment score of 1, as this is a Phase 1 trial. Consequently, there is only limited evidence indicating its safety and efficacy."

Answered by AI

Are there any opportunities to participate in this research trial at present?

"Clinicaltrials.gov has reported that this medical study is no longer enrolling patients, having first been posted on November 15th 2022 and last edited on October 27th 2022. Fortunately, there are 453 other clinical trials with active recruitment of participants at the present moment."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
The Yale Stress Center: Yale University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Safety and Effects on Responses to Stress and Pain of Natural Medical Marijuana Products
RAJITA SINHA 2022. "Safety and Effects on Responses to Stress and Pain of Natural Medical Marijuana Products". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04226690.
~10 spots leftby Apr 2025
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