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Cannabinoid
THC for HIV
Phase 1
Recruiting
Led By Deepak C D'Souza, MD
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 the ravlt will be administered prior to study drug administration at approximately 25 minutes after study drug administration.
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the effects of THC on HIV-infected and uninfected cells.
Who is the study for?
This trial is for adults with or without HIV. Participants must be in good health, have no recent drug use (including cannabis), and show good adherence to medications if HIV-positive. They should pass a physical exam, psychiatric interview, lab tests, ECG, and vital signs check.
What is being tested?
The study is testing how Delta-9-THC affects the immune system's genetic activity and cytokine production differently in people with and without HIV. It explores whether THC can cause changes through epigenetic mechanisms.
What are the potential side effects?
While not explicitly listed here, potential side effects of Delta-9-THC may include altered mental state, dizziness, dry mouth, changes in heart rate or blood pressure among others.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the ravlt will be administered prior to study drug administration at approximately 25 minutes after study drug administration.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the ravlt will be administered prior to study drug administration at approximately 25 minutes after study drug administration.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Cytokine Profile
Change in Cytokine Profile by THC between HIV-positive and HIV-negative Groups
Change in Gene Expression Alteration
+1 moreSecondary study objectives
Cannabinoid Relevant Molecules
Cannabis Subjective Effects
Change in total immediate recall on the RAVLT.
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Active Delta-9-THCExperimental Treatment1 Intervention
Active Delta-9-THC (0.03 mg/kg) administered intravenously.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active Delta-9-THC
2015
Completed Phase 1
~60
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,924 Previous Clinical Trials
3,031,618 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,587 Previous Clinical Trials
3,328,508 Total Patients Enrolled
Deepak C D'Souza, MDPrincipal InvestigatorYale University Professor of Psychiatry
5 Previous Clinical Trials
507 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am in good health overall, aside from HIV.I am in good mental and physical health.
Research Study Groups:
This trial has the following groups:- Group 1: Active Delta-9-THC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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