← Back to Search

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

Study 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.Check my eligibility

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.See study design

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the ravlt will be administered prior to study drug administration at approximately 25 minutes after study drug administration. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Cytokine Profile

Change in Cytokine Profile by THC between HIV-positive and HIV-negative Groups

Change in Gene Expression Alteration

+1 more

Secondary outcome measures

Cannabinoid Relevant Molecules

Cannabis Subjective Effects

Change in total immediate recall on the RAVLT.

+1 more

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

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,852 Previous Clinical Trials

2,738,401 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,469 Previous Clinical Trials

2,619,369 Total Patients Enrolled

Deepak C D'Souza, MDPrincipal InvestigatorYale University Professor of Psychiatry

5 Previous Clinical Trials

507 Total Patients Enrolled

Media Library

Delta-9-THC (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT04920539 — Phase 1

Human Immunodeficiency Virus Infection Research Study Groups: Active Delta-9-THC

Human Immunodeficiency Virus Infection Clinical Trial 2023: Delta-9-THC Highlights & Side Effects. Trial Name: NCT04920539 — Phase 1

Delta-9-THC (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04920539 — Phase 1

Frequently Asked Questions

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

Is Active Delta-9-THC a reliable treatment with no potential health risks?

"With only preliminary data available to support its safety and efficacy, Active Delta-9-THC was rated a 1 on our team's scale."

Answered by AI

To what extent is enrollment for this research initiative progressing?

"Indeed, the evidence on clinicaltrials.gov suggests that recruitment of participants for this trial is still ongoing. It was initially uploaded to the website on February 8th 2022 and last updated on August 2nd 2022. 40 patients are required from one single site."

Answered by AI

Am I qualified to partake in this research program?

"To be eligible, prospective participants must have an HIV diagnosis and fall in the 18 to 65 year old age range. The total number of enrollees is set at 40 patients."

Answered by AI

What additional research has been completed that includes Active Delta-9-THC?

"Currently, 38 clinical studies are underway to examine the efficacy of Active Delta-9-THC. Out of those trials, 6 have advanced to phase 3 and 90 locations across Belmont, Massachusetts offer access for participants."

Answered by AI

Is there any availability for individuals to participate in this clinical experiment?

"Affirmative. Clinicaltrials.gov reports that the trial, which was initially posted on February 8th 2022, is presently recruiting participants. Forty patients need to be enrolled from a single medical site."

Answered by AI

Does this research accept elderly participants?

"According to the regulations of this medical trial, those aged 18-65 are eligible for enrolment."

Answered by AI

What goals has this clinical research endeavor set out to realize?

"The impact of this clinical trial will be gauged by evaluating changes in gene expression alteration. Secondary outcomes, such as alterations to immediate recall on the Rey Auditory Verbal Learning Task (RAVLT), cannabinoid relevant molecules present in blood samples, and subjective feelings associated with cannabis use, will also be taken into account. Blood tests shall take place prior to study drug infusion and at 70, 140, and 300 minutes post-infusion while self-reported visual analog scales are used to assess the intensity of feeling states related to cannabis effects."

Answered by AI

What medical applications does Active Delta-9-THC have?

"Typically, weight loss is treated with Active Delta-9-THC. Additionally, this therapeutic intervention has been shown to be beneficial for those who lack a response to more traditional treatments such as pharmacotherapy and conventional therapy, as well as in cases of reduced appetite."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

In Vivo Study of THC-induced Immune-genome Changes at Single Cell Solution in HIV-infected Humans

Deepak C. D'Souza 2022. "In Vivo Study of THC-induced Immune-genome Changes at Single Cell Solution in HIV-infected Humans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04920539.

All > Hiv Infection > Cannabis