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Cannabinoid

Active Delta-9-THC for Healthy Subjects (THC-Preg Trial)

Phase 1
Waitlist Available
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
Exposed to cannabis at least once in lifetime.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 25 minutes after start of thc infusion
Awards & highlights

THC-Preg Trial Summary

This trial will study the effects of a hormone on the short-term mental effects of marijuana.

THC-Preg Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have used cannabis at least once in your life.

THC-Preg Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~25 minutes after start of thc infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 25 minutes after start of thc infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Secondary outcome measures
Clinician Administered Dissociative Symptoms Scale (CADSS)
Cognitive Test Battery
Psychotomimetic States Inventory (PSI)
+1 more

THC-Preg Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Placebo Delta-9-THC and Active PregnenoloneExperimental Treatment2 Interventions
Group II: Active Delta-9-THC and Placebo PregnenoloneExperimental Treatment2 Interventions
Group III: Active Delta-9-THC and Active PregnenoloneExperimental Treatment2 Interventions
Group IV: Placebo Delta-9-THC and Placebo PregnenolonePlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dronabinol
FDA approved
Pregnenolone
FDA approved
Placebo
1995
Completed Phase 3
~2670

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
1,837 Previous Clinical Trials
2,728,375 Total Patients Enrolled
Deepak C D'Souza, MDPrincipal InvestigatorYale University
5 Previous Clinical Trials
509 Total Patients Enrolled

Frequently Asked Questions

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

What criteria must a potential participant meet in order to be approved for this clinical trial?

"This medical study is actively seeking 38 participants, aged 18 to 55 with a history of cannabis exposure. As healthy subjects (HS), they must meet the criteria specified by the clinical trial protocol."

Answered by AI

What is the recruitment size of this clinical trial?

"This study is no longer enrolling patients. It was initially posted on February 1st 2015 and the last update was made July 27th 2022. Alternatives to this trial can be found in the form of 841 studies seeking out healthy volunteers, as well as 43 trials that actively recruiting for Active Delta-9-THC research."

Answered by AI

To what degree does Active Delta-9-THC pose a threat to individuals?

"As this is a Phase 1 assessment, there is restricted data confirming the safety and efficacy of delta-9-THC, hence our team at Power estimated its security level to be 1 on a scale from one to three."

Answered by AI

Is this experiment currently recruiting participants?

"This trial is now closed to new participants, as its last update was on July 27th 2022. Alternately, 841 clinical trials recruiting healthy volunteers and 43 experiments studying Active Delta-9-THC are currently open for enrolment."

Answered by AI

Does the research team require participants to be of legal age?

"According to the study's eligibility requirements, participants must be aged 18 at a minimum and 55 at a maximum."

Answered by AI

Are there any prior investigations associated with Active Delta-9-THC?

"Presently, there are 43 clinical trials actively researching the effects of Active Delta-9-THC with 6 in their third phase. Although Belmont, Massachusetts harbors several of these trials, they can also be found across 96 other sites."

Answered by AI

For what maladies has Active Delta-9-THC demonstrated efficacy?

"Active Delta-9-THC is a viable therapeutic option for those dealing with weight loss, inadequate response to conventional therapy, and pharmacotherapy."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
How old are they?
18 - 65
What site did they apply to?
Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
~4 spots leftby Mar 2025