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Cannabinoid

Inhaled THC for Cannabis Response Differences by Gender (THC-Gender-II Trial)

Phase 1
Recruiting
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Good physical and mental health
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and +80 minutes after start of oral dronabinol administration.
Awards & highlights

THC-Gender-II Trial Summary

This trial looks at how cannabinoids affect men and women differently, and tries to figure out why those differences exist.

Who is the study for?
This trial is for healthy men and women who have tried cannabis at least once. It's not suitable for those who've never used cannabis or are currently dealing with major stress.Check my eligibility
What is being tested?
The study is looking into how inhaled THC (the active ingredient in cannabis) affects men and women differently by comparing it to a placebo, which has no active ingredients.See study design
What are the potential side effects?
While the side effects aren't listed, typical reactions to THC may include altered senses, mood changes, difficulty with thinking and problem-solving, impaired memory, and occasionally anxiety.

THC-Gender-II Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am in good physical and mental health.

THC-Gender-II Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and +80 minutes after start of oral dronabinol administration.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and +80 minutes after start of oral dronabinol 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 from Baseline: Rewarding Effects measured by Visual Analog Scale (VAS)
Change from Baseline: Verbal Learning: Measured by Rey Auditory Verbal Learning Test (RAVLT)

THC-Gender-II Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Delta-9-Tetrahydrocannabinol (THC)Active Control1 Intervention
4 mg vaporized THC will be administered.
Group II: PlaceboPlacebo Group1 Intervention
Inhaled placebo (no active cannabinoids)

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
1,843 Previous Clinical Trials
2,735,137 Total Patients Enrolled
14 Trials studying Cannabis
724 Patients Enrolled for Cannabis

Media Library

Inhaled THC (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT04704271 — Phase 1
Cannabis Research Study Groups: Delta-9-Tetrahydrocannabinol (THC), Placebo
Cannabis Clinical Trial 2023: Inhaled THC Highlights & Side Effects. Trial Name: NCT04704271 — Phase 1
Inhaled THC (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04704271 — Phase 1

Frequently Asked Questions

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

Has the FDA validated Delta-9-Tetrahydrocannabinol (THC) for medicinal use?

"Our team at Power assessed the safety of Delta-9-Tetrahydrocannabinol (THC) to be a 1, as this is a Phase 1 trial with limited evidence in support of its efficacy and security."

Answered by AI

Have past experiments utilized Delta-9-Tetrahydrocannabinol (THC) for their research purposes?

"Currently, 6 Phase 3 studies and 38 other active trials exist for Delta-9-Tetrahydrocannabinol (THC). Out of the 90 locations running clinical trials on this substance, a majority are based in Belmont, Massachusetts."

Answered by AI

How many participants are currently enrolled in this research program?

"Affirmative. Data on clinicaltrials.gov reveals that the recruitment period for this medical trial is still ongoing, having been first posted in October 2019 and last edited in July 2022. This experiment requires 100 individuals to be recruited from a single site."

Answered by AI

Are there currently opportunities to participate in the research trial?

"Yes, the data found on clinicaltrials.gov shows that this medical investigation is presently looking for volunteers. This research effort was launched on October 9th 2019 and last modified July 21st 2022; it seeks 100 participants at a single site."

Answered by AI

Are persons below the age of 70 able to join this research experiment?

"This medical research is enrolling individuals that are above the age of consent and not beyond 55 years old."

Answered by AI

In what ways is Delta-9-Tetrahydrocannabinol (THC) typically employed therapeutically?

"Delta-9-Tetrahydrocannabinol (THC) is an effective therapeutic for obesity, unresponsiveness to conventional treatments, and pharmacotherapy."

Answered by AI

For whom is this clinical investigation available?

"A hundred patients between 18 and 55 that have had prior exposure to cannabis are eligible for this clinical trial. Recruits must be in good physical and psychological health."

Answered by AI

Who else is applying?

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 Jun 2024