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Cannabinoid

Dronabinol Effects Related to Cannabis Use (THC-Gender-I 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
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-I Trial Summary

This trial will help researchers understand how cannabinoids affect men and women differently and what underlying mechanisms may cause these differences.

Who is the study for?
This trial is for healthy men and women who have tried cannabis at least once. Women must not be taking estrogen supplements or oral contraceptives, and participants with a sesame oil allergy cannot join. Those under major stress recently or currently are also excluded.Check my eligibility
What is being tested?
The study aims to understand how cannabinoids affect men and women differently by comparing the effects of Dronabinol (a synthetic form of THC) to a placebo in healthy individuals.See study design
What are the potential side effects?
Dronabinol can cause dizziness, dry mouth, feeling 'high', sleepiness, nausea, and sometimes confusion or hallucinations. The placebo should not cause any side effects unless there's an unexpected reaction.

THC-Gender-I 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-I Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: THCActive Control1 Intervention
10 mg Dronabinol will be administered orally.
Group II: PlaceboPlacebo Group1 Intervention
Placebo pill (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
1,847 Previous Clinical Trials
2,737,628 Total Patients Enrolled
14 Trials studying Cannabis
784 Patients Enrolled for Cannabis

Media Library

Dronabinol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT02811510 — Phase 1
Cannabis Research Study Groups: THC, Placebo
Cannabis Clinical Trial 2023: Dronabinol Highlights & Side Effects. Trial Name: NCT02811510 — Phase 1
Dronabinol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02811510 — Phase 1

Frequently Asked Questions

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

Does THC have a history of being used in other scientific investigations?

"At the moment, there are 44 studies underway that involve THC. 7 of those studies are in Phase 3. Although most of the studies for THC are based in Belmont, Massachusetts, there are 113 locations running trials for this treatment."

Answered by AI

If I wanted to participate in this research, what would the process entail?

"To be included in this study, which is testing the effects of a new medication for hashish abuse, patients must be between 18 and 55 years old. In addition, all participants must have had at least one exposure to cannabis in their lifetime and be in good physical and mental health."

Answered by AI

Are patients being accepted into this research program at this time?

"Active recruitment for this clinical trial is underway, as indicated by the listing on clinicaltrials.gov. This particular study was originally posted on June 1st, 2016 with the most recent update taking place on July 26th, 2022."

Answered by AI

Can THC be used medicinally without causing harm?

"THC received a score of 1 because, at this stage in the clinical trial process, there is only limited data to support its safety and efficacy."

Answered by AI

How does THC help patients who suffer from various conditions?

"Symptoms such as weight loss, lack of response to common treatments, and adverse effects from medications can be helped by THC."

Answered by AI

For this particular clinical trial, is the age limit 25 years or older?

"For this particular study, volunteers aged 18 to 55 are eligible. In contrast, there are 16 clinical trials that accept participants who are below 18 and 75 studies recruiting people over the age of 65."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study I
Mohini Ranganathan 2016. "Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study I". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02811510.
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~0 spots leftby Jun 2024
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