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Cannabinoid

THC (Dronabinol) for Sleep Issues in Cannabis Users

Phase < 1
Waitlist Available
Led By Steven A Shea, PhD
Research Sponsored by Oregon Health and Science 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 over the 3-night stay.
Awards & highlights

Study Summary

This trial will study the effects of oral THC on sleep in people who don't often and those who often use cannabis.

Who is the study for?
This trial is for adults who have used cannabis less than 10 times ever or those using it more than three times a week for the last three months. It's not suitable for individuals with cardiovascular disease, seizure history, certain psychiatric conditions, severe liver issues, drug dependencies (excluding THC), or those on medications including antidepressants.Check my eligibility
What is being tested?
The study is examining how different doses of dronabinol (oral THC) ranging from 10-60mg affect sleep patterns in people who use cannabis infrequently and those who use it frequently.See study design
What are the potential side effects?
Potential side effects of dronabinol may include dizziness, dry mouth, altered mental state, mood changes, heart rate increase and gastrointestinal symptoms like nausea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over the 3-night stay.
This trial's timeline: 3 weeks for screening, Varies for treatment, and over the 3-night stay. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood pressure
Endothelial Function
Heart Rate
+5 more
Secondary outcome measures
Caloric Intake
Subjective measures of sleepiness/alertness

Trial Design

2Treatment groups
Experimental Treatment
Group I: Non Cannabis UsersExperimental Treatment1 Intervention
Non-cannabis users (who have not used cannabis more than 10 times in their lifetime) will undergo the same single dose dronabinol and placebo as the frequent cannabis user arm, under the identical study procedure.
Group II: Frequent Cannabis UsersExperimental Treatment1 Intervention
Subjects categorized as frequent cannabis users (>3x/week for 3 months) will receive a single dose of 10-60mg dronabinol on the second or third night of their stay in the clinical laboratory, one hour prior to bedtime and five minutes after completion of a study snack. The other night, participants will receive a placebo. Dronabinol is an orally active, synthetic THC currently indicated for weight loss in patients with acquired immune deficiency syndrome (AIDS) or anorexia and for nausea and vomiting associated with cancer. Dronabinol is nearly absorbed (90%-95%) after a single oral dose of the capsule formulation with 10-20% of the administered dose researching the systemic circulation due to extensive first-pass hepatic metabolism and high lipid solubility. The onset of action is ~30 to 60 minutes with peak effects from 2-4-h following dose (Fig. 2) (34). The 10-60mg of dronabinol will be administered by OHSU's research pharmacy services.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dronabinol
2003
Completed Phase 4
~2080

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
966 Previous Clinical Trials
6,845,733 Total Patients Enrolled
7 Trials studying Sleep
1,653 Patients Enrolled for Sleep
Steven A Shea, PhDPrincipal InvestigatorOregon Health and Science University
3 Previous Clinical Trials
107 Total Patients Enrolled

Media Library

Dronabinol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT03560934 — Phase < 1
Sleep Research Study Groups: Non Cannabis Users, Frequent Cannabis Users
Sleep Clinical Trial 2023: Dronabinol Highlights & Side Effects. Trial Name: NCT03560934 — Phase < 1
Dronabinol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03560934 — Phase < 1
Sleep Patient Testimony for trial: Trial Name: NCT03560934 — Phase < 1

Frequently Asked Questions

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

For which ailments is Dronabinol typically prescribed?

"Dronabinol is frequently used as a means of ameliorating weight loss and can also be deployed to address inadequate response to conventional treatment regimens, pharmacotherapy, and anorexia."

Answered by AI

Are there any unfilled slots available for this research endeavor?

"This research is no longer accepting applications. It was posted on September 1st 2018 and last updated May 27th 2022. For those in search of other studies, 271 trials are currently onboarding participants for cannabis-based treatments while 38 clinical trials are taking partakers with Dronabinol."

Answered by AI

What is the enrollment capacity of this medical research study?

"At this moment, enrollment for this particular trial is closed. It was initially announced on September 1st of 2018 and edited most recently on May 27th 2022. For individuals looking to participate in other research studies, there are presently 271 trials that involve marijuana and 38 more for dronabinol actively recruiting volunteers."

Answered by AI

Are there any other experiments that have been conducted to explore the potential of Dronabinol?

"Presently, there are 38 separate studies for Dronabinol with 6 of them at the advanced Phase 3 level. Belmont, Massachusetts is home to many of those trials, but a total of 90 medical centres across the United States are running such research."

Answered by AI

Is the age limit for volunteers of this research project greater than forty years?

"This trial only admits those between 21 to 34 years of age. For younger and older patients, there are 47 and 162 trials respectively available for them."

Answered by AI

Who qualifies to partake in this medical study?

"Qualified individuals for this study must have a history of marijuana use and be between 21-34 years old. Currently, the team is recruiting around 18 participants."

Answered by AI

Who else is applying?

What state do they live in?
Washington
Idaho
How old are they?
18 - 65
What site did they apply to?
Oregon Health & Science University
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I’ve tried so many things, nothing has worked. I'm in treatment for DCIS just starting radiation and am seeking options for pain relief. I'm also seeking options for side effects of aromatase inhibitors that are to be prescribed in the future. This is a second breast cancer for me and I quit taking Tamoxifen after 1 year due to side effects.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Can screening be done remotely? How long do they take? What are the qualifications of the trial? What are the exclusions of the trial?
PatientReceived no prior treatments
~3 spots leftby Mar 2025