THC (Dronabinol) for Sleep Issues in Cannabis Users

Overseen By Alicia Stewart, BS

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Oregon Health and Science University

Must not be taking: Antidepressants, Neuroleptics, Tranquilizers, others

Disqualifiers: Diabetes, Cardiovascular disease, Chronic pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 3 nights

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test how dronabinol, a synthetic form of THC, affects sleep in both frequent and rare cannabis users. Researchers seek to determine if dronabinol can improve sleep patterns. Participants will include frequent cannabis users (those using cannabis more than three times a week for the past three months) and non-users (those who have used cannabis less than ten times ever). This study may suit individuals who have used cannabis frequently or very rarely and are interested in how dronabinol might aid sleep. As an Early Phase 1 trial, this research focuses on understanding dronabinol's effects in people, offering participants a chance to be among the first to explore its impact on sleep.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any current prescription or over-the-counter medications to participate in this trial.

Is there any evidence suggesting that dronabinol is likely to be safe for humans?

Research has shown that dronabinol, a synthetic version of THC (the main active component of cannabis), is generally safe for certain health conditions. It is already approved to aid weight loss in AIDS patients and alleviate nausea in cancer patients, indicating safety when used as directed.

However, the effects of dronabinol and cannabis on sleep can vary. Some studies have found that cannabis may improve sleep for some individuals, while others have found it can disrupt sleep. Specifically, heavy or prolonged use might reduce deep sleep or REM sleep, which are crucial for feeling well-rested.

This trial is in an early stage and primarily aims to assess how the body processes different doses of dronabinol. In other contexts, it appears safe for short-term use, but its impact on sleep can differ among individuals. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional sleep aids that often rely on sedative effects, dronabinol is unique because it utilizes synthetic THC, a compound commonly associated with cannabis. This offers a new mechanism of action by potentially regulating sleep through the endocannabinoid system, which is not targeted by standard sleep medications like benzodiazepines or antihistamines. Researchers are excited about dronabinol because it could provide an alternative for individuals who use cannabis and struggle with sleep, offering benefits that align more closely with the natural compounds they're already familiar with. Additionally, its oral delivery method and absorption profile may offer a more predictable onset and duration of sleep improvement.

What evidence suggests that dronabinol might be an effective treatment for sleep issues in cannabis users?

This trial will evaluate the effects of dronabinol, a pill form of THC, on sleep issues in both frequent and non-cannabis users. Research has shown that dronabinol may help with sleep problems by improving breathing issues during sleep, known as the Apnea-Hypopnea Index (AHI). Some evidence also suggests it can reduce daytime sleepiness. However, high doses of THC can lead to poor sleep. While some people use cannabis to aid sleep, many still struggle to fall or stay asleep. Overall, dronabinol appears promising for improving sleep, but further research is needed. ^{1 2 6 7 8}

Who Is on the Research Team?

Steven A Shea, PhD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Frequent Cannabis Use (>3x/week for the prior 3 months)

No Cannabis Use (Less than 10x ever)

Exclusion Criteria

I have been treated with antidepressants, neuroleptics, or tranquilizers.

I do not use drugs, alcohol, caffeine, or nicotine and can avoid them during the study.

History of shift work in the last 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Acclimation and Baseline

Participants undergo an acclimation and baseline night of sleep to establish baseline sleep patterns

1 night

1 visit (in-person)

Treatment

Participants receive a single dose of 10-60mg dronabinol or placebo, with sleep and cognitive performance measured

3 nights

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dronabinol

Trial Overview

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.

How Is the Trial Designed?

Group I: Non Cannabis Users Experimental Treatment 1 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 Users Experimental Treatment 1 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.

Dronabinol is already approved in United States, Canada for the following indications:

Approved in United States as Marinol for:

• HIV/AIDS-induced anorexia
• Chemotherapy-induced nausea and vomiting
• Sleep apnea

Approved in United States as Syndros for:

• HIV/AIDS-induced anorexia
• Chemotherapy-induced nausea and vomiting

Approved in Canada as REDUVO for:

• HIV/AIDS-induced anorexia
• Chemotherapy-induced nausea and vomiting

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8116407/

Effects of Cannabinoids on Sleep and their Therapeutic ...

In human studies, dronabinol has been shown to decrease Apnea-Hypopnea Index (AHI) and subjective sleepiness in a phase II placebo-controlled ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7572650/

Cannabis Use and Sleep: Expectations, Outcomes, and the ...

Though acute use might be associated with sleep enhancements, low dose CBD and high dose THC is associated with negative sleep outcomes and consecutive days of ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S1087079225001170

Cannabis and sleep architecture: A systematic review ...

However, withdrawal from active cannabis use was consistently associated with sleep disturbances, including reduced total sleeping times and ...

4.

cannabisevidence.org

cannabisevidence.org/clinician-resources/clinician-briefs/cannabis-and-sleep/

Cannabis and Sleep

More than half of individuals who reported using cannabis for sleep problems continued to report difficulties falling asleep (53%) or staying asleep (54%) at ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03560934

NCT03560934 | Tetrahydrocannabinol (THC) and Sleep

The investigators plan to test the effects of 10-60 mg dronabinol (oral THC) on subjective (surveys) and objective (polysomnographically scored (PSG)) sleep ...

6.

link.springer.com

link.springer.com/article/10.1007/s12094-025-04069-8

The effects of tetrahydrocannabinol and cannabidiol on ...

Promisingly, a randomized trial of adults experiencing sleep disturbance found that chronic use of a low dose of CBD was safe and may improve ...

7.

sleepfoundation.org

sleepfoundation.org/sleep-aids/cannabis-and-sleep

Cannabis for Sleep: Benefits and Risks

Risks of Long-Term Use: Prolonged or heavy cannabis use may impair sleep quality, leading to less overall sleep, disruption of deep or REM sleep ...

8.

jcsm.aasm.org

jcsm.aasm.org/doi/10.5664/jcsm.10428

Cannabis and sleep disorders: not ready for prime time? A ...

The utilization of cannabis showed improved sleep (21%), worse sleep (48%), mixed results (14%), or no impact at all (17%) in the studies published in the last ...