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

18 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators will test the effects of 10-60mg dronabinol (oral THC) on sleep in non-frequent and frequent cannabis users.

Research Team

Steven A Shea, PhD

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+