18 Participants Needed

THC (Dronabinol) for Sleep Issues in Cannabis Users

NB
AS
Overseen ByAlicia Stewart, BS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 5 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

SA

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
See 15 more

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?
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.

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

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Approved in United States as Marinol for:
  • HIV/AIDS-induced anorexia
  • Chemotherapy-induced nausea and vomiting
  • Sleep apnea
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Approved in United States as Syndros for:
  • HIV/AIDS-induced anorexia
  • Chemotherapy-induced nausea and vomiting
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Approved in Canada as REDUVO for:
  • HIV/AIDS-induced anorexia
  • Chemotherapy-induced nausea and vomiting

Find a Clinic Near You

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials
1,024
Recruited
7,420,000+
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