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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

Must not have

Volunteers must be drug-free (including caffeine, nicotine, alcohol and herbal medications) for the duration of the screening and study period (with the exception of THC), with no dependence on drugs (e.g. cocaine, opioids, amphetamine, methamphetamine, PCP, benzodiazepines, barbiturates, methadone, MDMA); or alcohol dependency

Symptoms of acute or active illness (e.g., fever and leukocytosis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over the 3-night stay.

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I do not have symptoms like fever or a high white blood cell count.

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I have a history of seizures.

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I have severe liver problems.

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I have been diagnosed with sleep apnea.

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I have a heart condition.

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I have not traveled across more than 2 time zones in the last month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over the 3-night stay.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blood pressure

Endothelial Function

Heart Rate

+5 more

Secondary study objectives

Caloric Intake

Subjective measures of sleepiness/alertness

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 7Eligibility criteria met