INTERVENTIONALCOMPLETEDNCT03560934

Effect of Tetrahydrocannabinol (THC) on Sleep in Humans

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

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-02-05

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: EARLY PHASE1
Enrollment: 18 (ACTUAL)
Start date: 2018-09-01
Sponsor: Oregon Health and Science University
Design: NON RANDOMIZED · PARALLEL · BASIC SCIENCE
Locations: 1
Results record: Not present in registry snapshot

The investigators plan to test the effects of 10-60 mg dronabinol (oral THC) on subjective (surveys) and objective (polysomnographically scored (PSG)) sleep in non-frequent and frequent cannabis users following an acclimation and baseline night of sleep. The mornings after baseline sleep and dronabinol administration, cognitive performance will also be measured and participants may also perform morning typical behaviors such as change in posture (getting out of bed/tilt test) and mild intensity physical activity. This pilot study is in healthy young adults without a history of chronic disease.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

Delta(9)-tetrahydrocannabinol

Medicines

DRONABINOL DRONABINOL DRONABINOL DRONABINOL MARINOL Marinol MARINOL

Interventions

What was registered

DRUG

Dronabinol

Single dose oral administration of 10-60mg dronabinol prior to night 2 or 3 sleep in the clinical laboratory.

Marinol

Eligibility

Population and criteria

Sex: ALL
Minimum age: 21 Years
Maximum age: 34 Years
Healthy volunteers: Accepted

Inclusion criteria

Frequent Cannabis Use (\>3x/week for the prior 3 months) or
No Cannabis Use (Less than 10x ever)

Exclusion criteria

Sleep Apnea
Pregnancy
Diabetes
Cardiovascular disease
Chronic Pain
History of seizures
Severe Hepatic impairment
Conditions associated with clinically relevant cognitive impairment
Symptoms of acute or active illness (e.g., fever and leukocytosis)
Evidence of psychopathology on the Beck Depression Index II (BDI-II or in a structured clinical interview with a physician
History of severe psychiatric illnesses (including such as alcoholism, drug dependency including a cannabis use disorder score ≥12 on the Cannabis Use Disorders Identification Test (CUDIT) (28) or \>1 withdrawal symptom on the Marijuana Withdrawal Checklist (MWC (29)) , major depression, manic depressive illness, schizophrenic disorders, panic disorder, generalized anxiety disorder, post-traumatic stress disorder, agoraphobia, claustrophobia, paranoid personality disorder, schizoid personality disorder, schizotypal personality disorder, borderline personality disorder, and antisocial personality disorder.)
History of having been treated with antidepressants, neuroleptic medications, or tranquilizers.
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.
Current Nicotine use ( or history of more than 5 'pack years' of smoking)
Current use of prescription or over the counter medications
History of shift work in the last 6 months
Travel across \>2 time zones during the month prior to the study
Habitual bedtime after 1am or waketime before 5am

primary outcomes