Clinical trial NCT03560934: Tetrahydrocannabinol (THC) and Sleep
Official title: Effect of Tetrahydrocannabinol (THC) on Sleep in Humans
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Sleep
THC
Marijuana
Cannabis
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are initially categorized as non-frequent or frequent cannabis users based on their cannabis use behavior and then receive the same treatment of 10-60mg dronabinol upon participation in the study.
Primary purpose: BASIC_SCIENCE

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

Detailed description: 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.

Eligibility criteria: 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:
measure: Sleep Stages
timeFrame: Over the 3-night stay.
measure: Psychomotor Vigilance Change Across Four Day Inpatient Stay
timeFrame: Over the 3-night stay.
measure: Mean Change in Response Accuracy for Paced Auditory Serial Addition Test Across Four Day Inpatient Stay
timeFrame: Over the 3-night stay.
measure: Mean Change in Response Accuracy for Word Recall Across Four Day Inpatient Stay
timeFrame: Over the 3-night stay.
measure: Mean changes in Intoxication Levels on the Visual Analog Scale
timeFrame: Over the 3-night stay.
measure: Blood pressure
timeFrame: Over the 3-night stay.
measure: Heart Rate
timeFrame: Over the 3-night stay.
measure: Endothelial Function
timeFrame: Over the 3-night stay.
Secondary outcomes:
measure: Subjective measures of sleepiness/alertness
timeFrame: Over the 3-night stay.
measure: Caloric Intake
timeFrame: Over the 3-night stay.
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Steven A Shea, PhD
role: PRINCIPAL_INVESTIGATOR
References: