Tetrahydrocannabinol (THC) and Sleep

Oregon Health & Science University (OHSU)

Status and phase: Completed; Early Phase 1

Conditions: Cannabis; THC; Sleep; Marijuana

Treatments: Drug: Dronabinol

Study type: Interventional

Funder types: Other

Identifiers

NCT03560934

IRB00018052

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 21 to 34 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Frequent Cannabis Users

Experimental group

Description:

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:

Drug: Dronabinol

Non Cannabis Users

Experimental group

Description:

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.

Treatment:

Drug: Dronabinol