Tetrahydrocannabinol (THC) and Sleep

NCT ID: NCT03560934

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2025-12-31

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.

Conditions

Sleep; THC; Marijuana; Cannabis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Frequent Cannabis Users

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.

Group Type: EXPERIMENTAL

Dronabinol

Intervention Type: DRUG

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

Non Cannabis Users

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 Type: EXPERIMENTAL

Dronabinol

Intervention Type: DRUG

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

Interventions

Dronabinol

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

Intervention Type: DRUG

Other Intervention Names

Marinol

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Nicole Bowles

Assistant Professor, Oregon Institute of Occupational Health Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven A Shea, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

IRB00018052

Identifier Type: -

Identifier Source: org_study_id