Tetrahydrocannabinol (THC) and Sleep

NCT03560934 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: IRB00018052
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cannabis; Sleep; THC; Marijuana

Outcome Measures

Primary Outcomes (8)

• Sleep Stages

  Polysomnographic recordings will be measured and scored across the three sleep periods for timing and sleep stages.

  Over the 3-night stay.

• Psychomotor Vigilance Change Across Four Day Inpatient Stay

  Psychomotor vigilance response times (in milliseconds) will be measured shortly after awakening each test morning.

  Over the 3-night stay.

• Mean Change in Response Accuracy for Paced Auditory Serial Addition Test Across Four Day Inpatient Stay

  Processing speed and working memory (response accuracy) will be measured shortly after awakening each test morning. Scores can range from a minimum of 0 to 60 correct responses with each test.

  Over the 3-night stay.

• Mean Change in Response Accuracy for Word Recall Across Four Day Inpatient Stay

  Verbal memory will be measured shortly after awakening each test morning. Scores can range from recalling 0 words to the complete list. Participants are blinded as to list length.

  Over the 3-night stay.

• Mean changes in Intoxication Levels on the Visual Analog Scale

  Assessed by visual analog scale (Minimum=0, Maximum=100). 0 is "Not at all" and 100 is "Extremely". Questions ask about feeling drug effect, high right now, and wanting more of the study drug.

  Over the 3-night stay.

• Blood pressure

  Blood pressure (BP) will be measured every 30 min during wake and every 15 minutes during sleep. Beat-by-beat (BP) will be measured during sleep using a non-invasive device employing the volume-clamp method with hydrostatic correction (BMeye Nexfin or AD Instruments NIBP). Additionally an automated calibrated sphygmomanometer will be used to record sporadic BP at intervals during an exercise challenge.

  Over the 3-night stay.

• Heart Rate

  For the duration of the study, 2 channels of EKG are recorded (RA-V6) and stored at a sample frequency of 256 Hz. This software will be used for peak detection (R-wave detection and subsequent heart rate variability (HRV) analysis to estimate cardiac vagal tone).

  Over the 3-night stay.

• Endothelial Function

  Endothelial Function will be measured as Flow Mediated Dilation in the brachial artery 10 minutes after each awakening and 20 minutes before each sleep period.

  Over the 3-night stay.

Secondary Outcomes (2)

• Subjective measures of sleepiness/alertness

  Over the 3-night stay.

• Caloric Intake

  Over the 3-night stay.

Study Arms (2)

Frequent Cannabis Users

EXPERIMENTAL

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.

Drug: Dronabinol

Non Cannabis Users

EXPERIMENTAL

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.

Drug: Dronabinol

Interventions

Dronabinol DRUG

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

Also known as: Marinol

Frequent Cannabis Users; Non Cannabis Users

Eligibility Criteria

• Age: 21 Years - 34 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Steven A Shea, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Oregon Institute of Occupational Health Sciences

Model Details: 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.

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: June 18, 2018
• Study Start: September 1, 2018
• Primary Completion: September 19, 2021
• Study Completion: December 31, 2025
• Last Updated: February 5, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)