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Completed

NCT Number: NCT03560934

Tetrahydrocannabinol (THC) and Sleep

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

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Key information

Age range

21 year–34 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dronabinol

Drug

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

Other names: Marinol

Primary outcomes

  1. Sleep Stages

    Time frame: Over the 3-night stay.

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

  2. Psychomotor Vigilance Change Across Four Day Inpatient Stay

    Time frame: Over the 3-night stay.

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

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

    Time frame: Over the 3-night 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.

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

    Time frame: Over the 3-night 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.

  5. Mean changes in Intoxication Levels on the Visual Analog Scale

    Time frame: Over the 3-night stay.

    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.

  6. Blood pressure

    Time frame: Over the 3-night stay.

    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.

  7. Heart Rate

    Time frame: Over the 3-night stay.

    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).

  8. Endothelial Function

    Time frame: Over the 3-night stay.

    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.

Secondary outcomes

  1. Subjective measures of sleepiness/alertness

    Time frame: Over the 3-night stay.

    Subjective sleepiness and alertness will be measured regularly (~1/h) across wake periods during the study protocol using the Stanford Sleepiness Scale. The scale measures subjective sleepiness on a 1-5 point Likert scale with 5 indicating the highest degree of sleepiness and 1 indicating the lowest degree of sleepiness.

  2. Caloric Intake

    Time frame: Over the 3-night stay.

    Participants will use a meal logging app to log all meals and beverages consumed for caloric/nutritional content and timing for a period prior to coming into the clinical laboratory.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Effect of Tetrahydrocannabinol (THC) on Sleep in Humans

Important dates

Study start
2018
Primary completion
2021
Study completion
2025
First posted
Jun 18, 2018
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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