Oregon Health & Science University
Portland, Oregon, 97239, United States
NCT Number: NCT03560934
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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Notify Me21 year–34 year
All sexes
Interventional
Early Phase 1
Portland, Oregon, 97239, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single dose oral administration of 10-60mg dronabinol prior to night 2 or 3 sleep in the clinical laboratory.
Other names: Marinol
Time frame: Over the 3-night stay.
Polysomnographic recordings will be measured and scored across the three sleep periods for timing and sleep stages.
Time frame: Over the 3-night stay.
Psychomotor vigilance response times (in milliseconds) will be measured shortly after awakening each test morning.
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.
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.
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.
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.
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).
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.
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.
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.
Oregon Health and Science University
Other
Effect of Tetrahydrocannabinol (THC) on Sleep in Humans
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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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