Clinical trial NCT06982950: Cannabis Association With Sleep Study
Official title: Longitudinal Reciprocal Relationships Between Cannabis Use, Sleep, and the HPA-axis (CaSS)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sleep
Keywords: Sleep, slow wave
Polysomnography
Marijuana Abuse
Cannabinoids
Ecological Momentary Assessment
Sleep Duration
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: After a baseline assessment of sleep, participants will undergo either 2 nights of restricted sleep (4h time in bed \[TIB\]) followed by a recovery sleep, OR 3 nights of an extended sleep opportunity (10h TIB)
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to learn more about cannabis use, sleep, and stress, and whether there is any relationship between the three.

Detailed description: After passing a physical assessment and psychological screen, 60 participants will be enrolled. Ahead of the 21-day protocol participants will report to our laboratory sleep facilities and will be set-up to perform a full polysomnography test (monitored overnight sleep with equipment including superficial electrodes, heart rate \[HR\] monitor, breathing monitors). This initial night of sleep with study equipment is provided in order to reduce sleep differences based on sleeping in a new environment and the burden of wearing equipment while sleeping. Before and after this 8h sleep period participants will be introduced to all surveys and behavioral testing that will be used as part of the experimental nights. Participants who complete the familiarization night will be randomized to two different possible experimental protocols that differ in the length of the sleep period. In order to fully characterize cannabis use behaviors (frequency, amount, mode of use) on sleep in an individual's typical environment (i.e. in the places and during the activities of normal living), we will implement 21 days of activity monitoring via multiple daily surveys (which collectively is a research strategy known as Ecological Monitoring Assessment \[i.e., EMA\]) along with concurrent actigraphy, that is, the monitoring of movement via the use of a wrist-worn watch-like device. Approximately one-week into this observational period, participants will complete the 2 x 4-night experimental nights (consecutive nights) with a washout (return to habitual sleep patterns) of at least 6 days.

Participants are able to spend the day outside of the laboratory during the experimental night period (i.e. they will come into the lab each night to sleep, and have their sleep monitored, but able to do normal activities during the days). Following in laboratory assessments, participants will complete any remaining at home assessments needed for 21 days of EMA/actigraphy.

Eligibility criteria: Inclusion Criteria:

* fluent in English
* 18.5\<BMI\<40 kg/m2
* no shift work in the last 12 months
* no travel across time zones in the last 2 months.

Exclusion Criteria:

* Chronic disease-Medical history/prior diagnosis of the following:
* cardiometabolic disease (e.g., myocardial infarction, angina, diabetes)
* essential hypertension
* hepatic impairment
* severe obstructive sleep apnea
* restless legs syndrome
* parasomnia
* neurological disease (e.g., early onset dementia)
* unstable psychiatric disorders (e.g., bipolar disorder, schizophrenia, major depression with suicidality).
* Drug/Alcohol use criteria:
* Illicit drugs apart from cannabis or related products are prohibitive.
* Volunteers may consume caffeine, however, \>3 cups of coffee (or otherwise equivalent of \>300mg/day) is prohibitive.
* Participants who consume \>14 alcoholic drinks/week and/or have a diagnosis (or history) of alcohol use disorder will be excluded (a toxicological urine screen will be conducted to verify reported non-use during the initial screening and on the day of admission to the in-laboratory portion of the study).
* Use of prescription or over-the-counter medications or supplements that affect sleep are also exclusionary.
* Contraceptives are required for women and will continue to be taken throughout the experiment.
* Prior Shift Work:
* Volunteers must have no history of working irregular day and night hours, regular night work, or rotating shift work for the 3 months prior to the study.

Primary outcomes:
measure: Daily Cannabis Use Frequency
timeFrame: Assessed in surveys performed 4 times per day, and across the entire 21-day study
measure: Wake After Sleep Onset (WASO)
timeFrame: 21 days
measure: Cortisol Awakening Response
timeFrame: 8 nights
Secondary outcomes:
measure: Wake After Sleep Onset (Polysomnography)
timeFrame: 8 nights
measure: Sleep Latency
timeFrame: 8 nights
measure: Total Sleep Time
timeFrame: up to 21 days
measure: Sleep Macroarchitecture
timeFrame: 8 nights
measure: Sleep Microarchitecture
timeFrame: 8 nights
measure: Median Reaction Time
timeFrame: 8 days
measure: Time to NREM1 Sleep (modified Maintenance of Wakefulness)
timeFrame: 8 days
measure: Subjective Sleepiness
timeFrame: 21 days
measure: Pre-Ejection Period
timeFrame: 8 days
measure: Sleep High Frequency Heart Rate Variability (HRV)
timeFrame: 8 nights
measure: Mood
timeFrame: 21 days
measure: Cannabis Use Composite Score
timeFrame: 21 days
measure: Positive Affect
timeFrame: 21 days
measure: Negative Affect
timeFrame: 21 days
measure: Sleep Low Frequency HRV
timeFrame: 8 nights
measure: Sleep Normalized HF Power
timeFrame: 8 nights
measure: Sleep standard deviation of the R-R interval of normal sinus beats (SDNN)
timeFrame: 8 nights
measure: Area under the curve of the CAR
timeFrame: 8 nights
Other outcomes:
Locations:
Study officials:
References: