Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06982950

Cannabis Association With Sleep Study

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

21 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Manipulation of Sleep Duration

Other

After a baseline assessment of sleep, participants will undergo either 2 nights of restricted sleep (4 hour time in bed) followed by a recovery sleep, OR 3 nights of an extended sleep opportunity (10 hour time in bed)

Primary outcomes

  1. Daily Cannabis Use Frequency

    Time frame: Assessed in surveys performed 4 times per day, and across the entire 21-day study

    The number of smoking/vaping sessions per day.

  2. Wake After Sleep Onset (WASO)

    Time frame: 21 days

    Wake after sleep onset (measured in minutes) will be assessed each night from actigraphy; larger value indicates greater disruptions to sleep.

  3. Cortisol Awakening Response

    Time frame: 8 nights

    Salivary cortisol levels assessed as the difference between waking and peak levels assessed ~30-45 minutes after awakening.

Secondary outcomes

  1. Wake After Sleep Onset (Polysomnography)

    Time frame: 8 nights

    Wake after sleep onset (measured in minutes) will be assessed each night of the in laboratory study using polysomnography [PSG]); larger value indicates greater disruptions to sleep.

  2. Sleep Latency

    Time frame: 8 nights

    Measured in minutes and assessed each night of the in laboratory study using polysomnography; assessed at time from in bed and lights off to any stage of sleep including Non rapid eye movement (NREM) 1.

  3. Total Sleep Time

    Time frame: up to 21 days

    Measured (in minutes)from actigraphy (21 days of data) and in laboratory study using polysomnography (8 nights of data).

  4. Sleep Macroarchitecture

    Time frame: 8 nights

    Non rapid eye movement (NREM) 1-3 and Rapid eye movement (REM), time and %, assessed each night of the in laboratory study using polysomnography.

  5. Sleep Microarchitecture

    Time frame: 8 nights

    Delta power, theta power, and alpha power during quiet wakefulness and sleep assessed during the in laboratory study using polysomnography.

  6. Median Reaction Time

    Time frame: 8 days

    Assessed from a 10 minute psychomotor vigilance test approximately hourly during the in laboratory component of the study; larger value indicates reduced vigilance.

  7. Time to NREM1 Sleep (modified Maintenance of Wakefulness)

    Time frame: 8 days

    Assessment of sleep pressure using a modified Maintenance of Wakefulness test provided approximately hourly during the in laboratory component of the study.

  8. Subjective Sleepiness

    Time frame: 21 days

    Assessed 4-5 times/day as part of the Ecological Monitoring Assessment (EMA) and approximately hourly during the in laboratory component of the study using the Karolinska Sleepiness Scale (KSS). The KSS uses a 9-point scale with 1 = extremely alert and 9 = extremely sleepy - fighting sleep.

  9. Pre-Ejection Period

    Time frame: 8 days

    Using continuous electrocardiogram (EKG) during the in laboratory portion of the study we will calculate the interval between the Q wave on the EKG signal and the B point on the dZ/dt signal.

  10. Sleep High Frequency Heart Rate Variability (HRV)

    Time frame: 8 nights

    Assessed from continuous EKG during the in laboratory portion of the study, high frequency (HF; 0.15-0.4 Hz) HRV will be calculated by passing R-R intervals through a fast Fourier power spectral analysis on all 2-minute periods of nocturnal EKG of stable PSG identified sleep.

  11. Mood

    Time frame: 21 days

    Daily assessments of mood will be collected during the EMA using abbreviated versions of Profile of Mood States (POMS) with each mood description rated on a 5-point scale between not at all (0) to extremely (4).

  12. Cannabis Use Composite Score

    Time frame: 21 days

    Composite score based on daily frequency of use, amount of use, time of use, and method of use.

  13. Positive Affect

    Time frame: 21 days

    Daily assessments of positive affect will be collected during the EMA using The Positive and Negative Affect Schedule (PANAS) scales with values ranging from 10-50 (high score representing higher levels of positive affect).

  14. Negative Affect

    Time frame: 21 days

    Daily assessments of negative affect will be collected during the EMA using the PANAS with values ranging from 10-50 (lower scores representing lower levels of negative affect).

  15. Sleep Low Frequency HRV

    Time frame: 8 nights

    Assessed from continuous EKG during the in laboratory portion of the study, low frequency (LF; 0.04-0.15 Hz) HRV will be calculated by passing R-R intervals through a fast Fourier power spectral analysis on all 2-minute periods of nocturnal EKG of stable PSG identified sleep.

  16. Sleep Normalized HF Power

    Time frame: 8 nights

    Normalized HF power is calculated by dividing integrated HF spectra by the total power (LF+HF) and multiplying by 100.

  17. Sleep standard deviation of the R-R interval of normal sinus beats (SDNN)

    Time frame: 8 nights

    Time domain HRV will be expressed using the standard deviation of the R-R interval of normal sinus beats (SDNN) during stable 2-minute segments of sleep.

  18. Area under the curve of the CAR

    Time frame: 8 nights

    Total amount of cortisol secreted after awakening assessed using the trapezoidal rule to assess area under the curve from waking to 60 minutes post waking saliva cortisol levels.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicole Bowles, PhD

CONTACT

[email protected]

5034942541

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Longitudinal Reciprocal Relationships Between Cannabis Use, Sleep, and the HPA-axis (CaSS)

Acronym: CaSS

Important dates

Study start
2025
Primary completion
2030
Study completion
2032
First posted
May 21, 2025
Registry last updated
May 21, 2025

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.

Published trials that share one or more normalized conditions with this study.