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Cannabis UseCASCILSNCT06743373

Cannabis Effects on Sleep, Circadian Rhythms, and Light Sensitivity in Young Adults

A study testing Cannabis Discontinuation in people with Cannabis Use and Sleep, run by University of Pittsburgh at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this study is to learn how cannabis use and discontinuation affect sleep, circadian rhythms, and sensitivity to light. The main questions it aims to answer are: 1. Does cannabis use and discontinuation impact sleep drive? 2. Does cannabis use and discontinuation impact light sensitivity and circadian phase? Read more about this study

Who is it for?
Ages 18 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Cannabis Use, Sleep, Circadian Rhythm
What is being tested?
Cannabis Discontinuation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteUnited States
Study dates
13 Mar 2025to 30 Apr 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

List the inclusion criteria:

  • Age 18-25 years
  • Physically and psychiatrically healthy, as determined by instruments described below
  • Cannabis-Using group only: Regular cannabis use, defined as "frequent" (6-29 days/month) or "daily" (daily) use over the past 3 months
  • Cannabis-Using group only: Willingness to discontinue cannabis for 4 weeks.
  • Control group only: No cannabis use in the past 3 months. Deny engaging in daily or near-daily cannabis use during the past year. No history of alcohol and/or substance use disorders. No current sleep disorders (including insomnia and delayed sleep phase disorder).
  • Provision of written informed consent

List the exclusion criteria:

  • Significant or unstable acute or chronic medical conditions. Examples of such conditions include, but are not limited to, central nervous system disorders (e.g., head injury, seizure disorder, multiple sclerosis, tumor), cardiovascular or hemodynamically significant cardiac disease, liver disease (e.g., acute or chronic hepatitis, hepatic insufficiency), migraine or chronic headaches, active peptic ulcer disease, inflammatory bowel disease, renal failure, arthritis, and diabetes and other endocrine disorders. Seizure disorder in particular will be exclusionary due to the increased risk it confers for cannabis withdrawal symptoms. Eye/retinal conditions such as diabetic retinopathy or glaucoma will be exclusionary, although should be very rare in this population. Individuals with well-controlled health conditions that do not affect sleep, retinal function, and/or well-being (e.g., well-controlled thyroid disorders, asthma, or ulcer) will not be excluded. To evaluate these criteria, potential participants will complete a locally-developed Medical History Questionnaire.
  • Past or current DSM-5 bipolar disorder or psychotic disorders. Psychiatric disorders will be evaluated using the Mini International Neuropsychiatric Interview (MINI) and the WHO-DAS 2.0, supplemented by clinical interview. We will not exclude participants for subsyndromal symptoms or disorders in these domains. We will not exclude participants for other psychiatric disorders, particularly given the high comorbidity between cannabis use disorder and major depression and anxiety disorder, as long as severity is in the moderate range or lower based on the WHO-DAS 2.0 (average score <4).
  • Daily use of alcohol; regular use of illicit substances. Regular use (as defined above) of illicit substances other than cannabis over the past 3 months will be exclusionary. Substance use will be assessed using the Timeline Follow Back method, as well as a urine drug screen.
  • Past or current substance use disorders other than cannabis use disorder, nicotine use disorder, and mild alcohol use disorder (moderate and severe alcohol use disorder are exclusionary).
  • Current syndromal sleep disorders other than insomnia and delayed sleep phase disorder, including narcolepsy, restless legs syndrome, obstructive sleep apnea, and current night shift work (i.e., any work occurring between the hours of midnight and 6:00 a.m.). We will not exclude for subsyndromal symptoms or disorders in these domains. We will not exclude Cannabis-using participants for insomnia and delayed sleep phase disorder because of their conceptual overlap and high co-occurrence with sleep phenotypes of interest. Sleep disorders will be diagnosed according to criteria in the DSM-5 and the International Classification of Sleep Disorders, 3rd Edition, 2014. These disorders will be evaluated using clinical interview and the locally-developed Structured Clinical Interview for Sleep Disorders. Control participants will be excluded for any current sleep disorders, including insomnia and delayed sleep phase disorder.
  • Travel across 2+ time zones in the past 60 days.
  • Benzodiazepines and non-benzodiazepine hypnotic drugs ("Z-drugs"). Other sleep-promoting medications will be permitted, including SSRIs/SNRIs, will be permitted if on stable dose and not in the acute phase of treatment. In order to evaluate medications, participants will complete a listing of current medications, including prescription and over the counter medications, "natural" preparations, and nutritional supplements.
  • Individuals with a Pennsylvania Medical Marijuana Card using dispensary-obtained marijuana or other THC products for documented Qualifying Medical Conditions other than those of a mental health nature will be excluded. However, individuals who have been issued a Pennsylvania Medical Marijuana ID card for a mental health condition will not be excluded from the study.

There will not be any Medical Record review. For most individuals, the Medical History Questionnaire, including medical conditions and medications, will be sufficient for identifying exclusionary medical criteria. For instances where an individual is uncertain about exclusionary or current medical conditions or medications, medical records, prescription records or labeled prescription pill bottles, or a Release of Information to contact the individual's Primary Care Practitioner [PCP] to clarify the individual's medical status will be obtained.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brant P Hasler, PhD contact

412-246-6413

haslerbp@upmc.edu

United States1 site, 1 recruiting
  • Western Psychiatric Hospital (Thomas Detre Hall)

    Pittsburgh, Pennsylvania, 15213

    Brant P Hasler, PhD, 412-246-6413, haslerbp@upmc.edu

    Recruiting

Other trials in United States

About this study

Official title: Cannabis Effects on Sleep, Circadian Rhythms, and Light Sensitivity in Young Adults (CASCILS)

The goal of this study is to learn how cannabis use and discontinuation affect sleep, circadian rhythms, and sensitivity to light. The main questions it aims to answer are:

  1. Does cannabis use and discontinuation impact sleep drive?
  2. Does cannabis use and discontinuation impact light sensitivity and circadian phase?
Read the detailed description

Researchers will compare sleep, circadian phase, and light sensitivity within regular cannabis users before, during, and after a cannabis discontinuation protocol; researchers will also compare sleep, circadian phase, and light sensitivity between regular cannabis users and control non-cannabis users.

Participants will:

  1. Participate in a 1-week baseline period consisting of at-home monitoring (sleep diaries, actigraphy, EEG headband).
  2. Participate in a 2-night lab visit consisting of circadian phase and light sensitivity assessment.
  3. Participate in a 4-week cannabis discontinuation protocol (cannabis users only).
  4. Participate in a second 2-night lab visit after the discontinuation protocol (cannabis users only).
Being tested
Cannabis Discontinuation
Keywords
cannabis, sleep, circadian rhythms, photosensitivity, cannabis discontinuation
Medical subject headings
Marijuana Abuse, Photosensitivity Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cannabis DiscontinuationBehavioural

    Cannabis-using participants will participate in an orientation session with a clinician and asked to abstain from cannabis use for four weeks, using established procedures for abstinence monitoring and reinforcement.

Study groups in NCT06743373
Study groupRoleWhat they receive
Cannabis-UsingExperimentalThe cannabis-using arm will consist of 60 young people reporting regular cannabis use. Participants will complete a 1-week baseline protocol followed by a 4-week cannabis discontinuation protocol (intervention).
Receives: Behavioral: Cannabis Discontinuation
ControlNo interventionThe control arm will consist of 30 young people without current cannabis use. Participants will complete a 1-week baseline protocol. No intervention will be administered.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Homeostatic Sleep Drive

    Rate of slow wave activity dissipation, assessed by at-home EEG headband. Compared within person (cannabis-using days vs. non using days), between groups (Cannabis-Using, Control) at Baseline, and within-group (Cannabis-Using) between Baseline and Post-discontinuation.

    Measured: Baseline, 1 week

  2. Circadian Photosensitivity

    Light-Induced Melatonin Suppression. Melatonin levels on during a 60-minute light exposure will be compared to melatonin levels on a prior night under dim light conditions (when the dim light melatonin onset was assessed). The primary outcome will be % reduction in melatonin levels. Will be compared between groups (Cannabis-Using, Control) at Baseline and within-group (Cannabis-Using) between Baseline and Post-discontinuation.

    Measured: Discontinuation, 4 weeks

  3. Retinal Responsivity

    Retinal responsivity assessed via pupillometry (specifically the Post-Illumination Pupil Response; PIPR). Will be compared between groups (Cannabis-Using, Control) at Baseline and within group (Cannabis-Using.

    Measured: End of discontinuation, 4 weeks

Secondary outcomes (1)
  1. Circadian phase

    Dim light melatonin onset (DLMO). Compared between groups (Cannabis-Using, Control) at Baseline, and within-group (Cannabis-Using) between Baseline and Post-discontinuation.

    Measured: End of discontinuation, 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2024
  2. Study start13 Mar 2025
  3. Primary completion31 Jan 2029 (estimated)
  4. Study completion30 Apr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06743373
Sponsor's protocol ID
STUDY24050074
Other IDs
1R01DA061223-01
Acronym
CASCILS
Status last verified
Apr 2026
First submitted
15 Dec 2024
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Researchers are currently requesting permission from NIDA to share de-identified data via the National Sleep Research Resource (NSRR), which will determine in part which IPD are included. Researchers anticipate sharing, at a minimum, participant's sociodemographic characteristics and the data required to test our listed primary and secondary aims, including substance use data, as well as data from wrist actigraphy, sleep electroencephalography (EEG), salivary melatonin data, and pupillometry.

Questions about this trial

What is this clinical trial studying?

A study testing Cannabis Discontinuation in people with Cannabis Use and Sleep, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Brant P Hasler, PhD (412-246-6413, haslerbp@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Homeostatic Sleep Drive (time frame: Baseline, 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.

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