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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
United States1 site, 1 recruiting
- Recruiting
Western Psychiatric Hospital (Thomas Detre Hall)
Pittsburgh, Pennsylvania, 15213
Brant P Hasler, PhD, 412-246-6413, haslerbp@upmc.edu
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:
- Does cannabis use and discontinuation impact sleep drive?
- 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:
- Participate in a 1-week baseline period consisting of at-home monitoring (sleep diaries, actigraphy, EEG headband).
- Participate in a 2-night lab visit consisting of circadian phase and light sensitivity assessment.
- Participate in a 4-week cannabis discontinuation protocol (cannabis users only).
- Participate in a second 2-night lab visit after the discontinuation protocol (cannabis users only).
- Conditions
- Cannabis Use, Sleep, Circadian Rhythm
- 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 group | Role | What they receive |
|---|---|---|
| Cannabis-Using | Experimental | The 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 |
| Control | No intervention | The 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.
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
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
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)
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.
- First posted19 Dec 2024
- Study start13 Mar 2025
- Primary completion31 Jan 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Brant Hasler, University of Pittsburgh
- Investigators
- Brant P Hasler, PhD, Principal investigator, University of Pittsburgh
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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabis Effects on Sleep, Circadian Rhythms, and Light Sensitivity in Young Adults (CASCILS)
- ClinicalTrials.gov ID
- NCT06743373
- Acronym / sponsor ID
- CASCILS / STUDY24050074
- Conditions
- Cannabis Use, Sleep, Circadian Rhythm
- Keywords
- cannabis, sleep, circadian rhythms, photosensitivity, cannabis discontinuation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does cannabis use and discontinuation impact sleep drive?
- Does cannabis use and discontinuation impact light sensitivity and circadian phase?
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:
- Participate in a 1-week baseline period consisting of at-home monitoring (sleep diaries, actigraphy, EEG headband).
- Participate in a 2-night lab visit consisting of circadian phase and light sensitivity assessment.
- Participate in a 4-week cannabis discontinuation protocol (cannabis users only).
- Participate in a second 2-night lab visit after the discontinuation protocol (cannabis users only).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabis-Using | Experimental | Behavioral: Cannabis DiscontinuationThe 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). |
| Control | No intervention | –The 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabis DiscontinuationCannabis-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. | Behavioural | Cannabis-Using |
Primary outcome
Homeostatic Sleep Drive
Time frame: Baseline, 1 week
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.
Circadian Photosensitivity
Time frame: Discontinuation, 4 weeks
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.
Retinal Responsivity
Time frame: End of discontinuation, 4 weeks
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.
1 secondary outcome
Circadian phase
Time frame: End of discontinuation, 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brant P Hasler, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
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.