RECRUITING

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

Conditions

Cannabis Use Sleep Circadian Rhythm cannabis circadian rhythms photosensitivity cannabis discontinuation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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?

Official Title

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

Quick Facts

Study Start:2025-03

Study Completion:2029-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06743373

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 25 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Age 18-25 years * Physically and psychiatrically healthy * 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 lifetime history of engaging in daily or near-daily cannabis use over any month-long period. 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	* 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), supplemented by clinical interview and the WHO-DAS 2.0. 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, 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 and nicotine use disorder. * 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 Structured Clinical Interview for Sleep Disorders, Revised Version (SCISD-R). 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/SSNIs, 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.

Inclusion Criteria

Exclusion Criteria

* Age 18-25 years
* Physically and psychiatrically healthy
* 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 lifetime history of engaging in daily or near-daily cannabis use over any month-long period. 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

* 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), supplemented by clinical interview and the WHO-DAS 2.0. 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, 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 and nicotine use disorder.
* 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 Structured Clinical Interview for Sleep Disorders, Revised Version (SCISD-R). 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/SSNIs, 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.

Contacts and Locations

Study Contact

Brant P Hasler, PhD

CONTACT

412-246-6413

haslerbp@upmc.edu

Principal Investigator

Brant P Hasler, PhD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

Western Psychiatric Hospital (Thomas Detre Hall)

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

Brant P Hasler, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03

Study Completion Date2029-04-30

Study Record Updates

Study Start Date2025-03

Study Completion Date2029-04-30

Terms related to this study

Keywords Provided by Researchers

cannabis
sleep
circadian rhythms
photosensitivity
cannabis discontinuation

Additional Relevant MeSH Terms

Cannabis Use
Sleep
Circadian Rhythm