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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA061223-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabis Discontinuation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | End of discontinuation, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | End of discontinuation, 4 weeks |
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List the inclusion criteria:
List the exclusion criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brant P Hasler, PhD | Contact | 412-246-6413 | haslerbp@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Brant P Hasler, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Psychiatric Hospital (Thomas Detre Hall) | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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.
If researchers use the NSRR as planned, the research community will have access to data at the end of the grant award and/or when a publication has been submitted. Once the data are submitted to NSRR, the NSRR platform will control the long-term persistence of the data set. Currently, NSRR has no process for deleting or retiring data sets and has created a stable and sustainable infrastructure that will allow currently hosted data to stay available through the lifetime of the repository.
To request access to study data on the NSRR, researchers would use the standard processes that includes research proposal submission and review by the NSRR Data Access Review Committee. The standard NSRR data access process allows time limited access and is renewable. Written requests from qualified investigators will be submitted on a standardized data request and analysis form, which will then be reviewed by PI Hasler. All data requests will be logged in a repository tracking log. IRB and/or Data Use Agreements (as appropriate) will be put in place before any transfer of data. Investigators receiving the data much abide by the conditions of these agreements.
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| D010787 | Photosensitivity Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D012871 | Skin Diseases |
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| D017437 | Skin and Connective Tissue Diseases |