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

NCT06743373 | Recruiting

• 2 other identifiers: STUDY240500741R01DA061223-01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does cannabis use and discontinuation impact sleep drive?
2. 2.Does cannabis use and discontinuation impact light sensitivity and circadian phase?

Conditions

Cannabis Use; Sleep; Circadian Rhythm

Keywords

cannabis; sleep; circadian rhythms; photosensitivity; cannabis discontinuation

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• Circadian phase

  End of discontinuation, 4 weeks

Study Arms (2)

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).

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.

Interventions

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.

Cannabis-Using

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Western Psychiatric Hospital (Thomas Detre Hall)

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Marijuana Abuse; Photosensitivity Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Brant P Hasler, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brant P Hasler, PhD

CONTACT

412-246-6413; haslerbp@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry, Psychology, and Clinical and Translational Science

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 19, 2024
• Study Start: March 13, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 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.
• Access Criteria: 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.

Locations

US (1)