Status:

RECRUITING

Experimental Manipulation of Sleep and Circadian Rhythms and the Role Played on Reward Function in Teens

Lead Sponsor:

University of Pittsburgh

Collaborating Sponsors:

National Institute on Drug Abuse (NIDA)

Conditions:

Delayed Sleep Phase Syndrome

Eligibility:

All Genders

13-15 years

Phase:

NA

Brief Summary

Adolescence is a time of heightened reward sensitivity and greater impulsivity. On top of this, many teenagers experience chronic sleep deprivation and misalignment of their circadian rhythms due to b...

Detailed Description

Substance use (SU) and substance use disorders (SUD) pose devastating health, financial, and societal costs. The incidence of SU and SUDs increases across adolescence, making this sensitive developmen...

Eligibility Criteria

Inclusion

  • Typically enrolled in a traditional high-school with synchronous learning (in-person or online synchronous learning, but not cyber- or home-schooling) \[school closures during the COVID-19 pandemic are an exception to this\]
  • Physically and psychiatrically healthy
  • Provision of written informed consent and assent
  • Additional inclusion criterion for Experimental protocol: Meets operational definition of late sleep timing (\>10:50PM habitual bedtime)

Exclusion

  • History of alcohol, cannabis, or illicit drug use in the past month, or greater than monthly use in the past year
  • Significant or unstable acute or chronic medical conditions
  • Frequent headaches or migraines
  • History of seizures
  • Current serious psychiatric disorder (e.g., depressive disorder, bipolar disorder, eating disorder, psychotic disorder diagnosis, alcohol use disorder or substance use disorder) that would interfere with completion of study procedures
  • Current syndromal sleep disorders other than insomnia and delayed sleep phase disorder
  • MRI contraindications (i.e., absence of metal in the body, claustrophobia)
  • Medications that increase sensitivity to blue light/photosensitizing medications, including psychiatric neuroleptic drugs, psoralen drugs, antiarrhythmic drugs, etc.
  • Changes to psychotropic medication regimen in the 2 weeks prior to enrollment, and/or major changes to medications during the study protocol
  • If participants have an average bedtime that is later than 3:00AM or an average wake time later than 11:00AM they may be excluded from the study
  • Participants should be EXCLUDED for other sleep disorders that require ongoing treatment
  • Participants should be EXCLUDED for other sleep disorders that cause significant distress or impairment, per DSM 5 criteria in the Sleep SCID.

Key Trial Info

Start Date :

May 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2026

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT04792697

Start Date

May 1 2021

End Date

June 30 2026

Last Update

November 12 2025

Active Locations (1)

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1

Western Psychiatric Hospital

Pittsburgh, Pennsylvania, United States, 15213