Delayed Sleep Timing in Teens Study

April 3, 2024 updated by: Brant Hasler, University of Pittsburgh

Delayed Sleep Phase and Risk for Adolescent Substance Use

This study will (1) comprehensively characterize the substance use disorder (SUD) risk profile associated with adolescent Delayed Sleep Phase (DSP), and (2) probe whether SUD risk is diminished by altering sleep/circadian timing.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Mounting evidence indicates that delayed sleep phase (DSP) may confer risk for adolescent substance use (SU) and SUDs. However, the exact nature of this link and the mechanisms underlying it remain unclear. Circadian misalignment, a mismatch between late sleep hours and early school start times, is a compelling potential contributor to elevated SU in adolescent DSP with plausible neurobehavioral mechanisms. The investigators hypothesize that DSP-associated circadian misalignment decreases impulse control and increases reward sensitivity, thereby increasing SUD risk.

This study will, for the first time, (1) comprehensively characterize the SUD risk profile associated with adolescent DSP, and (2) probe whether SUD risk is diminished by altering sleep/circadian timing. The study will assess both established markers of SUD risk and putative neurobehavioral mechanisms (impulsivity and reward sensitivity). Specifically, the investigators will employ a comprehensive, multi-method approach to examining DSP's role in SUD risk, combining laboratory, experimental, and longitudinal studies. The investigators will recruit a sample of 150 eleventh and twelfth graders (16-19 y/o), divided between 100 DSP and 50 normal phase teens. The investigators will focus on cannabis and alcohol use given their prevalent use in adolescents and evident links to DSP.

In the experimental study, the investigators will probe whether stabilizing circadian phase in the DSP group (n=100) by using sleep scheduling and chronotherapeutic approaches (i.e., dim light in the evening and bright light in the morning) improves sleep and neurobehavioral function relevant to SUD risk.

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kathryn Guo
  • Phone Number: 412-246-6422
  • Email: guok@upmc.edu

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Western Psychiatric Institute and Clinic

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.

Eligibility Criteria

Ages Eligible for Study

16 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 16-19 years
  • Currently in 11th or 12th grade and enrolled in a traditional high-school; or cyber school with synchronous classes (not home-schooled)
  • Physically and psychiatrically healthy, as determined by instruments described below
  • Provision of written informed consent and assent

Additional inclusion criterion for Experimental protocol

  • Meets operational definition of delayed sleep phase (DSP; weekend bedtime ≥1 AM)

Exclusion Criteria:

  • Significant or unstable acute or chronic medical conditions
  • Past or current bipolar disorder or psychotic disorder
  • Past or current substance use disorder other than alcohol use disorder or cannabis use disorder
  • Past month recreational drug use other than alcohol, cannabis, and nicotine
  • Current syndromal sleep disorders other than insomnia and delayed sleep phase disorder
  • Medications that interfere with sleep and/or reward function (antidepressants, and stimulants prescribed for ADHD are permitted)
  • Conditions that would interfere with the MRI procedures (e.g., non-removal ferromagnetic devices)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Manipulation

For ~2 weeks, participants will be asked to adhere to the following:

  • Sleep scheduling--advance bedtime by 1.5 hours ( + sleep duration)
  • Decrease evening blue light exposure via blue blocker goggles (2 h before bed)
  • Increase morning bright light exposure via bright light goggles (30 m after rise)
  • Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
Other: Increase morning bright light
Participants will wear Re-Timer bright glasses for 30 minutes each morning
Other: Decrease evening blue light
Participants will wear tinted glasses that block blue wavelength light for 2 hours before bed
Behavioral: Sleep scheduling
Participants will advance their weekday bedtime and maintain their weekday risetime on weekends
Behavioral: Monitor sleep, mood, and substance use
Participants will monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraphy
Active Comparator: Control

For ~2 weeks, participants will asked to adhere to the following:

- Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
Behavioral: Monitor sleep, mood, and substance use
Participants will monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraphy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circadian alignment
Time Frame: Post-manipulation (comparing assessment after ~2-week sleep manipulation to the assessment at baseline)
Interval between dim light melatonin onset and midsleep
Post-manipulation (comparing assessment after ~2-week sleep manipulation to the assessment at baseline)
Behavioral inhibition
Time Frame: Post-manipulation (comparing assessment after ~2-week sleep manipulation to the assessment at baseline)
Accuracy on Cued Go/No-Go Task, specifically correct response (withholding response) on go trials with no/go target
Post-manipulation (comparing assessment after ~2-week sleep manipulation to the assessment at baseline)
Reward motivation (behavioral)
Time Frame: Post-manipulation (comparing assessment after ~2-week sleep manipulation to the assessment at baseline)
Adjusted average pumps on Balloon Analogue Risk Task, a computerized measure of risk taking behavior in participants are presented with a series of balloons and offered the chance to earn money by pumping each balloon up by clicking a button.
Post-manipulation (comparing assessment after ~2-week sleep manipulation to the assessment at baseline)
Neural correlates of impulse control
Time Frame: Post-manipulation (comparing assessment after ~2-week sleep manipulation to the assessment at baseline)
Activation within the Executive Control Network during the Stop Signal Task. Specifically, activation is defined as bold signal in regions of the Executive Control Network (particularly the inferior frontal gyrus) on correct Stop trials versus correct Go trials.
Post-manipulation (comparing assessment after ~2-week sleep manipulation to the assessment at baseline)
Neural correlates of reward anticipation
Time Frame: Post-manipulation (comparing assessment after ~2-week sleep manipulation to the assessment at baseline)
Activation within the reward network during the Monetary Incentive Delay task. Specifically, activation is defined as bold signals in regions of the reward network (particularly the ventral striatum) on reward anticipation trials versus no money trials.
Post-manipulation (comparing assessment after ~2-week sleep manipulation to the assessment at baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cannabis use
Time Frame: During follow-ups after the manipulation through study completion, up to 5 years
Cannabis use on Time Line Follow Back interview. Specifically, the frequency (# of days) of cannabis use (yes/no) in the past 2 months.
During follow-ups after the manipulation through study completion, up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Brant P Hasler, PhD, 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 Major Dates

Study Start (Actual)

December 3, 2018

Primary Completion (Actual)

March 22, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

January 8, 2019

First Submitted That Met QC Criteria

January 14, 2019

First Posted (Actual)

January 16, 2019

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY19030063
  • R01DA044143 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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