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Completed

NCT Number: NCT03806296

Delayed Sleep Timing in Teens Study

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.

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Key information

Conditions

Delayed Sleep Phase Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

16 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

About this study

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 laboratory study, the investigators will compare a group of DSP adolescents to a group of normal phase adolescents on behavioral and neuroimaging (fMRI) tasks tapping impulsivity and reward sensitivity, as well as a circadian phase assessment.

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.

NOTE: When this ClinicalTrials.gov protocol was initially submitted, there were some mistakes made. The initial submission focused only on the Experimental study, which thus only included the "DSP group" (aka Late Sleep Timing group), and thus out the Laboratory study along with the "normal phase group" (aka Early/Middle Sleep Timing group). At that time, we also only listed a limited range of the primary outcomes listed in the funded grant, inadvertently leaving out several primary outcomes (weekday sleep duration - actigraph, circadian timing - dim light melatonin onset, neural correlates of reward receipt, and baseline cannabis and alcohol use). Finally, we mistakenly listed cannabis use from the Longitudinal protocol as a secondary outcome when it was actually an exploratory outcome in the funded grant, and thus we removed it.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Increase morning bright light

Other

Participants will wear Re-Timer bright glasses for 30 minutes each morning

Decrease evening blue light

Other

Participants will wear tinted glasses that block blue wavelength light for 2 hours before bed

Sleep scheduling

Behavioral

Participants will advance their weekday bedtime and maintain their weekday risetime on weekends

Monitor sleep, mood, and substance use

Behavioral

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

Primary outcomes

  1. Weekday Sleep Duration - Actigraphy

    Time frame: T1 (1 Week), T2 (2 Weeks)

    Total Sleep Time as determined by wrist actigraphy data (averaged across weekdays during 1 week of T1 and during 2 weeks of T2)

  2. Circadian Timing - Dim Light Melatonin Onset

    Time frame: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.

    Circadian Timing as determined by dim light melatonin onset (DLMO) assessed during saliva sampling using the 4pg/ml threshold.

  3. Circadian Alignment

    Time frame: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday. Based on DLMO assessed on weeknight lab overnight visit, and including the two nights of actigraphy data prior to the lab visit.

    Circadian alignment is operationalized as the interval between the dim light melatonin onset (DLMO) and sleep midpoint based on the prior two nights of actigraphy data.

  4. Reward Motivation (Behavioral)

    Time frame: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.

    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. The adjusted average only includes non-burst trials.

  5. Behavioral Inhibition

    Time frame: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.

    Accuracy on Cued Go/No-Go Task, specifically correct response (withholding response) on No-Go trials following an incongruent Go cue

  6. Neural Correlates of Reward Anticipation

    Time frame: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.

    Activation within the reward network during the Monetary Incentive Delay task. Specifically, activation is defined as bold signal in regions of the reward network (from NeuroSynth) on reward anticipation trials (large reward) versus neutral (no money) trials. Higher values represent increased reactivity to reward, as compared to neutral trials.

  7. Neural Correlates of Reward Receipt

    Time frame: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.

    Monetary Incentive Delay Task: Win Outcome vs No Win contrast within the reward network (from Neurosynth). Higher values represent increased reactivity to reward wins, as compared to neutral trials.

  8. Neural Correlates of Impulse Control

    Time frame: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.

    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 on unsuccessful Stop trials versus successful Go trials. Higher values represent increased activity to unsuccessful Stop versus successful Go trials.

  9. Cannabis Use

    Time frame: Days of cannabis use in 3 months prior to baseline.

    Days of cannabis use based on timeline followback interview administered during baseline interview during consent/diagnostic interview visit.

  10. Alcohol Use

    Time frame: 3 months prior to baseline, based on timeline followback interview.

    Days of alcohol use based on timeline followback interview administered during baseline interview during consent/diagnostic interview visit.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Delayed Sleep Phase and Risk for Adolescent Substance Use

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jan 16, 2019
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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