Delayed Sleep Timing in Teens Study

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: Completed
• Conditions: Delayed Sleep Phase
• Intervention / Treatment: Other: Increase morning bright light; Other: Decrease evening blue light; Behavioral: Sleep scheduling; Behavioral: Monitor sleep, mood, and substance use

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 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.

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manipulation; Participants who reported a weekend bedtime ≥ 1 AM. Completed both a 1-week baseline period (T1) and a 2-week experimental period (T2). During the 2-week experimental period, participants were 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; Participants who reported a weekend bedtime ≥ 1 AM. Completed both a 1-week baseline period (T1) and a 2-week experimental period (T2). During the 2-week experimental period, participants were 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
No Intervention: Early/Middle Sleep Timing; Participants who report a weekend bedtime <1AM. Participants completed only the 1-week baseline observational protocol (T1)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weekday Sleep Duration - Actigraphy	Total Sleep Time as determined by wrist actigraphy data (averaged across weekdays during 1 week of T1 and during 2 weeks of T2)	T1 (1 Week), T2 (2 Weeks)
Circadian Timing - Dim Light Melatonin Onset	Circadian Timing as determined by dim light melatonin onset (DLMO) assessed during saliva sampling using the 4pg/ml threshold.	Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.
Circadian Alignment	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.	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.
Reward Motivation (Behavioral)	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.	Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.
Behavioral Inhibition	Accuracy on Cued Go/No-Go Task, specifically correct response (withholding response) on No-Go trials following an incongruent Go cue	Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.
Neural Correlates of Reward Anticipation	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.	Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.
Neural Correlates of Reward Receipt	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.	Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.
Neural Correlates of Impulse Control	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.	Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.
Cannabis Use	Days of cannabis use based on timeline followback interview administered during baseline interview during consent/diagnostic interview visit.	Days of cannabis use in 3 months prior to baseline.
Alcohol Use	Days of alcohol use based on timeline followback interview administered during baseline interview during consent/diagnostic interview visit.	3 months prior to baseline, based on timeline followback interview.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cannabis use	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

• Sponsor: University of Pittsburgh
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Brant P Hasler, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Actual): March 22, 2024
• Study Completion (Actual): November 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 (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: sleep; circadian; reward; adolescence; substance use; impulse control
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• 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
• product manufactured in and exported from the U.S.: No