Delayed Sleep Timing in Teens Study

NCT03806296 | Completed Results DMC

• 2 other identifiers: STUDY19030063R01DA044143
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Delayed Sleep Phase

Keywords

sleep; circadian; adolescence; substance use; reward; impulse control

Outcome Measures

Primary Outcomes (10)

• 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.

Study Arms (3)

Manipulation

EXPERIMENTAL

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; Other: Decrease evening blue light; Behavioral: Sleep scheduling; Behavioral: Monitor sleep, mood, and substance use

Control

ACTIVE COMPARATOR

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

Early/Middle Sleep Timing

NO INTERVENTION

Participants who report a weekend bedtime \<1AM. Participants completed only the 1-week baseline observational protocol (T1)

Interventions

Increase morning bright light OTHER

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

Manipulation

Decrease evening blue light OTHER

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

Manipulation

Sleep scheduling BEHAVIORAL

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

Manipulation

Monitor sleep, mood, and substance use BEHAVIORAL

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

Control; Manipulation

Eligibility Criteria

• Age: 16 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Brant Hasler, PhD
• Organization: University of Pittsburgh School of Medicine

haslerbp@upmc.edu

412-246-6413

Study Officials

• Brant P Hasler, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Model Details: This study combines Laboratory, Experimental, and Longitudinal protocols. The study includes 2 initial groups (Early/Middle Sleep Timing and Late Sleep Timing) that all complete the initial Laboratory (baseline) protocol. The Late Sleep participants are also randomized to complete one of two arms (Manipulation or Control) in the Experimental (intervention) protocol. The Early/Mid Sleep group does not complete the Experimental protocol. Finally, participants are also follow-up assessments through the life of the grant in the Longitudinal protocols.

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 16, 2019
• Study Start: December 3, 2018
• Primary Completion: March 22, 2024
• Study Completion: November 30, 2024
• Last Updated: August 26, 2025
• Results First Posted: August 26, 2025

Record last verified: 2025-08

Locations

US (1)