Delayed Sleep Timing in Teens Study

Sponsor
University of Pittsburgh (Other)
Overall Status
Recruiting
CT.gov ID
NCT03806296
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
150
1
2
52.9
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Increase morning bright light
  • Other: Decrease evening blue light
  • Behavioral: Sleep scheduling
  • Behavioral: Monitor sleep, mood, and substance use
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Delayed Sleep Phase and Risk for Adolescent Substance Use
Actual Study Start Date :
Dec 3, 2018
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Circadian alignment [Post-manipulation (comparing assessment after ~2-week sleep manipulation to the assessment at baseline)]

    Interval between dim light melatonin onset and midsleep

  2. Behavioral inhibition [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

  3. Reward motivation (behavioral) [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.

  4. Neural correlates of impulse control [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.

  5. Neural correlates of reward anticipation [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.

Secondary Outcome Measures

  1. Cannabis use [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 19 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Western Psychiatric Institute and Clinic Pittsburgh Pennsylvania United States 15213

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Brant P Hasler, PhD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Brant Hasler, Assistant Professor of Psychiatry, Psychology, and Clinical and Translational Science, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT03806296
Other Study ID Numbers:
  • PRO18010292
  • R01DA044143
First Posted:
Jan 16, 2019
Last Update Posted:
Mar 2, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Brant Hasler, Assistant Professor of Psychiatry, Psychology, and Clinical and Translational Science, University of Pittsburgh

Study Results

No Results Posted as of Mar 2, 2022