Delayed Sleep Timing in Teens Study

Delayed Sleep Phase Clinical Trial

Official title:

Delayed Sleep Phase and Risk for Adolescent Substance Use

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03806296
• Other study ID #: STUDY19030063
• Secondary ID: R01DA044143
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: October 31, 2024

Study information

• Verified date: May 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 148
• Est. completion date: October 31, 2024
• Est. primary completion date: March 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 19 Years

Eligibility

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)

Related Conditions & MeSH terms

• Delayed Sleep Phase

Intervention

Other:
• Increase morning bright light
Participants will wear Re-Timer bright glasses for 30 minutes each morning
• 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
• Monitor sleep, mood, and substance use
Participants will monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraphy

Locations

Country	Name	City	State
United States	Western Psychiatric Institute and Clinic	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circadian alignment	Interval between dim light melatonin onset and midsleep	Post-manipulation (comparing assessment after ~2-week sleep manipulation to the assessment at baseline)
Primary	Behavioral inhibition	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)
Primary	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.	Post-manipulation (comparing assessment after ~2-week sleep manipulation to the assessment at baseline)
Primary	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 (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)
Primary	Neural correlates of reward anticipation	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	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