Clinical trial NCT03806296: Delayed Sleep Timing in Teens Study
Official title: Delayed Sleep Phase and Risk for Adolescent Substance Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delayed Sleep Phase
Keywords: sleep
circadian
adolescence
substance use
reward
impulse control
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-01-16
Enrollment: 148
Sex: ALL
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Circadian alignment
timeFrame: Post-manipulation (comparing assessment after ~2-week sleep manipulation to the assessment at baseline)
measure: Behavioral inhibition
timeFrame: Post-manipulation (comparing assessment after ~2-week sleep manipulation to the assessment at baseline)
measure: Reward motivation (behavioral)
timeFrame: Post-manipulation (comparing assessment after ~2-week sleep manipulation to the assessment at baseline)
measure: Neural correlates of impulse control
timeFrame: Post-manipulation (comparing assessment after ~2-week sleep manipulation to the assessment at baseline)
measure: Neural correlates of reward anticipation
timeFrame: Post-manipulation (comparing assessment after ~2-week sleep manipulation to the assessment at baseline)
Secondary outcomes:
measure: Cannabis use
timeFrame: During follow-ups after the manipulation through study completion, up to 5 years
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute and Clinic
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Brant P Hasler, PhD
role: PRINCIPAL_INVESTIGATOR
References: