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
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.