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Monitor sleep, mood, and substance use for Delayed Sleep Phase Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Delayed Sleep Phase SyndromeMonitor sleep, mood, and substance use - Behavioral
Eligibility
16 - 19
All Sexes
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Study Summary

This trial will study whether sleep disorders in adolescence are linked to an increased risk of substance abuse, and whether treatment can help.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

5 Primary · 1 Secondary · Reporting Duration: During follow-ups after the manipulation through study completion, up to 5 years

Year 5
Cannabis use
Post-manipulation (comparing assessment after ~2-week sleep manipulation to the assessment at baseline)
Behavioral inhibition
Circadian alignment
Neural correlates of impulse control
Neural correlates of reward anticipation
Reward motivation (behavioral)

Trial Safety

Safety Progress

1 of 3

Similar Trials

3
Lemborexant
1
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1
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Trial Design

2 Treatment Groups

Control
1 of 2
Manipulation
1 of 2

Active Control

Experimental Treatment

150 Total Participants · 2 Treatment Groups

Primary Treatment: Monitor sleep, mood, and substance use · No Placebo Group · N/A

ManipulationExperimental Group · 4 Interventions: Increase morning bright light, Decrease evening blue light, Monitor sleep, mood, and substance use, Sleep scheduling · Intervention Types: Other, Other, Behavioral, Behavioral
Control
Behavioral
ActiveComparator Group · 1 Intervention: Monitor sleep, mood, and substance use · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleep scheduling
2009
Completed Phase 2
~70

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: during follow-ups after the manipulation through study completion, up to 5 years

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,250 Previous Clinical Trials
2,029,142 Total Patients Enrolled
1 Trials studying Delayed Sleep Phase Syndrome
100 Patients Enrolled for Delayed Sleep Phase Syndrome
University of PittsburghLead Sponsor
1,617 Previous Clinical Trials
16,299,584 Total Patients Enrolled
1 Trials studying Delayed Sleep Phase Syndrome
100 Patients Enrolled for Delayed Sleep Phase Syndrome
Brant P Hasler, PhDPrincipal InvestigatorUniversity of Pittsburgh

Eligibility Criteria

Age 16 - 19 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Ages 16-19 years account for 8% of all motor vehicle crashes
Currently in 11th or 12th grade and enrolled in a traditional high school or cyber school with synchronous classes (not home-schooled).
The person is in good physical and mental health, as determined by the tools below.
convenience The study's participants will be asked to provide written consent and assent as well as meet any additional inclusion criteria defined by the experimental protocol
The person has a delayed sleep phase, which is defined as going to bed after 1am on weekends.
References

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