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NCT03226132 · ClinicalTrials.gov registry record · NA
Improving Sleep to Reduce Risk for Substance Use Disorder
A NA study of Insomnia and Posttraumatic Stress Disorder, sponsored by Florida State University.
- Completed
- Registry status
- NA
- Development phase
- 73
- Enrollment target
- 1
- Study location
NCT03226132 is a NA study of Insomnia and Posttraumatic Stress Disorder that has completed, run by Florida State University. The registered enrollment target is 73 participants, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03226132, a NA study of Insomnia and Posttraumatic Stress Disorder, has completed, sponsored by Florida State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 73 participants
- Enrollment target
- 1
- Study location
Study Summary
Substance use disorders (SUDs) are a prevalent and impairing condition, particularly among trauma exposed individuals. The current proposal aims to address the critical need for targeted direct SUD prevention in this population by intervening on a novel, malleable risk factor for SUD common among trauma-exposed individuals: sleep disturbance. Sleep disturbance prospectively predicts the development of SUD and may confer risk for SUD by increasing stress reactivity, decreasing decision-making abilities, and ultimately promoting substance use to relieve negative affect, a core etiological factor in SUD. However, to our knowledge, no experimental studies have determined whether improving sleep leads to reductions in SUD risk. As such, the current study will use a randomized controlled trial design to test the effects of brief behavioral treatment for insomnia (BBTI) against a waitlist control among a sample of trauma-exposed young adults with poor sleep and risk for SUD (N = 60). We aim to determine the direct and indirect effects of condition (BBTI vs. waitlist control) on SUD symptoms, substance use-related problems, coping motives, and posttraumatic stress symptoms through improvements in sleep. Furthermore, we will test direct and indirect effects of condition on theoretically proposed mechanisms underlying the association between sleep disturbance and SUD risk (i.e., stress reactivity, cravings in response to stress).
Conditions Studied
Interventions
- BEHAVIORAL Brief Behavioral Therapy for Insomnia
- BEHAVIORAL Repeated Contact
Study Locations (1)
Florida
- Anxiety and Behavioral Health Clinic - Tallahassee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2017-08-20 |
| Est. Completion | 2018-09-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03226132
The ClinicalTrials.gov registry entry for NCT03226132 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (57% lower). The listed sponsor is Florida State University, which has 219 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Insomnia appearing as the primary indexed condition, and to 2 interventions - of which Brief Behavioral Therapy for Insomnia is the first listed.
NCT03226132 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT03226132 about?
NCT03226132 is a clinical study titled "Improving Sleep to Reduce Risk for Substance Use Disorder". Substance use disorders (SUDs) are a prevalent and impairing condition, particularly among trauma exposed individuals. The current proposal aims to address the critical need for targeted direct SUD prevention in this population by intervening on a novel, malleable risk factor for SUD common among tr...
What is the current status of trial NCT03226132?
This trial is currently completed. It is a NA study. The enrollment target is 73 participants. The study started on 2017-08-20. Estimated completion is 2018-09-01.
What conditions does trial NCT03226132 study?
This clinical trial studies the following conditions: Insomnia, Posttraumatic Stress Disorder, Substance Use Disorders.
What interventions are being tested in trial NCT03226132?
The interventions under investigation include: Brief Behavioral Therapy for Insomnia (BEHAVIORAL), Repeated Contact (BEHAVIORAL).
Who is sponsoring clinical trial NCT03226132?
This trial is sponsored by Florida State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03226132 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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