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Improving Sleep to Reduce Risk for Substance Use Disorder

Primary Purpose

Substance Use Disorders, Insomnia, Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Behavioral Therapy for Insomnia
Repeated Contact
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use Disorders

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Trauma exposure
  • Current cannabis use
  • Insomnia symptoms
  • Age 18-30

Exclusion Criteria:

  • Severe substance use disorder
  • Receiving treatment related to sleep or substance use

Sites / Locations

  • Anxiety and Behavioral Health Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Brief Behavioral Treatment for Insomnia

Repeated Contact

Arm Description

Brief Behavioral Treatment for Insomnia

Repeated Contact

Outcomes

Primary Outcome Measures

Insomnia Severity Index (ISI)
PTSD Symptoms (PTSD Checklist-5)
Substance Use Disorder Symptoms (Cannabis Use Disorder Identification Test; Structured Clinical Interview for Diagnostic and Statistical Manual [DSM]-5)
Substance Use Motives (Marijuana Motives Measure)
Substance Use Frequency (Timeline Followback)

Secondary Outcome Measures

Full Information

First Posted
July 13, 2017
Last Updated
January 27, 2021
Sponsor
Florida State University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03226132
Brief Title
Improving Sleep to Reduce Risk for Substance Use Disorder
Official Title
Biobehavioral Mechanisms Underlying Improving Sleep to Reduce Risk for Substance Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 20, 2017 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, Insomnia, Posttraumatic Stress Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief Behavioral Treatment for Insomnia
Arm Type
Experimental
Arm Description
Brief Behavioral Treatment for Insomnia
Arm Title
Repeated Contact
Arm Type
Active Comparator
Arm Description
Repeated Contact
Intervention Type
Behavioral
Intervention Name(s)
Brief Behavioral Therapy for Insomnia
Intervention Description
Brief Behavioral Therapy for Insomnia
Intervention Type
Behavioral
Intervention Name(s)
Repeated Contact
Intervention Description
Repeated Contact
Primary Outcome Measure Information:
Title
Insomnia Severity Index (ISI)
Time Frame
Change from Baseline to Three Months Follow-Up
Title
PTSD Symptoms (PTSD Checklist-5)
Time Frame
Change from Baseline to Three Months Follow-Up
Title
Substance Use Disorder Symptoms (Cannabis Use Disorder Identification Test; Structured Clinical Interview for Diagnostic and Statistical Manual [DSM]-5)
Time Frame
Change from Baseline to Three Months Follow-Up
Title
Substance Use Motives (Marijuana Motives Measure)
Time Frame
Change from Baseline to Three Months Follow-Up
Title
Substance Use Frequency (Timeline Followback)
Time Frame
Change from Baseline to Three Months Follow-Up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Trauma exposure Current cannabis use Insomnia symptoms Age 18-30 Exclusion Criteria: Severe substance use disorder Receiving treatment related to sleep or substance use
Facility Information:
Facility Name
Anxiety and Behavioral Health Clinic
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Improving Sleep to Reduce Risk for Substance Use Disorder

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