Improving Sleep to Reduce Risk for Substance Use Disorder

Biobehavioral Mechanisms Underlying 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 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).

Study Overview

• Status: Completed
• Conditions: Insomnia; Substance Use Disorders; Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: Brief Behavioral Therapy for Insomnia; Behavioral: Repeated Contact

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32306
      • Anxiety and Behavioral Health Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brief Behavioral Treatment for Insomnia	Behavioral: Brief Behavioral Therapy for Insomnia; Brief Behavioral Therapy for Insomnia
Active Comparator: Repeated Contact	Behavioral: Repeated Contact; Repeated Contact

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Insomnia Severity Index (ISI)	Change from Baseline to Three Months Follow-Up
PTSD Symptoms (PTSD Checklist-5)	Change from Baseline to Three Months Follow-Up
Substance Use Disorder Symptoms (Cannabis Use Disorder Identification Test; Structured Clinical Interview for Diagnostic and Statistical Manual [DSM]-5)	Change from Baseline to Three Months Follow-Up
Substance Use Motives (Marijuana Motives Measure)	Change from Baseline to Three Months Follow-Up
Substance Use Frequency (Timeline Followback)	Change from Baseline to Three Months Follow-Up

Collaborators and Investigators

• Sponsor: Florida State University
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2017
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: July 13, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Substance-Related Disorders; Disease; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: Short01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No