Improving Sleep to Reduce Risk for Substance Use Disorder

NCT03226132 | Completed

• 1 other identifier: Short01
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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).

Conditions

Substance Use Disorders; Insomnia; Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Brief Behavioral Treatment for Insomnia

EXPERIMENTAL

Brief Behavioral Treatment for Insomnia

Behavioral: Brief Behavioral Therapy for Insomnia

Repeated Contact

ACTIVE COMPARATOR

Repeated Contact

Behavioral: Repeated Contact

Interventions

Brief Behavioral Therapy for Insomnia BEHAVIORAL

Brief Behavioral Therapy for Insomnia

Brief Behavioral Treatment for Insomnia

Repeated Contact BEHAVIORAL

Repeated Contact

Repeated Contact

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Florida State University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Anxiety and Behavioral Health Clinic

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Sleep Initiation and Maintenance Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 21, 2017
• Study Start: August 20, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)