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OpenTrials
Completed

NCT Number: NCT03226132

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).

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Key information

Conditions

Substance Use Disorders Chemically-Induced Disorders Dyssomnias Insomnia Mental Disorders Nervous System Diseases Posttraumatic Stress Disorder Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance-Related Disorders Trauma and Stressor Related Disorders

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anxiety and Behavioral Health Clinic

Tallahassee, Florida, 32306, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief Behavioral Therapy for Insomnia

Behavioral

Brief Behavioral Therapy for Insomnia

Repeated Contact

Behavioral

Repeated Contact

Primary outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: Change from Baseline to Three Months Follow-Up

  2. PTSD Symptoms (PTSD Checklist-5)

    Time frame: Change from Baseline to Three Months Follow-Up

  3. 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

  4. Substance Use Motives (Marijuana Motives Measure)

    Time frame: Change from Baseline to Three Months Follow-Up

  5. Substance Use Frequency (Timeline Followback)

    Time frame: Change from Baseline to Three Months Follow-Up

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Biobehavioral Mechanisms Underlying Improving Sleep to Reduce Risk for Substance Use Disorder

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 21, 2017
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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