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Improving Sleep to Reduce Risk for Substance Use Disorder

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03226132
Enrollment
73
Registered
2017-07-21
Start date
2017-08-20
Completion date
2018-09-01
Last updated
2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia, Posttraumatic Stress Disorder, Substance Use Disorders

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).

Interventions

BEHAVIORALRepeated Contact

Repeated Contact

Brief Behavioral Therapy for Insomnia

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Florida State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026