Clinical trial NCT03226132: 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
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Insomnia
Posttraumatic Stress Disorder
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-07-21
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


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

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Change from Baseline to Three Months Follow-Up
measure: PTSD Symptoms (PTSD Checklist-5)
timeFrame: Change from Baseline to Three Months Follow-Up
measure: Substance Use Disorder Symptoms (Cannabis Use Disorder Identification Test; Structured Clinical Interview for Diagnostic and Statistical Manual [DSM]-5)
timeFrame: Change from Baseline to Three Months Follow-Up
measure: Substance Use Motives (Marijuana Motives Measure)
timeFrame: Change from Baseline to Three Months Follow-Up
measure: Substance Use Frequency (Timeline Followback)
timeFrame: Change from Baseline to Three Months Follow-Up
Secondary outcomes:
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Anxiety and Behavioral Health Clinic
state: Florida
Study officials:
References: