Improving Sleep to Reduce Risk for Substance Use Disorder

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03226132
• Other study ID #: Short01
• Status: Completed
• Phase: N/A
• Start date: August 20, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: January 2021
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Insomnia
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Brief Behavioral Therapy for Insomnia
Brief Behavioral Therapy for Insomnia
• Repeated Contact
Repeated Contact

Locations

Country	Name	City	State
United States	Anxiety and Behavioral Health Clinic	Tallahassee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida State University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia Severity Index (ISI)		Change from Baseline to Three Months Follow-Up
Primary	PTSD Symptoms (PTSD Checklist-5)		Change from Baseline to Three Months Follow-Up
Primary	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
Primary	Substance Use Motives (Marijuana Motives Measure)		Change from Baseline to Three Months Follow-Up
Primary	Substance Use Frequency (Timeline Followback)		Change from Baseline to Three Months Follow-Up