Improving Sleep to Reduce Risk for Substance Use Disorder

Sponsor

Florida State University (Other)

Overall Status

Completed

CT.gov ID

NCT03226132

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Location

Arms

12.4

Actual Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Substance Use Disorders Insomnia Posttraumatic Stress Disorder	Behavioral: Brief Behavioral Therapy for Insomnia Behavioral: Repeated Contact	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

73 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 20, 2017

Actual Primary Completion Date :

Sep 1, 2018

Actual Study Completion Date :

Sep 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Brief Behavioral Treatment for Insomnia Brief Behavioral Treatment for Insomnia	Behavioral: Brief Behavioral Therapy for Insomnia Brief Behavioral Therapy for Insomnia
Active Comparator: Repeated Contact Repeated Contact	Behavioral: Repeated Contact Repeated Contact

Arm

Intervention/Treatment

Experimental: Brief Behavioral Treatment for Insomnia

Brief Behavioral Treatment for Insomnia

Behavioral: Brief Behavioral Therapy for Insomnia

Brief Behavioral Therapy for Insomnia

Active Comparator: Repeated Contact

Repeated Contact

Behavioral: Repeated Contact

Repeated Contact

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anxiety and Behavioral Health Clinic	Tallahassee	Florida	United States	32306

Sponsors and Collaborators

Florida State University
National Institute on Drug Abuse (NIDA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Norman Schmidt, Professor, Florida State University

ClinicalTrials.gov Identifier:

NCT03226132

Other Study ID Numbers:

Short01

First Posted:

Jul 21, 2017

Last Update Posted:

Feb 1, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Disease

Substance-Related Disorders

Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Feb 1, 2021