Improving Sleep to Reduce Risk for Substance Use Disorder

NCT ID: NCT03226132

Last Updated: 2021-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-20
• Study Completion Date: 2018-09-01

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).

Conditions

Substance Use Disorders; Insomnia; Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Brief Behavioral Treatment for Insomnia

Brief Behavioral Treatment for Insomnia

Group Type: EXPERIMENTAL

Brief Behavioral Therapy for Insomnia

Intervention Type: BEHAVIORAL

Brief Behavioral Therapy for Insomnia

Repeated Contact

Repeated Contact

Group Type: ACTIVE_COMPARATOR

Repeated Contact

Intervention Type: BEHAVIORAL

Repeated Contact

Interventions

Brief Behavioral Therapy for Insomnia

Brief Behavioral Therapy for Insomnia

Intervention Type: BEHAVIORAL

Repeated Contact

Repeated Contact

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

Norman Schmidt

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Anxiety and Behavioral Health Clinic

Tallahassee, Florida, United States

Countries

United States

Other Identifiers

Short01

Identifier Type: -

Identifier Source: org_study_id