Suvorexant for Opioid/Stimulant Co-use

Opioid Use Disorder Clinical Trial

Official title:

Safety and Efficacy of Suvorexant for Opioid/Stimulant Co-use Among Individuals in Treatment for Opioid Use Disorder (OUD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05546515
• Other study ID #: IRB00341328
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: December 2023
• Source: Johns Hopkins University
• Contact: Kelly E Dunn, Ph.D, M.B.A.
• Phone: 410-550-2254
• Email: kdunn9[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate whether Suvorexant 20mg reduces drug use and craving, and improves sleep and stress among persons with co-occurring opioid use disorder and stimulant use disorder.

Description:

This between-subjects, double-blinded, randomized controlled pilot study will recruit patients who are receiving methadone or buprenorphine treatment for OUD and are using cocaine. Participants will be randomly assigned to receive up to 30-days of Suvorexant (SUVO) or placebo. They will visit the clinic regularly to provide urine drug screens and complete questionnaires and will wear a device that can measure their sleep parameters. We expect that relative to persons who receive placebo, individuals who receive SUVO will 1) be less likely to screen positive for cocaine and/or opioids on urine drug screens, 2) will report lower drug craving, 3) will have longer total sleep time, 4) will report fewer insomnia symptoms, and 5) will report overall lower stress than persons who receive placebo. We also expect that patients will not have side effects from SUVO. These preliminary data will inform whether this FDA-approved medication may help patients stop co-using opioids and stimulants, which can be scaled up to reduce public health consequences related to co-use.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Ages 18-65,

2. Meet criteria for stimulant use disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR)

3. Currently receiving methadone or buprenorphine treatment for OUD and considered to be stable on current dose for at least 30 days

4. Willingness to engage with study protocol

5. Use of birth control (as appropriate)

Exclusion criteria:

1. Psychiatric or medical conditions that are judged by the investigators to interfere with participation or that are contraindicated for use with SUVO

2. Pregnant or breastfeeding

3. Current use of benzodiazepines, tranquilizers, or other schedule IV sleep medications

4. Moderate or severe substance use disorder other than opioid or stimulant use disorder

5. SUVO consumption in the last 30 days

6. Use of medications that are contraindicated with the study

7. Past 30-day suicidal behavior

8. Use of continuous positive airway pressure (CPAP) device for sleep apnea

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders
• Stimulant Use Disorder

Intervention

Drug:
• Suvorexant (dual orexin receptor antagonist)
Participants will be prescribed up to 30 days of SUVO.
• Placebo
Participants will be prescribed up to 30 days of placebo medication.

Locations

Country	Name	City	State
United States	Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid use	Opioid use (measured via uranalysis for qualitative opioid assay) other than prescribed methadone or buprenorphine at scheduled study visits up to 30 days post-randomization (yes vs. no)	Up to 30 days post-randomization
Primary	Cocaine use	Cocaine use (measured via uranalysis for qualitative cocaine assay) at scheduled study visits up to 30 days post-randomization.	Up to 30 days post-randomization
Secondary	Insomnia Severity Index total score	Insomnia severity index total scores at scheduled study visits up to 30 days post-randomization.	Up to 30 days post-randomization
Secondary	Total sleep time	Minutes of total sleep time at scheduled study visits up to 30 days post-randomization.	Up to 30 days post-randomization
Secondary	Visual Analog Rating (0-100) of Opioid Craving	Opioid craving, as measured via an average score on visual analog scales (VAS), at scheduled study visits up to 30 days post-randomization.	Up to 30 days post-randomization
Secondary	Visual Analog Rating (0-100) of Cocaine Craving	Cocaine craving, as measured via an average score on visual analog scales (VAS), collected at scheduled study visits up to 30 days post-randomization.	Up to 30 days post-randomization
Secondary	Perceived Stress Scale Total Score	Perceived stress, measured by the Perceived Stress Scale total score at scheduled study visits up to 30 days post-randomization.	Up to 30 days post-randomization