Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder

The University of Texas System (UT)

Status and phase

Enrolling

Phase 2

Conditions

Stimulant Use Disorder

Treatments

Drug: SUVO

Drug: TAU

Study type

Interventional

Funder types

Other

Identifiers

NCT06444256

HSC-MS-24-0330

Details and patient eligibility

About

The purpose of this study is to determine the effects of suvorexant (SUVO), on sleep, stress, and drug craving during early abstinence from stimulants and to determine the effects of treatment (SUVO vs. treatment as usual (TAU)) on post-treatment (Days 13-30) residential program length of stay (LOS) and completion rate.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Meet Diagnostic and Statistical Manual of Mental Disorders(DSM-5)criteria for primary stimulant use disorder (either cocaine or methamphetamine)
Be fluent in English and able to understand the consent form

Exclusion criteria

Have an opioid use disorder of any severity
Have a greater than moderate substance use disorder on any other substance
Undergoing medication-assisted treatment for withdrawal of any substance
Have any medical conditions contraindicating SUVO (e.g., severe pulmonary disease, severe cardiovascular disease or clinically abnormal ECG, severe liver or kidney disease, seizure disorder, or sleep disorder -particularly narcolepsy)
Are currently taking medications with known drug interactions with SUVO (e.g., Monoamine oxidase (MAO) inhibitors, anticonvulsants, haloperidol, phenothiazines, anesthetics, and any sedative)
Are pregnant or breast feeding
BMI > 30 (women only)
Have a current DSM-5 psychiatric disorder or neurological disease requiring on-going treatment that would make participation unsafe
Have history of seizure disorder
Have a head injury with loss of consciousness in the last 5 years