NCT06444256PHASE2Recruiting
Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder
The University of Texas Health Science Center, Houston
Start Date
7/25/2024
Completion Date
1/30/2027
Summary
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.
Eligibility Criteria
Age Range: 18 years to 65 years
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
Interventions
DRUG
SUVO
DRUG
TAU
Conditions
Stimulant Use Disorder
Locations
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United States