Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-25

Study Completion Date

2027-01-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Stimulant Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SUVO

Group Type EXPERIMENTAL

SUVO

Intervention Type DRUG

Participants will receive 20mg of SUVO for 7 days in the evening before bed on Day 5 through Day 11

TAU

Intervention Type DRUG

Participants will receive supportive care and symptomatic medication per protocol at the inpatient facility.

TAU

Group Type ACTIVE_COMPARATOR

TAU

Intervention Type DRUG

Participants will receive supportive care and symptomatic medication per protocol at the inpatient facility.

Interventions

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SUVO

Participants will receive 20mg of SUVO for 7 days in the evening before bed on Day 5 through Day 11

Intervention Type DRUG

TAU

Participants will receive supportive care and symptomatic medication per protocol at the inpatient facility.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No