The Effects of Suvorexant on Sleep, Stress, and Cue-reactivity in Methamphetamine Use Disorder

The University of Texas System (UT)

Status and phase

Terminated

Phase 2

Conditions

Methamphetamine Use Disorder

Treatments

Drug: Placebo

Drug: suvorexant (SUVO)

Study type

Interventional

Funder types

Other

Identifiers

NCT05711862

HSC-MS-22-0796

Details and patient eligibility

About

The purpose of this study is to determine the effects of SUVO on sleep, stress, and cue reactivity/craving and to evaluate the preliminary safety and side effects profile of suvorexant (SUVO)

Enrollment

7 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Meet DSM-5 criteria for MA use disorder
Be fluent in English and able to understand the consent form

Exclusion criteria

Have an alcohol use disorder or report binge drinking (>7 drinks for women and >14 drinks for men)
Have a greater than mild substance use disorder on any other illicit 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., 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