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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-09

Study Completion Date

2024-03-28

Brief Summary

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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)

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Detailed Description

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Conditions

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Methamphetamine Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1 week Placebo, then 1 week suvorexant (SUVO)

After 1 week of placebo treatment there will be 1 week of wash out period before start of study medication

Group Type EXPERIMENTAL

suvorexant (SUVO)

Intervention Type DRUG

Participants will receive 20mg of SUVO for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.

Placebo

Intervention Type DRUG

Participants will receive 0mg of placebo for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.

1 week suvorexant (SUVO), then 1 week Placebo

After 1 week of SUVO treatment there will be 1 week of wash out period before start of placebo

Group Type EXPERIMENTAL

suvorexant (SUVO)

Intervention Type DRUG

Participants will receive 20mg of SUVO for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.

Placebo

Intervention Type DRUG

Participants will receive 0mg of placebo for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.

Interventions

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suvorexant (SUVO)

Participants will receive 20mg of SUVO for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.

Intervention Type DRUG

Placebo

Participants will receive 0mg of placebo for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No