TerminatedPhase 2

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

Stopped: Lack of enrollment

United States7 participantsStarted 2023-03-09

Plain-language summary

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)

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Self-reported Sleep as Assessed by the PITTSBURGH SLEEP QUALITY INDEX (PSQI)

Timeframe: 7 days

Resting State Alpha Power as Assessed by EEG

Timeframe: 7 days

Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by the EEG

Timeframe: 7 days

Self-reported Stress as Assessed by the Stress Subscale of the Depression, Anxiety and Stress Scale (DASS-21)

Timeframe: 7 days

Self-reported Stress as Assessed by the Visual Analog Scale (VAS)

Timeframe: 7 days

Change of Cortisol Level

Timeframe: baseline, about 32 minutes after the start of the cold pressor task

Average Sleep Time Per Night Measured Nightly Via Actigraphy Watch Over 7 Nights

Timeframe: 7 days

Trial details

NCT IDNCT05711862

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-28

Results submitted2025-03-26

View on ClinicalTrials.gov More Methamphetamine Use Disorder trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Self-reported Sleep as Assessed by the PITTSBURGH SLEEP QUALITY INDEX (PSQI)

Timeframe: 7 days

Resting State Alpha Power as Assessed by EEG

Timeframe: 7 days

Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by the EEG

Timeframe: 7 days

Self-reported Stress as Assessed by the Stress Subscale of the Depression, Anxiety and Stress Scale (DASS-21)

Timeframe: 7 days

Self-reported Stress as Assessed by the Visual Analog Scale (VAS)

Timeframe: 7 days

Change of Cortisol Level

Timeframe: baseline, about 32 minutes after the start of the cold pressor task

Average Sleep Time Per Night Measured Nightly Via Actigraphy Watch Over 7 Nights

Timeframe: 7 days