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Orexin Antagonist

SUVO for Methamphetamine Addiction

Phase 2
Recruiting
Led By Heather Webber, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 7 days of treatment with suvo, after 7 days of washout, after 7 days of treatment with placebo
Awards & highlights

Study Summary

This trial looks at how a new drug, SUVO, affects sleep, stress, and cravings, and its safety and side effects.

Who is the study for?
This trial is for English-speaking individuals with Methamphetamine (MA) use disorder. Participants must not have severe health issues like heart, lung, liver or kidney diseases, seizures, sleep disorders, or be pregnant/breastfeeding. They shouldn't have a psychiatric condition needing treatment that could affect safety in the trial or be on certain medications like MAO inhibitors.Check my eligibility
What is being tested?
The study aims to see how Suvorexant (SUVO), a medication typically used for insomnia, affects sleep quality, stress levels and drug cravings in people with Methamphetamine addiction compared to a placebo (a substance with no active drug).See study design
What are the potential side effects?
While the specific side effects of SUVO in this context are being studied as part of the trial's purpose, common side effects may include drowsiness, headache, dizziness and potential worsening of depression/suicidal thoughts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 7 days of treatment with suvo, after 7 days of washout, after 7 days of treatment with placebo
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 7 days of treatment with suvo, after 7 days of washout, after 7 days of treatment with placebo for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in amount of cortisol measured
Change in resting state alpha power as assessed by EEG
Change in self-reported sleep as assessed by the PITTSBURGH SLEEP QUALITY INDEX (PSQI)
+5 more
Secondary outcome measures
Change in number of days of Methamphetamine use as assessed by the time line follow back (TLFB) method
Change in number of days of methamphetamine use as assessed by the urine drug screen (UDS)
Change in side effects as assessed by the side effects questionnaire

Trial Design

2Treatment groups
Experimental Treatment
Group I: 1 week SUVO then 1 week PlaceboExperimental Treatment2 Interventions
After 1 week of SUVO treatment there will be 1 week of wash out period before start of placebo
Group II: 1 week Placebo then 1 week SUVOExperimental Treatment2 Interventions
After 1 week of placebo treatment there will be 1 week of wash out period before start of study medication
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,948 Total Patients Enrolled
Heather Webber, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
2 Previous Clinical Trials
81 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I satisfy the credentials for participation in this investigation?

"The criteria for being accepted to this research study is a methamphetamine addiction and an age between 18-65 years old. A total of 12 participants are needed."

Answered by AI

How many participants can join this trial currently?

"Verified. According to information on clinicaltrials.gov, the enrollment phase of this trial is currently underway having been initially posted on March 9th 2023 and most recently updated same date. The study requires a total of 12 participants from 1 centre for participation."

Answered by AI

Has this treatment been certified by the FDA?

"The safety rating of this treatment, based on our internal assessment at Power, is 2. This reflects the fact that there is some data indicating its safety but not any conclusive evidence to support it efficacy yet."

Answered by AI

Does this trial's cohort include individuals aged thirty and over?

"This trial is restricted to patients aged 18-65, while there are 264 trials available for minors and 666 studies catered towards senior citizens."

Answered by AI

Is there an ongoing call for volunteers to join this experiment?

"Affirmative. Details on clinicaltrials.gov indicate that this trial, which was first made public on March 9th 2023, is currently looking for study participants. 12 individuals need to be recruited from 1 medical centre."

Answered by AI

Who else is applying?

What site did they apply to?
The University of Texas Health Science Center at Houston
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have been to 7 treatments centers.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
The Effects of Suvorexant on Sleep, Stress, and Cue-reactivity in Methamphetamine Use Disorder
Heather E. Webber, PhD 2023. "The Effects of Suvorexant on Sleep, Stress, and Cue-reactivity in Methamphetamine Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05711862.
~3 spots leftby Aug 2024
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