Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Suvorexant for Alcohol Use Disorder (AUD)

This study is to determine if suvorexant (SUV) will reduce insomnia in 76 men and women veteran and non-veterans between the ages 21-65 with posttraumatic stress disorder (PTSD) symptoms and alcohol use disorder (AUD). All participants will have a 7-day dummy treatment (placebo) run-in period, followed by a random assignment to receive dummy treatment (placebo) or suvorexant for an additonal 14 days.

Official registry: https://clinicaltrials.gov/study/NCT06679062 · Pharmacotherapies for Alcohol and Substance Use Disorders Alliance · enrollment listed as 76

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Suvorexant, or Placebo. The registry lists allocation as randomized. This study is to determine if suvorexant (SUV) will reduce insomnia in 76 men and women veteran and non-veterans between the ages 21-65 with posttraumatic stress disorder (PTSD) symptoms and alcohol use disorder (AUD).

They plan to enroll about 76 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Double-masked, Randomized, Phase II Study to Compare the Effectiveness of 20mg Oral Suvorexant (SUV) Versus Placebo (1:1) in Participants With Co-occurring Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD)

Interventions: Suvorexant, Placebo

Primary outcome (registry wording): Change in Insomnia Severity Index (ISI) score from baseline to Day 14.

Who it is for (from inclusion criteria)

  • Ages 21 Years to 65 Years
  • Age between 21 and 65
  • Meet current (i.e., past 12-month at Day -7/-6) DSM-5 diagnostic criteria for moderate or severe AUD as determined by the MINI
  • Currently experiencing PTSD symptoms at screening (Day -7/-6) as indicated by PCL-5 cut-score \> 30
  • Intrinsic motivation to reduce or quit drinking (defined as self-reported intention at screening to reduce or quit drinking within the next 6 months) and to receive PTSD treatment
  • Must have an ISI score equal to or \> 7 (subthreshold insomnia). ISI score below 7 at screening will not be included or proceed beyond the screening day
  • Agree to abstain from all other sleep medications (starting at Day -7)
  • Have a place to live in the 2 weeks prior to randomization (Day 0) and not be at risk that s/he will lose his/her housing in the next month

Public study contact (from the registry)

Scott Lane, PhD

713-486-2535

scott.d.lane@uth.tmc.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

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FAQ about this NCT record

Is NCT06679062 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06679062?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06679062?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary