Sleep drug shows promise for dual diagnosis of alcoholism and PTSD
NCT ID NCT06679062
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 study tests whether the sleep medication suvorexant can reduce insomnia in 76 adults aged 21–65 who have both alcohol use disorder and posttraumatic stress disorder. Participants take either suvorexant or a placebo for 14 days while trying to stop drinking. The study measures changes in sleep quality and alcohol cravings.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- suvorexant
- What this could lead to
- If it works, this could point toward a new way to treat insomnia in people with both alcohol use disorder and PTSD, potentially helping them reduce drinking.
- What could go wrong
- This is a small, early-phase trial with only 76 people and a short 14-day treatment period. Results may not apply to everyone, and suvorexant may not work better than placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 76 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * A current (past 12-month at Day -7/-6) DSM-5 diagnosis via the MINI of substance use disorder for any substances other than alcohol, nicotine, or marijuana (\< moderate level on DSM 5). * A lifetime DSM-5 diagnosis via the MINI of schizophrenia, bipolar disorder, or psychotic disorder. * Positive urine test for any recreational drugs other than marijuana at screening (Day -7/-6). * Current clinically significant alcohol withdrawal (i.e., score ≥ 10 on the CIWA-Ar). * Currently pregnant, nursing, or no reliable method of birth control (females only). * Any clinically significant medical condition that would preclude safe participation in the study (e.g. narcolepsy, seizure disorder, or other clinically significant cardiovascular, hematologic, hepatic, renal, neurological, or endocrine disorders). * Use of suvorexant (within 30 days of Day -7). * Currently on prescription medication that contraindicates use of suvorexant (including moderate or strong Cytochrome P450 3A modulators (CYP3A inhibitors and inducers)) * Hepatic insufficiency (AST/ALT \> 5x upper limit of normal (ULN)). * Suicidal Ideation determined by greater than moderate Columbia Suicide Severity Rating Scale. * Inability to provide evidence of 48-hour alcohol abstinence (self-report, BrAC, EtG) at Day 0 AND failure after second attempt at 48-hour abstinence.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The University of Texas Health Science Center - Houston
RECRUITINGHouston, Texas, 77054, United States
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University of California - Los Angeles
RECRUITINGLos Angeles, California, 90095, United States
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- Can fixing insomnia help heavy drinkers cut back?