Suvorexant for Treatment of AUD and PTSD

A vizsgálat adatai

Ki végzi

Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

Azonosító

NCT06679062

A regiszteradat frissítve

2026. október 14.

Eredeti leírás

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 placebo run-in period, followed by a random assignment to receive placebo or suvorexant for an additonal 14 days. Post-randomization, participants will attempt to stop drinking for two weeks and will complete daily virtual diaries and study outcome assessments via in-person clinic visits on days 7 and 14.A teljes eredeti leírásKevesebb

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)

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 placebo run-in period, followed by a random assignment to receive placebo or suvorexant for an additonal 14 days. Post-randomization, participants will attempt to stop drinking for two weeks and will complete daily virtual diaries and study outcome assessments via in-person clinic visits on days 7 and 14.

Bevonási feltételek: 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.

Kizáró feltételek: Positive urine test for any recreational drugs other than marijuana at screening (Day -7/-6); Currently on prescription medication that contraindicates use of suvorexant (including moderate or strong Cytochrome P450 3A modulators (CYP3A inhibitors and inducers)); 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; 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); 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; Hepatic insufficiency (AST/ALT > 5x upper limit of normal (ULN)); 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); Use of suvorexant (within 30 days of Day -7); Suicidal Ideation determined by greater than moderate Columbia Suicide Severity Rating Scale.

ClinicalTrials.gov NCT06679062