Suvorexant for Treatment of AUD and PTSD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-65
SponsorPharmacotherapies for Alcohol and Substance Use Disorders Alliance
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Suvorexant
- Placebo
Treatment groups
76 Participants
are divided into 2 treatment groupsSponsors and collaborators
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Lead sponsor
University of California, Los Angeles
Collaborator
The University of Texas Health Science Center, Houston
Collaborator
Source ClinicalTrials.gov