Suvorexant for Treatment of AUD and PTSD

Launched by PHARMACOTHERAPIES FOR ALCOHOL AND SUBSTANCE USE DISORDERS ALLIANCE · Nov 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called suvorexant to see if it can help reduce insomnia in adults aged 21 to 65 who have symptoms of Post-Traumatic Stress Disorder (PTSD) and Alcohol Use Disorder (AUD). The study will include 76 participants, both veterans and non-veterans. Before starting the trial, everyone will go through a week-long period without the medication to see how they feel. After that, they will be randomly assigned to receive either the medication or a placebo (a non-active treatment) for 14 days. During this time, participants will try to stop drinking alcohol and will keep daily journals about their experiences. They will also visit the clinic in person on two occasions for follow-up assessments.

To be eligible for this trial, participants must be between 21 and 65 years old, currently experiencing symptoms of PTSD, and have a moderate to severe alcohol use problem. They should be motivated to reduce or quit drinking and must have some trouble sleeping. However, individuals with certain serious mental health conditions, ongoing substance use issues (other than alcohol), or specific medical conditions may not qualify for the trial. It's important to note that this study has not started recruiting participants yet, so there will be no immediate enrollment. If you or someone you know is interested, please stay tuned for more information as the trial progresses.

Gender

ALL

Eligibility criteria

• 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.