Suvorexant for Insomnia

(SUV Trial)

Recruiting at 1 trial location

Overseen By Lara Ray, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 0

76 Participants Needed

Trial Summary

What is the purpose of 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.

Research Team

Lara Ray, PhD

Principal Investigator

University of California, Los Angeles

Scott Lane, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for men and women aged 21-65, both veterans and non-veterans, who are experiencing symptoms of PTSD along with alcohol use disorder. Participants should be willing to attempt stopping drinking for two weeks and complete daily virtual diaries as well as in-person clinic visits.

Inclusion Criteria

Must have an ISI score equal to or > 7

Intrinsic motivation to reduce or quit drinking and to receive PTSD treatment

Agree to abstain from all other sleep medications

Exclusion Criteria

Current DSM-5 diagnosis of substance use disorder for substances other than alcohol, nicotine, or marijuana

Lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or psychotic disorder

Positive urine test for recreational drugs other than marijuana at screening

Treatment Details

Interventions

• Suvorexant

Trial Overview The study tests if suvorexant (SUV) can help reduce insomnia in participants with PTSD and AUD. After a week on placebo, they're randomly chosen to either continue with the placebo or switch to suvorexant for another two weeks while trying to abstain from alcohol.

Participant Groups

Group I: 10mg and 20mg Suvorexant (SUV) Active Control 1 Intervention

Participants will be randomly assigned to receive SUV (10mg (Days 0-6) and 20mg (Days 7-13)).

Group II: Placebo Placebo Group 1 Intervention

Participants will be randomly assigned to receive matched placebo (Days 0-13).

Suvorexant is already approved in United States, Japan for the following indications:

Approved in United States as Belsomra for:

• Insomnia characterized by difficulties with sleep onset and/or sleep maintenance

Approved in Japan as Belsomra for:

• Insomnia characterized by difficulties with sleep onset and/or sleep maintenance

Who Is Running the Clinical Trial?

Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

Lead Sponsor

Trials

9

Recruited

350+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

The University of Texas Health Science Center, Houston

Collaborator

Trials

974

Recruited

361,000+