Project SUVO

Study Information

Project SUVO is a research study funded by the National Institute on Drug Abuse (NIDA) and sponsored by Merck, Sharp, and Dohme, LLC. We are testing whether the medication Suvorexant (also known as Belsomra) can improve sleep in individuals diagnosed with opioid use disorder who experience insomnia (trouble falling asleep or staying asleep). Participation in Project SUVO would involve up to 7 visits to Butler Hospital in Providence, RI, 3 visits to Kent Hospital in Warwick, RI, and one exit interview via telephone. These visits will take place over a 16-week period.

Compensation/Reimbursement

Participants will receive up to $1,555 for completing all assessments.

More Information/FAQ

Who is eligible for the study?
Participants must be between 18 and 70 years old, who are currently experiencing insomnia and have been taking medication for opioid use disorder (e.g., Buprenorphine or Methadone) for 3 or more weeks to be considered for the study.

How much time is involved?
To determine eligibility, you will first complete a 30-minute screening interview. If you appear to meet study criteria, you will then complete the following:

• A 3-hour intake appointment including interviews, questionnaires, an ECG, and a blood draw.
• Three overnight polysomnography (PSG/sleep study) sessions at Kent Hospital.
• Up to 6 additional in-person visits at Butler Hospital for study assessments and medication disbursement.
• A brief telephone call with a study doctor at the end of your participation.

What happens during the study visits?
During the baseline intake assessment, you will complete a series of questionnaires and interviews with research staff. You will also have an electrocardiogram (ECG) to record your heart activity. This involves a trained technician placing small sticky electrodes on your chest and abdomen. A blood draw will also be done at this appointment.

A computer will randomly assign you to receive either suvorexant or a placebo pill. A placebo is an inactive substance that looks like the study drug but contains no active drug. You will be asked to take your assigned medication daily at the same time before bed, as well as keep a sleep diary, for 10 weeks. During these 10 weeks, you will complete 3 overnight sleep studies at a sleep lab (PSG facility). The PSG will measure your brain activity and record eye and chin movements while your sleep. You will visit Butler Hospital up to 6 times to receive study medication and complete assessments. Two weeks after you stop taking the study medication, a study doctor will contact you by phone to check-in.

What is the medication, Suvorexant?
Suvorexant, also known as Belsomra, is a prescription medication approved by the FDA to help adults with insomnia, a sleep disorder where it is hard to fall or stay asleep. It works by blocking brain chemicals called orexins, which normally keep you awake and alert. By blocking orexins, suvorexant makes it easier to fall asleep and stay asleep.

What is the goal is this study?
The goal of Project SUVO is to determine if suvorexant is a safe and effective treatment for people with insomnia who are in opioid recovery, by comparing it to a placebo. We will compare your sleep study (PSG data) from before starting the medication to the PSG data collected after stopping the medication to see if there are any differences.

Is transportation provided?
We may be able to provide transportation, depending on where you live. Please inquire with our study staff to see if you qualify!

If you’re interested in participating, complete the contact submission form above or call the research team at (401) 793-0914. You will be asked a series of questions to determine if you meet criteria for eligibility. If eligible, research staff will arrange your study appointment.