Opioid Use Disorder Research Study
Researchers at Johns Hopkins University are conducting a study to determine if a prescription medication to treat insomnia helps sleep problems in individuals with opioid use disorders.
Fast Facts
Ages 18-65
Diagnosed with Opioid Use Disorder and Dependent on Fentanyl/Other Opioids
Compensation Provided
Conducted in Baltimore, MD
Study Background
Evaluating Suvorexant for Sleep Disturbance in Opioid Use Disorders
This study aims to explore whether Suvorexant, a medication commonly used to help with sleep, can improve sleep disturbances in people with opioid use disorder during treatment. Participants will be randomly assigned to either Suvorexant or a placebo for four weeks. The study begins with a five-day residential phase where participants will stabilize on sublingual buprenorphine—a medication used to treat opioid dependence. Before starting buprenorphine, participants will receive hydromorphone (a short-acting opioid) to manage withdrawal symptoms as their bodies clear fentanyl. Suvorexant or placebo treatment will start on the second night and continue throughout the study. By the end of Day 5, participants will be transitioned to a stable buprenorphine dose, adjusted based on their needs, and discharged for outpatient care.
During the outpatient phase, participants will continue on buprenorphine until switching to an extended-release formulation at the end of Week 4. Sleep will be closely monitored throughout the study using wearable devices and sleep-tracking technology. Researchers will also track opioid withdrawal symptoms, cravings, and other health outcomes multiple times daily during the residential phase and through mobile assessments during outpatient care. This study aims to understand whether Suvorexant can improve sleep and overall outcomes during opioid use treatment.
Study Background
Evaluating Suvorexant for Sleep Disturbance in Opioid Use Disorders
This study aims to explore whether Suvorexant, a medication commonly used to help with sleep, can improve sleep disturbances in people with opioid use disorder during treatment. Participants will be randomly assigned to either Suvorexant or a placebo for four weeks. The study begins with a five-day residential phase where participants will stabilize on sublingual buprenorphine—a medication used to treat opioid dependence. Before starting buprenorphine, participants will receive hydromorphone (a short-acting opioid) to manage withdrawal symptoms as their bodies clear fentanyl. Suvorexant or placebo treatment will start on the second night and continue throughout the study. By the end of Day 5, participants will be transitioned to a stable buprenorphine dose, adjusted based on their needs, and discharged for outpatient care.
During the outpatient phase, participants will continue on buprenorphine until switching to an extended-release formulation at the end of Week 4. Sleep will be closely monitored throughout the study using wearable devices and sleep-tracking technology. Researchers will also track opioid withdrawal symptoms, cravings, and other health outcomes multiple times daily during the residential phase and through mobile assessments during outpatient care. This study aims to understand whether Suvorexant can improve sleep and overall outcomes during opioid use treatment.
Additional Information
This study aims to determine if Suvorexant can improve sleep and support recovery in people with opioid use disorder, as sleep disturbances often worsen withdrawal symptoms and cravings during treatment. It seeks to enhance understanding of how better sleep may contribute to improved treatment outcomes.
You may qualify for this study if you meet the following criteria.
Inclusion Criteria:
- Ages 18-65
- Diagnosed with opioid use disorder and dependent on opioids including fentanyl
- Able to take buprenorphine, sublocade, or suvorexant
- Have a stable living situation
Exclusion Criteria:
- Using buprenorphine, suboxone, methadone, or naltrexone as treatment for opioid use
- Severe alcohol, benzodiazepine, or stimulate use disorder
- Taking benzodiazepines or other prescribed medications for insomnia
- Narcolepsy, restless leg syndrome, or sleep paralysis
- Suicidal ideation
- Hepatic or renal impairment
- If female, pregnant or breastfeeding
If you join this study, here’s what you can expect:
Joining and Group Assignment:
You’ll be randomly placed in one of two groups: one taking Suvorexant (a sleep medication) and the other taking a placebo (a pill with no active medicine).
5-Day Stay at the Clinic:
For the first 3 days, you’ll take a short-acting opioid (hydromorphone) to help with withdrawal as your body clears fentanyl.
Starting the second night, you’ll begin taking Suvorexant or the placebo.
By the end of Day 5, you’ll start on a medication called buprenorphine to manage withdrawal symptoms and cravings.
During this time, your sleep will be monitored using sleep trackers, and you’ll be asked about your symptoms and cravings multiple times a day.
Outpatient Care (Weeks 2-4):
After your stay, you’ll continue treatment at home with daily buprenorphine doses.
You’ll wear a sleep tracker at night and answer questions about how you’re feeling using your phone.
End of the Study (Week 4):
At the end of Week 4, you’ll switch to a long-acting version of buprenorphine, and your sleep will be checked again using a special sleep tracker.
This study is designed to see if Suvorexant can help improve sleep and make opioid recovery easier.
Participants can receive up to $1,130 for completion of all parts of this study.
There is no cost for you to participate in our research study.