Can a sleep pill boost success in opioid treatment?
NCT ID NCT05145764
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This study tests whether adding the sleep medication suvorexant to standard buprenorphine treatment can improve sleep and medication adherence in people with opioid use disorder who have recently used fentanyl. Participants first stay in a residential setting for five days to start buprenorphine, then continue treatment as outpatients for three weeks. The trial compares suvorexant against a placebo, measuring sleep quality and how consistently participants take their buprenorphine.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- suvorexant
- What this could lead to
- If it works, adding suvorexant to standard buprenorphine treatment could improve sleep and help people stick with their recovery medication, potentially reducing relapse.
- What could go wrong
- This is a small, early-stage trial, so results may not hold up in larger studies. Suvorexant can cause side effects like drowsiness or unusual sleep behaviors, and its benefit for opioid use disorder is unproven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
76 people
The number who actually took part.
- Started
-
Mar 2022
- Finished
-
Aug 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Aged 18-65 * Meets DSM-5 criteria for opioid use disorder (OUD) with evidence of physical dependence on opioids * Provides a urine sample that tests positive for fentanyl and/or fentanyl analogues * Interest in being maintained on buprenorphine for OUD * Plans to reside in current area for study period * Achieving a study maintenance dose of \>=8mg sublingual buprenorphine/naloxone * Willing to comply with study protocol * Have no clinically significant chronic medical or surgical disorders or conditions that are judged by the investigators to prevent participation Exclusion Criteria: * Medically contraindicated for buprenorphine, extended-release (XR)-buprenorphine (Sublocade), or suvorexant (as per medication labels) * Pregnant or breast feeding * Severe Diagnostic and Statistical Manual (DSM)-5 alcohol or benzodiazepine use disorder or evidence of alcohol/benzodiazepine physical dependence * Have a known allergy to the study medications * Past 30-day prescribed use of suvorexant for the indication of insomnia * Current benzodiazepine or other prescribed medication for the indication of insomnia * Urine sample testing positive for benzodiazepine at screening and admission to residential treatment * Current narcolepsy, restless leg syndrome or sleep paralysis * High risk for current sleep apnea * Current (past 30-day) suicidal behaviors * Severe hepatic or renal impairment * aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3x upper limit of normal (ULN) * Total bilirubin \>2x ULN * Creatinine \>1.5x ULN * Past year clinically-significant psychiatric condition judged to interfere with study participation * Lack of access to stable housing (necessary for electronic pill dispenser charging) * Have circumstances that would interfere with study participation (e.g., impending jail)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Opioid-use disorder are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can exercise boost brain and body health during opioid treatment?
- Can a new drug calm the storm of opioid withdrawal?
- Can coaching turn rural clinics into One-Stop shops for addiction and infectious disease care?
- Can a Phone-Based platform keep people in opioid treatment?
- A safety net after jail: can checkups keep opioid treatment on track?
- Can AI and peer support close the opioid treatment gap?