Evaluating the effects of suvorexant on drug demand in people with opioid use disorder
Measuring Acute Drug Demand in Humans
This study is testing if the sleep medication suvorexant can help people with opioid use disorder reduce their cravings for drugs.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05829655 on ClinicalTrials.gov |
What this trial studies
This research evaluates whether suvorexant, a medication approved for treating insomnia, can reduce the use and demand for various drugs in individuals with opioid use disorder. Participants will undergo a screening visit followed by a 14 to 16 day inpatient stay at Johns Hopkins Bayview Medical Center, where they will be stabilized on hydromorphone. They will be randomly assigned to receive either suvorexant or a placebo and will participate in five experimental sessions involving blinded study medications. The study aims to assess the subjective liking and demand for drugs while on treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who meet the criteria for moderate or severe opioid use disorder.
Not a fit: Patients who are pregnant, breastfeeding, or seeking opioid use treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new approach to reducing drug demand and improving outcomes for patients with opioid use disorder.
How similar studies have performed: While suvorexant is not currently approved for this purpose, similar studies exploring its effects on drug demand are limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 65 years old * Meets Diagnostic and Statistical Manual-5 criteria for Opioid Use Disorder (OUD) (moderate or severe) * Lifetime substance use history criterion \[blinded\] * Medically cleared to take suvorexant and blinded study medications * Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests Exclusion Criteria: * Pregnant or breast feeding * Seeking opioid use treatment * Significant mental health or physical disorder that is expected to interfere with study participation as assessed by the study physicians or medical staff * Known contraindications or allergies to suvorexant and/or the blinded study medications
Where this trial is running
Baltimore, Maryland
- Behavioral Pharmacology Research Unit — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Justin Strickland, PhD — Johns Hopkins University
- Study coordinator: Justin Strickland, PhD
- Email: jstric14@jhmi.edu
- Phone: (410) 550-1975
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.