Opioid Use DisorderEarly Phase 1NCT05829655
Measuring Acute Drug Demand in Humans
A Early Phase 1 study testing Drug A (Blinded Drug), Drug B (Blinded Drug) and Drug C (Blinded Drug) in people with Opioid Use Disorder and Opioid Dependence, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder, Opioid Dependence
- What is being tested?
- Drug A (Blinded Drug), Drug B (Blinded Drug) and Drug C (Blinded Drug)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2023to 1 Jan 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
General Clinical Research Center
Baltimore, Maryland, 21201
Justin Strickland, PhD, 667-354-3516, jstrickland@som.umaryland.edu
Justin Strickland, PhD
About this study
This research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs.
Read the detailed description
This research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs. Suvorexant is not approved as a treatment to reduce drug use but is approved by the Food and Drug Administration (FDA) to treat insomnia (trouble falling asleep or staying asleep). This study consists of a screening visit and an approximate 14 to 16 day inpatient (overnight) stay at the University of Maryland, Baltimore. Participants will be stabilized on hydromorphone, randomly assigned to receive either suvorexant or placebo, and complete 5 experimental sessions that include taking blinded study medications.
- Conditions
- Opioid Use Disorder, Opioid Dependence
- Being tested
- Drug A (Blinded Drug), Drug B (Blinded Drug), Drug C (Blinded Drug), Drug D (Blinded Drug), Suvorexant (20mg/day)
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug A (Blinded Drug)Drug
Participants will receive a double-blinded oral study medication as part of their daily sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, they are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study).
Drug B (Blinded Drug)Drug
Participants will receive a double-blinded oral study medication as part of their daily sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, they are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study).
Drug C (Blinded Drug)Drug
Participants will receive a double-blinded oral study medication as part of their daily sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, they are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study).
Drug D (Blinded Drug)Drug
Participants will receive a double-blinded oral study medication as part of their daily sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, they are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study).
Suvorexant (20mg/day)Drug
Double blind administration of suvorexant once per day during residential stay until discharge.
PlaceboDrug
Double blind administration of placebo once per day during residential stay until discharge.
| Study group | Role | What they receive |
|---|---|---|
| Suvorexant (20mg/day) | Experimental | Double blind administration of suvorexant once per day during residential stay until discharge Receives: Drug: Drug A (Blinded Drug); Drug: Drug B (Blinded Drug); Drug: Drug C (Blinded Drug); Drug: Drug D (Blinded Drug); Drug: Suvorexant (20mg/day) |
| Placebo | Placebo comparator | Double blind administration of placebo once per day during residential stay until discharge Receives: Drug: Drug A (Blinded Drug); Drug: Drug B (Blinded Drug); Drug: Drug C (Blinded Drug); Drug: Drug D (Blinded Drug); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demand Intensity
Consumption of blinded drug at unconstrained price as measured by an incentivized demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate more drug consumption at unconstrained price (a worse outcome).
Measured: Upon completion of experimental session (~8 hours post drug administration)
Demand Elasticity
Changes in blinded drug consumption with changes in price as measured by an incentivized demand task. There is no minimum or maximum value. Higher scores indicate greater drug price sensitivity (a better outcome).
Measured: Upon completion of experimental session (~8 hours post drug administration)
Cross-Price Elasticity
Change in consumption of price-fixed good based on change in price of price varying good. Positive values indicate a substitute, negative values indicate a complement, and zero values indicate an independent commodity.
Measured: After Experimental Session 4
Secondary outcomes (1)
Total Mean Sleep Time
Mean total number of minutes slept per night as measured by actigraphy and self-reported sleep diary. Mean total sleep time will be collected daily.
Measured: Through study completion, up to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start8 Aug 2023
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Justin Strickland, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829655
- Sponsor's protocol ID
- HP-00116510
- Other IDs
- R01DA055634
- Status last verified
- Jun 2026
- First submitted
- 13 Apr 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Acute Drug Demand in Humans
- ClinicalTrials.gov ID
- NCT05829655
- Acronym / sponsor ID
- HP-00116510
- Conditions
- Opioid Use Disorder, Opioid Dependence
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs.
Detailed description
This research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs. Suvorexant is not approved as a treatment to reduce drug use but is approved by the Food and Drug Administration (FDA) to treat insomnia (trouble falling asleep or staying asleep). This study consists of a screening visit and an approximate 14 to 16 day inpatient (overnight) stay at the University of Maryland, Baltimore. Participants will be stabilized on hydromorphone, randomly assigned to receive either suvorexant or placebo, and complete 5 experimental sessions that include taking blinded study medications.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suvorexant (20mg/day) | Experimental | Drug: Drug A (Blinded Drug), Drug: Drug B (Blinded Drug), Drug: Drug C (Blinded Drug), Drug: Drug D (Blinded Drug), Drug: Suvorexant (20mg/day)Double blind administration of suvorexant once per day during residential stay until discharge |
| Placebo | Placebo comparator | Drug: Drug A (Blinded Drug), Drug: Drug B (Blinded Drug), Drug: Drug C (Blinded Drug), Drug: Drug D (Blinded Drug), Drug: PlaceboDouble blind administration of placebo once per day during residential stay until discharge |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug A (Blinded Drug)Participants will receive a double-blinded oral study medication as part of their daily sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, they are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study). | Drug | Placebo, Suvorexant (20mg/day) |
| Drug B (Blinded Drug)Participants will receive a double-blinded oral study medication as part of their daily sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, they are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study). | Drug | Placebo, Suvorexant (20mg/day) |
| Drug C (Blinded Drug)Participants will receive a double-blinded oral study medication as part of their daily sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, they are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study). | Drug | Placebo, Suvorexant (20mg/day) |
| Drug D (Blinded Drug)Participants will receive a double-blinded oral study medication as part of their daily sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, they are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study). | Drug | Placebo, Suvorexant (20mg/day) |
| Suvorexant (20mg/day)Double blind administration of suvorexant once per day during residential stay until discharge. | Drug | Suvorexant (20mg/day) |
| PlaceboDouble blind administration of placebo once per day during residential stay until discharge. | Drug | Placebo |
Primary outcome
Demand Intensity
Time frame: Upon completion of experimental session (~8 hours post drug administration)
Consumption of blinded drug at unconstrained price as measured by an incentivized demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate more drug consumption at unconstrained price (a worse outcome).
Demand Elasticity
Time frame: Upon completion of experimental session (~8 hours post drug administration)
Changes in blinded drug consumption with changes in price as measured by an incentivized demand task. There is no minimum or maximum value. Higher scores indicate greater drug price sensitivity (a better outcome).
Cross-Price Elasticity
Time frame: After Experimental Session 4
Change in consumption of price-fixed good based on change in price of price varying good. Positive values indicate a substitute, negative values indicate a complement, and zero values indicate an independent commodity.
1 secondary outcome
Total Mean Sleep Time
Time frame: Through study completion, up to two weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Justin Strickland, PhD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Drug A (Blinded Drug), Drug B (Blinded Drug) and Drug C (Blinded Drug) in people with Opioid Use Disorder and Opioid Dependence, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justin Strickland, PhD (667-354-3516, jstrickland@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demand Intensity (time frame: Upon completion of experimental session (~8 hours post drug administration)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.