Opioid Use DisorderEarly Phase 1NCT03958474
Neurobehavioral Mechanisms of Choice in Opioid Use Disorder
A Early Phase 1 study testing Oxycodone in people with Opioid Use Disorder, run by Joshua A. Lile, Ph.D. at 1 site in United States.
Trial summary
The objective of this protocol is to use probabilistic reinforcement learning choice tasks and magnetic resonance neuroimaging to demonstrate the impact of problematic opioid use and opioid withdrawal on dynamic decision-making and reveal the neurobehavioral and neurobiological processes underlying abnormal task… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2019to 10 Jul 2025
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must meet moderate/severe criteria for moderate/severe opioid use disorder, report recent prescription or illicit opioid use, and be opioid dependent, as evidenced by either a urine sample positive for recent opioid use or being in frank withdrawal during screening.
- Female subjects must be using an effective form of birth control (e.g., birth control pills, surgical sterilization, IUD, cervical cap with a spermicide, or abstinence).
- Able to speak and read English
- Subjects who are interested in completing the remifentanil dose-ranging session must report a history of intravenous opioid use and a baseline O2 saturation of 95% or greater.
Who cannot join
- History of, or current, clinically significant physical disease (e.g., respiratory disease [asthma, COPD, sleep apnea], impaired cardiovascular functioning, seizure disorder or CNS tumors) or current or past history of psychiatric disorder that would limit compliance in the studies, other than substance use disorder.
- Meet diagnostic criteria for psychoactive substance use disorder for substances other than opioids (OUD subjects only) or nicotine that would require detoxification (i.e., alcohol, benzodiazepines or barbiturates).
- Contraindications for MRI scanning (e.g., pacemaker, metal implants, claustrophobia, or any other implanted medical device).
- Vision or hearing problems that would preclude completion of experimental tasks.
- At risk for respiratory complications and have predictors of difficult bag mask ventilation (e.g., dentures, very full beard), in case emergency respiratory intervention is needed.
- Seeking treatment for SUD.
- Poor venous access (only subjects who will participate in the remifentanil dose-ranging session).
Trial locations and contacts
1 site in 1 country.
United States1 site
Laboratory of Human Behavioral Pharmacology
Lexington, Kentucky, 40536-0086
About this study
The objective of this protocol is to use probabilistic reinforcement learning choice tasks and magnetic resonance neuroimaging to demonstrate the impact of problematic opioid use and opioid withdrawal on dynamic decision-making and reveal the neurobehavioral and neurobiological processes underlying abnormal task performance. A second objective is to identify an appropriate dose of intravenous remifentanil for subsequent studies in physically dependent individuals with opioid use disorder.
- Conditions
- Opioid Use Disorder
- Being tested
- Oxycodone
- 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.
OxycodoneDrug
Participants receive oxycodone or placebo.
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone | Experimental | Subjects complete a probabilistic money-vs-money choice task during oxycodone maintenance. Receives: Drug: Oxycodone |
| Withdrawal | Experimental | Subjects complete a probabilistic money-vs-money choice task during opioid withdrawal induced via double-blind substitution of placebo for active oxycodone in maintenance capsules. Receives: Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probabilistic Money vs Money Choice Task
Subjects completed a 300-trial probabilistic concurrent monetary choice task, also known as an n-bandit task (here, n=2 choice options, with unsigned probability reversals every 50 trials). In each trial, subjects chose between two options signaled by blue and green envelopes. When a reward was scheduled for the chosen option, subjects were notified they earned $0.25 USD; task earnings were provided upon session completion. Choice of the high probability option was more likely to be reinforced than the low probability option at a 6:1 ratio, with probabilities summing to 0.3, resulting in a low reinforcement density context. Because choosing the higher probability option is associated with a higher likelihood of receiving a monetary reinforcer, making more high probability choices is considered better performance on the task.
Measured: Subjects complete the task twice; once under opioid maintained and once under opioid withdrawn conditions during a 16-day inpatient participation. The task takes approximately 20 minutes to complete each time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start16 Aug 2019
- Primary completion10 Jul 2025
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- Within-subjects design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joshua A. Lile, Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Joshua A. Lile, Ph.D., University of Kentucky
- Investigators
- JOSHUA LILE, Ph.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958474
- Sponsor's protocol ID
- 47844
- Other IDs
- R01DA047368
- Status last verified
- Jul 2026
- First submitted
- 16 May 2019
- Last updated
- 2 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shellenberg TP, Baidwan T, Johansen AN, Strickland JC, Martinez S, Regnier SD, Wesley MJ, Babalonis SL, Stoops WW, Lile JA. Effects of simulated and real opioid withdrawal on delay discounting for opioids and money in people who use fentanyl daily. Exp Clin Psychopharmacol. 2026 Sep 28:10.1037/pha0000878. doi: 10.1037/pha0000878. Online ahead of print.
PubMed 42804230
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobehavioral Mechanisms of Choice in Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT03958474
- Acronym / sponsor ID
- 47844
- Conditions
- Opioid Use Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Joshua A. Lile, Ph.D.University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 16 Aug 2019 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Posted 2 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this protocol is to use probabilistic reinforcement learning choice tasks and magnetic resonance neuroimaging to demonstrate the impact of problematic opioid use and opioid withdrawal on dynamic decision-making and reveal the neurobehavioral and neurobiological processes underlying abnormal task performance. A second objective is to identify an appropriate dose of intravenous remifentanil for subsequent studies in physically dependent individuals with opioid use disorder.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Within-subjects design
| Arm | Type | Receives |
|---|---|---|
| Oxycodone | Experimental | Drug: OxycodoneSubjects complete a probabilistic money-vs-money choice task during oxycodone maintenance. |
| Withdrawal | Experimental | Drug: OxycodoneSubjects complete a probabilistic money-vs-money choice task during opioid withdrawal induced via double-blind substitution of placebo for active oxycodone in maintenance capsules. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Must meet moderate/severe criteria for moderate/severe opioid use disorder, report recent prescription or illicit opioid use, and be opioid dependent, as evidenced by either a urine sample positive for recent opioid use or being in frank withdrawal during screening.
- Female subjects must be using an effective form of birth control (e.g., birth control pills, surgical sterilization, IUD, cervical cap with a spermicide, or abstinence).
- Able to speak and read English
- Subjects who are interested in completing the remifentanil dose-ranging session must report a history of intravenous opioid use and a baseline O2 saturation of 95% or greater.
Key exclusion criteria (7 listed)
- History of, or current, clinically significant physical disease (e.g., respiratory disease [asthma, COPD, sleep apnea], impaired cardiovascular functioning, seizure disorder or CNS tumors) or current or past history of psychiatric disorder that would limit compliance in the studies, other than substance use disorder.
- Meet diagnostic criteria for psychoactive substance use disorder for substances other than opioids (OUD subjects only) or nicotine that would require detoxification (i.e., alcohol, benzodiazepines or barbiturates).
- Contraindications for MRI scanning (e.g., pacemaker, metal implants, claustrophobia, or any other implanted medical device).
- Vision or hearing problems that would preclude completion of experimental tasks.
- At risk for respiratory complications and have predictors of difficult bag mask ventilation (e.g., dentures, very full beard), in case emergency respiratory intervention is needed.
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 |
|---|---|---|
| OxycodoneParticipants receive oxycodone or placebo. | Drug | Oxycodone, Withdrawal |
Primary outcome
Probabilistic Money vs Money Choice Task
Time frame: Subjects complete the task twice; once under opioid maintained and once under opioid withdrawn conditions during a 16-day inpatient participation. The task takes approximately 20 minutes to complete each time.
Subjects completed a 300-trial probabilistic concurrent monetary choice task, also known as an n-bandit task (here, n=2 choice options, with unsigned probability reversals every 50 trials). In each trial, subjects chose between two options signaled by blue and green envelopes. When a reward was scheduled for the chosen option, subjects were notified they earned $0.25 USD; task earnings were provided upon session completion. Choice of the high probability option was more likely to be reinforced than the low probability option at a 6:1 ratio, with probabilities summing to 0.3, resulting in a low reinforcement density context. Because choosing the higher probability option is associated with a higher likelihood of receiving a monetary reinforcer, making more high probability choices is considered better performance on the task.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42804230Shellenberg TP, Baidwan T, Johansen AN, Strickland JC, Martinez S, Regnier SD, Wesley MJ, Babalonis SL, Stoops WW, Lile JA. Effects of simulated and real opioid withdrawal on delay discounting for opioids and money in people who use fentanyl daily. Exp Clin Psychopharmacol. 2026 Sep 28:10.1037/pha0000878. doi: 10.1037/pha0000878. Online ahead of print.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
JOSHUA LILE, Ph.D. principal investigator
University of Kentucky
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 Oxycodone in people with Opioid Use Disorder, run by Joshua A. Lile, Ph.D. 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 2 Jul 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. 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?
Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probabilistic Money vs Money Choice Task (time frame: Subjects complete the task twice; once under opioid maintained and once under opioid withdrawn conditions during a 16-day inpatient participation. The task takes approximately 20 minutes to complete each time.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03958474, which also lists 1 linked publication.
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 2 Jul 2026.