Opioid Use DisorderEarly Phase 1BED(In)(44)NCT06312657
Behavioral Effects of Drugs Inpatient 44 Neurobehavioral Mechanisms of Opioid Choice
A Early Phase 1 study testing Drug Cue, Money and Withdrawal 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 choice tasks to determine the impact of withdrawal and drug cues on decision-making in individuals with opioid use disorder and physical opioid dependence. 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?
- Drug Cue, Money and Withdrawal
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 28 Mar 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
- Individuals must meet criteria for moderate/severe opioid use disorder, report past month opioid misuse, and be physically dependent on short-acting opioids (e.g., heroin, hydromorphone, fentanyl), as evidenced by either urine sample positive for recent opioid use during each visit or if opioid negative, displaying frank withdrawal during screening.
- History of intravenous opioid use.
- Baseline O2 saturation of 95% or greater.
- Between the ages of 18-50 years.
- 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). Urine pregnancy tests will be conducted prior to sessions to ensure that female subjects do not participate if pregnant.
- Able to speak and read English.
- Otherwise healthy.
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/caffeine that would require detoxification (i.e., alcohol, benzodiazepines or barbiturates). Negative urine/breath samples for these substances, and the absence of withdrawal, will be required during screening.
- 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.
- Poor venous access.
- Regular use of other medications, with the exception of hormone-based contraceptives for female subjects, daily multivitamins or short-term antibiotic prescriptions.
- 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 or currently taking buprenorphine or methadone as the primary opioid of use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behavioral Effects of Drugs Inpatient 44: Neurobehavioral Mechanisms of Opioid Choice
The objective of this protocol is to use probabilistic choice tasks to determine the impact of withdrawal and drug cues on decision-making in individuals with opioid use disorder and physical opioid dependence.
- Conditions
- Opioid Use Disorder
- Being tested
- Drug Cue, Money, Withdrawal, Remifentanil
- 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 CueBehavioural
Individualized drug cues paired with choice options reinforced by $0.25
MoneyBehavioural
Two money values will be tested ($0.25 and $4.00)
WithdrawalDrug
Participants will be maintained on an opioid agonist. Placebo will be substituted to produce mild-to-moderate withdrawal.
RemifentanilDrug
IV remifentanil will be made available as one of the choice options in some sessions.
| Study group | Role | What they receive |
|---|---|---|
| Probabilistic Choice Task | Experimental | Subjects with opioid use disorder complete a probabilistic concurrent choice task under opioid maintained and withdrawn conditions. Three sessions include a money-vs-money task and three sessions include a drug-vs-money task. Monetary reward value is $0.25 or $4.00. Task option visual cues for the money-vs-money versions are colored envelopes or opioid-associated and matched neutral cues. Drug is an active dose of remifentanil. Receives: Behavioral: Drug Cue; Behavioral: Money; Drug: Withdrawal; Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Task Choices
Proportion of high probability choices. Subjects can choose between two options, one of which is rewarded at a higher probability than the other at a ratio of 6:1. The number of trials varied, so a proportion of total trials is reported.
Measured: Tasks will take approximately 45-60 minutes to complete. Participants will complete 6 sessions in which a choice task will be administered.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Mar 2023
- Primary completion28 Mar 2025
- Study completion28 Mar 2025
Why it stopped: Funding ended
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312657
- Sponsor's protocol ID
- 81971
- Other IDs
- R01DA047368
- Acronym
- BED(In)(44)
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2024
- Last updated
- 30 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Effects of Drugs Inpatient 44: Neurobehavioral Mechanisms of Opioid Choice
- ClinicalTrials.gov ID
- NCT06312657
- Acronym / sponsor ID
- BED(In)(44) / 81971
- Conditions
- Opioid Use Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding ended
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Joshua A. Lile, Ph.D.University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Posted 30 Mar 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 choice tasks to determine the impact of withdrawal and drug cues on decision-making in individuals with opioid use disorder and physical opioid dependence.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probabilistic Choice Task | Experimental | Behavioral: Drug Cue, Behavioral: Money, Drug: Withdrawal, Drug: RemifentanilSubjects with opioid use disorder complete a probabilistic concurrent choice task under opioid maintained and withdrawn conditions. Three sessions include a money-vs-money task and three sessions include a drug-vs-money task. Monetary reward value is $0.25 or $4.00. Task option visual cues for the money-vs-money versions are colored envelopes or opioid-associated and matched neutral cues. Drug is an active dose of remifentanil. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Individuals must meet criteria for moderate/severe opioid use disorder, report past month opioid misuse, and be physically dependent on short-acting opioids (e.g., heroin, hydromorphone, fentanyl), as evidenced by either urine sample positive for recent opioid use during each visit or if opioid negative, displaying frank withdrawal during screening.
- History of intravenous opioid use.
- Baseline O2 saturation of 95% or greater.
- Between the ages of 18-50 years.
- 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). Urine pregnancy tests will be conducted prior to sessions to ensure that female subjects do not participate if pregnant.
Key exclusion criteria (8 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/caffeine that would require detoxification (i.e., alcohol, benzodiazepines or barbiturates). Negative urine/breath samples for these substances, and the absence of withdrawal, will be required during screening.
- 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.
- Poor venous access.
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 CueIndividualized drug cues paired with choice options reinforced by $0.25 | Behavioural | Probabilistic Choice Task |
| MoneyTwo money values will be tested ($0.25 and $4.00) | Behavioural | Probabilistic Choice Task |
| WithdrawalParticipants will be maintained on an opioid agonist. Placebo will be substituted to produce mild-to-moderate withdrawal. | Drug | Probabilistic Choice Task |
| RemifentanilIV remifentanil will be made available as one of the choice options in some sessions. | Drug | Probabilistic Choice Task |
Primary outcome
Task Choices
Time frame: Tasks will take approximately 45-60 minutes to complete. Participants will complete 6 sessions in which a choice task will be administered.
Proportion of high probability choices. Subjects can choose between two options, one of which is rewarded at a higher probability than the other at a ratio of 6:1. The number of trials varied, so a proportion of total trials is reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Opioid Use Disorder
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cue, Money and Withdrawal 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 7 inclusion and 8 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: stopped early, as of the sponsor's last update on 30 Mar 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 30 Mar 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?
Task Choices (time frame: Tasks will take approximately 45-60 minutes to complete. Participants will complete 6 sessions in which a choice task will be administered.). 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 30 Mar 2026.