Trial Outcomes & Findings for Behavioral Effects of Drugs Inpatient 44 Neurobehavioral Mechanisms of Opioid Choice (NCT NCT06312657)
NCT ID: NCT06312657
Last Updated: 2026-03-30
Results Overview
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.
Recruitment status
TERMINATED
Study phase
EARLY_PHASE1
Target enrollment
2 participants
Primary outcome timeframe
Tasks will take approximately 45-60 minutes to complete. Participants will complete 6 sessions in which a choice task will be administered.
Results posted on
2026-03-30
Participant Flow
Participant milestones
| Measure |
Probabilistic Choice Task
Subjects with opioid use disorder complete a probabilistic concurrent choice task under opioid maintained and withdrawn conditions.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.
|
|---|---|
|
Money-vs-money Opioid Maintained
STARTED
|
2
|
|
Money-vs-money Opioid Maintained
COMPLETED
|
2
|
|
Money-vs-money Opioid Maintained
NOT COMPLETED
|
0
|
|
Money-vs-money Opioid Withdrawn
STARTED
|
2
|
|
Money-vs-money Opioid Withdrawn
COMPLETED
|
2
|
|
Money-vs-money Opioid Withdrawn
NOT COMPLETED
|
0
|
|
Money-vs-money Maintained Drug Cues
STARTED
|
2
|
|
Money-vs-money Maintained Drug Cues
COMPLETED
|
2
|
|
Money-vs-money Maintained Drug Cues
NOT COMPLETED
|
0
|
|
Drug-vs-low Money Opioid Maintained
STARTED
|
2
|
|
Drug-vs-low Money Opioid Maintained
COMPLETED
|
2
|
|
Drug-vs-low Money Opioid Maintained
NOT COMPLETED
|
0
|
|
Drug-vs-low Money Opioid Withdrawn
STARTED
|
2
|
|
Drug-vs-low Money Opioid Withdrawn
COMPLETED
|
2
|
|
Drug-vs-low Money Opioid Withdrawn
NOT COMPLETED
|
0
|
|
Drug-vs-large Money Opioid Maintained
STARTED
|
2
|
|
Drug-vs-large Money Opioid Maintained
COMPLETED
|
2
|
|
Drug-vs-large Money Opioid Maintained
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Behavioral Effects of Drugs Inpatient 44 Neurobehavioral Mechanisms of Opioid Choice
Baseline characteristics by cohort
| Measure |
Probabilistic Choice Task
n=2 Participants
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.
Drug Cue: Individualized drug cues paired with choice options reinforced by $0.25
Money: Two money values will be tested ($0.25 and $4.00)
Withdrawal: Participants will be maintained on an opioid agonist. Placebo will be substituted to produce mild-to-moderate withdrawal.
Remifentanil: IV remifentanil will be made available as one of the choice options in some sessions.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 5.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Probabilistic Choice Task
n=2 Participants
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.
|
|---|---|
|
Task Choices
drug-vs-money $4.00 opioid maintained
|
0.49 proportion of high probability choices
Standard Deviation 0.02
|
|
Task Choices
money-vs-money $0.25 opioid maintained
|
0.67 proportion of high probability choices
Standard Deviation 0.05
|
|
Task Choices
money-vs-money $0.25 opioid withdrawn
|
0.72 proportion of high probability choices
Standard Deviation 0.00
|
|
Task Choices
money-vs-money $0.25 drug cued opioid maintained
|
0.49 proportion of high probability choices
Standard Deviation 0.02
|
|
Task Choices
drug-vs-money $0.25 opioid maintained
|
0.54 proportion of high probability choices
Standard Deviation 0.13
|
|
Task Choices
drug-vs-money $0.25 withdrawn
|
0.5 proportion of high probability choices
Standard Deviation 0.01
|
Adverse Events
Neutral Cued Money-vs-Money Task Opioid Maintained
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Neutral Cued Money-vs-Money Task Opioid Withdrawn
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Opioid Cued Money-vs-Money Task Opioid Maintained
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Drug-vs-Low Money Task Opioid Maintained
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Drug-vs-High Money Task Opioid Maintained
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Drug-vs-Low Money Task Opioid Withdrawn
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Neutral Cued Money-vs-Money Task Opioid Maintained
n=2 participants at risk
Subjects with opioid use disorder complete a probabilistic concurrent choice task. This session used a money-vs-money task. Monetary reward value is $0.25. Visual cues for the task are colored envelopes. Subjects are maintained on active hydromorphone.
|
Neutral Cued Money-vs-Money Task Opioid Withdrawn
n=2 participants at risk
Subjects with opioid use disorder complete a probabilistic concurrent choice task. This session used a money-vs-money task. Monetary reward value is $0.25. Visual cues for the task are colored envelopes. Subjects experience mild-to-moderate withdrawal associated with double-blind substitution of placebo for active hydromorphone maintenance capsules.
|
Opioid Cued Money-vs-Money Task Opioid Maintained
n=2 participants at risk
Subjects with opioid use disorder complete a probabilistic concurrent choice task. This session used a money-vs-money task. Monetary reward value is $0.25. Visual cues for the task are images of opioid drug and paraphernalia and matched neutral images. Subjects are maintained on active hydromorphone.
|
Drug-vs-Low Money Task Opioid Maintained
n=2 participants at risk
Subjects with opioid use disorder complete a probabilistic concurrent choice task. This session used a drug-vs-money task. Monetary reward value is $0.25. Subjects are maintained on active hydromorphone. The drug option is active remifentanil.
|
Drug-vs-High Money Task Opioid Maintained
n=2 participants at risk
Subjects with opioid use disorder complete a probabilistic concurrent choice task. This session used a drug-vs-money task. Monetary reward value is $4.00. Subjects are maintained on active hydromorphone. The drug option is active remifentanil.
|
Drug-vs-Low Money Task Opioid Withdrawn
n=2 participants at risk
Subjects with opioid use disorder complete a probabilistic concurrent choice task. This session used a drug-vs-money task. Monetary reward value is $0.25. The drug option is active remifentanil. Subjects experience mild-to-moderate withdrawal associated with double-blind substitution of placebo for active hydromorphone maintenance capsules.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Elevated heart rate (>100 bpm)
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
|
Musculoskeletal and connective tissue disorders
Restlessness
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
|
Eye disorders
Pupil dilation
|
100.0%
2/2 • Throughout the 17-day inpatient protocol duration.
|
100.0%
2/2 • Throughout the 17-day inpatient protocol duration.
|
100.0%
2/2 • Throughout the 17-day inpatient protocol duration.
|
100.0%
2/2 • Throughout the 17-day inpatient protocol duration.
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
100.0%
2/2 • Throughout the 17-day inpatient protocol duration.
|
|
Eye disorders
Lacrimation
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
|
Respiratory, thoracic and mediastinal disorders
Runny nose
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
|
Gastrointestinal disorders
Stomach cramps
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
|
Musculoskeletal and connective tissue disorders
Tremor
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
|
Psychiatric disorders
Anxiety or Irritability
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
100.0%
2/2 • Throughout the 17-day inpatient protocol duration.
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
|
Respiratory, thoracic and mediastinal disorders
Respiration rate low
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
100.0%
2/2 • Throughout the 17-day inpatient protocol duration.
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
|
Blood and lymphatic system disorders
oxygen saturation low
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
|
Cardiac disorders
blood pressure out of range
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
100.0%
2/2 • Throughout the 17-day inpatient protocol duration.
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
|
Cardiac disorders
heart rate out of range
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
|
Skin and subcutaneous tissue disorders
Irritation at catheter site
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
|
Blood and lymphatic system disorders
Superficial thrombus
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
|
Respiratory, thoracic and mediastinal disorders
End Tidal CO2 out of range
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
50.0%
1/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
0.00%
0/2 • Throughout the 17-day inpatient protocol duration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place