Opioid Use Disorder
Conditions
Brief 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.
Interventions
BEHAVIORALDrug Cue
Individualized drug cues paired with choice options reinforced by $0.25
BEHAVIORALMoney
Two money values will be tested ($0.25 and $4.00)
DRUGWithdrawal
Participants will be maintained on an opioid agonist. Placebo will be substituted to produce mild-to-moderate withdrawal.
DRUGRemifentanil
IV remifentanil will be made available as one of the choice options in some sessions.
Sponsors
Joshua A. Lile, Ph.D.
National Institute on Drug Abuse (NIDA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Task Choices | 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. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 37 years STANDARD_DEVIATION 5.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 | 0 / 2 | 0 / 2 | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 2 / 2 | 2 / 2 | 2 / 2 | 2 / 2 | 1 / 2 | 2 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 | 0 / 2 | 0 / 2 | 0 / 2 | 0 / 2 |
Outcome results
None listed