Behavioral Effects of Drugs Inpatient 44 Neurobehavioral Mechanisms of Opioid Choice (NCT06312657) | Clinical Trial Compass
TerminatedEarly Phase 1
Behavioral Effects of Drugs Inpatient 44 Neurobehavioral Mechanisms of Opioid Choice
Stopped: Funding ended
United States2 participantsStarted 2023-03-01
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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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…
What they're measuring
1
Task Choices
Timeframe: Tasks will take approximately 45-60 minutes to complete. Participants will complete 6 sessions in which a choice task will be administered.