Autobiographical Memory in Opioid Use Disorder

Launched by UNIVERSITY OF PENNSYLVANIA · Oct 14, 2024

Keywords

ClinConnect Summary

This clinical trial is aimed at understanding how memory works in people with opioid use disorder (OUD) and whether memory training can help improve their symptoms and quality of life. Participants in the study will take part in an at-home memory training program called MemFlex for four weeks, and everyone enrolled will receive this training. Researchers will also gather information about brain and heart activity to see how these may relate to memory function and OUD symptoms. The study will involve assessments before and after the training, including urine tests for drug screening.

To be eligible for this study, participants need to be between 18 and 60 years old and have a history of opioid use disorder. They must be stable on their current medication for at least two weeks and have a place to complete the at-home training. Participants will need to provide informed consent and be able to attend study visits. It’s important to note that the MemFlex training is experimental, meaning it hasn't been tested in people with OUD before, but it’s considered safe. If you or someone you know is interested in participating, they should be aware that specific health conditions or recent drug use may affect eligibility.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 years to 60 years old.
• • 2. Willingness to provide signed, informed consent and commit to completing study procedures
• • 3. Subjects must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures, and must have access to a cellphone.
• • 4. OUD subjects: Lifetime self-reported history of OUD (according to DSM-5 criteria)
• • 5. OUD subjects: On a stable dose (at least 2 weeks without change) of MOUD (e.g., buprenorphine, methadone) as confirmed by self-report, urine drug screening, and/or the Prescription Drug Monitoring Program database.
• • 6. OUD subjects: Access to a stable residence or space to complete the at-home treatment module
• Exclusion Criteria:
• • 1. Current severe psychiatric (e.g., bipolar disorder) or physical (e.g., dementia, Parkinson's disease) determined by self-reported history or physical exam and disorder deemed by PI to significantly interfere with brain function or make the study hazardous for the subject.
• • 2. Head trauma or injury deemed by PI as likely to impact the prefrontal cortex (e.g., loss of consciousness for more than 30 minutes or skull fracture, intracranial bleeding, or abnormal MRI) as determined by self-reported history or physical exam.
• • 3. Medical condition or medical treatment that may interfere with the subject's ability to complete the intervention, at discretion of the PI (e.g., extended surgery planned or expecting to give birth during the course of the study)
• • 4. Inability to sit upright while remaining relatively still and operating a mouse and keypad.
• • 5. Current ongoing participation in a research study or participation in a clinical trial and receipt of investigational drug(s) or intervention during 30 days prior to the research study, except as explicitly approved by the Principal Investigator.
• • 6. Currently prescribed opioid medication for treatment of pain or other disorder (besides opioid use disorder).
• • 7. OUD subjects: Past 1-year history of non-OUD substance use disorder (other than nicotine, alcohol, or cannabis use disorders).
• • 8. OUD subjects: Positive urine drug screen for any tested substances except for opioids, cocaine, and cannabis at screening or the baseline assessment visit (a test may be repeated if it is needed to confirm accuracy).
• • 9. HC subjects: Lifetime history of any substance use disorder (other than nicotine use disorder at any time and alcohol or cannabis use disorders more than 1 year ago).
• • 10. HC subjects: Positive urine drug screen for any tested substances at screening or the baseline assessment visit (a test may be repeated if it is needed to confirm accuracy).