Autobiographical memory in people with opioid use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants complete a baseline visit with brain (fNIRS) and heart-rate monitoring and urine drug testing, then do four weeks of self-led MemFlex memory training at home, followed by a post-treatment follow-up visit with the same physiological and urine measurements. Everyone enrolled receives the MemFlex intervention (no placebo arm). The protocol targets autobiographical memory processes thought to support emotion regulation and goal-directed behavior, and will explore how brain and cardiac signals relate to memory and OUD symptoms. Enrollment focuses on adults on a stable dose of medication for opioid use disorder who can complete at-home modules and attend in-person assessments at the University of Pennsylvania.

Why it matters

Who can join: the full rules

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).

Where it's running

• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Megan Ivey, MS
• Email: megan.ivey@pennmedicine.upenn.edu
• Phone: 215-746-7712

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.