Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT06643988

Autobiographical Memory in Opioid Use Disorder

Led by University of Pennsylvania · Updated on 2025-08-29

30

Participants Needed

1

Research Sites

40 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The research study is being conducted to better understand memory function in people with opioid use disorder (OUD) and whether memory training can improve the symptoms and lives of people with OUD. Further, this study seeks to identify how brain and heart activity contribute to memory function and OUD symptoms. Participants will be asked to complete a baseline assessment, four weeks of at-home memory training (MemFlex), and a post-treatment follow-up assessment. Everyone enrolled will receive MemFlex as there is no placebo group. Each visit will include collection of a urine sample for drug testing. During the baseline and follow-up assessments, researchers will collect brain information using functional near-infrared spectroscopy (fNIRS) and heartbeat data using a wearable wristband sensor. MemFlex is a cognitive-behavioral intervention that does not pose any risk. However, the use of MemFlex in this study is experimental as it has not been tested in individuals with OUD. We will enroll 20 participants with OUD and 10 participants meeting healthy volunteer criteria.

CONDITIONS

Official Title

Autobiographical Memory in Opioid Use Disorder

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years to 60 years old.
  • Willingness to provide signed, informed consent and commit to completing study procedures.
  • Ability and willingness to comply with scheduled visits, treatment plans, lab tests, and other procedures.
  • Access to a cellphone.
  • Lifetime self-reported history of opioid use disorder according to DSM-5 criteria.
  • Stable dose of medication for opioid use disorder for at least 2 weeks.
  • Access to a stable residence or space to complete at-home treatment.
Not Eligible

You will not qualify if you...

  • Current severe psychiatric or physical disorder that significantly interferes with brain function or safety.
  • Head trauma or injury likely affecting the prefrontal cortex (e.g., extended loss of consciousness, skull fracture, intracranial bleeding).
  • Medical conditions or treatments interfering with ability to complete the intervention.
  • Inability to sit upright, remain still, and operate a mouse and keypad.
  • Participation in another research study or clinical trial with investigational drugs within 30 days.
  • Currently prescribed opioid medications for pain or other disorders besides opioid use disorder.
  • Past 1-year history of non-opioid substance use disorder, except nicotine, alcohol, or cannabis.
  • Positive urine drug screen for substances other than opioids, cocaine, or cannabis at screening or baseline.
  • For healthy volunteers: lifetime history of substance use disorders (except nicotine use disorder anytime and remote alcohol or cannabis use disorders).
  • For healthy volunteers: positive urine drug screen at screening or baseline.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

M

Megan Ivey, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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