MemFlex for Opioid Use Disorder

(NAMO Trial)

Overseen By Megan Ivey, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must be taking: MOUD

Must not be taking: Opioid pain medication

Disqualifiers: Severe psychiatric, Head trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how memory training affects individuals with opioid use disorder (OUD). Researchers aim to determine if a memory training program, called MemFlex, can improve symptoms and daily life for those with OUD. The study also examines brain and heart activity to understand their role in memory and OUD symptoms. Individuals diagnosed with OUD and on a stable medication plan might be suitable for this study. Participants will perform memory exercises at home and have their brain and heart monitored during visits. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance treatment for OUD.

Do I need to stop my current medications to join the trial?

The trial does not specify that you need to stop taking your current medications. However, if you are on a stable dose of medication for opioid use disorder (like buprenorphine or methadone), you can continue taking it. If you are currently prescribed opioid medication for pain or other disorders, you cannot participate in the trial.

What prior data suggests that MemFlex is safe for individuals with opioid use disorder?

Research shows that MemFlex is a program using exercises to change thought patterns. Previous studies have generally found methods like MemFlex to be safe and well-received. MemFlex is neither a drug nor a device, so it carries no specific risks. It is important to note that MemFlex has not been tested in individuals with opioid use disorder (OUD) before. However, since it does not involve medication or equipment, there are no known physical risks. Participants in this study will perform memory exercises, which are safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MemFlex for opioid use disorder (OUD) because it offers a new approach by focusing on cognitive training exercises, specifically memory flexibility training. Unlike traditional treatments like methadone or buprenorphine, which rely on medication to manage withdrawal and cravings, MemFlex targets the brain's cognitive processes to potentially improve treatment outcomes. This novel method aims to enhance the brain's ability to adapt and change, which could lead to better long-term recovery and reduced relapse rates for individuals with OUD.

What evidence suggests that MemFlex might be an effective treatment for opioid use disorder?

This trial will compare participants with opioid use disorder (OUD) who receive MemFlex training to healthy controls who do not. Research shows that MemFlex is a therapy designed to improve memory flexibility. This method may enhance brain function, potentially benefiting individuals with OUD. Although MemFlex has not been specifically tested on people with OUD, its principles have shown promise in addressing memory issues in other contexts. MemFlex is considered safe and focuses on making memory more adaptable, which might alleviate symptoms related to OUD. The treatment aims to strengthen memory processes, possibly leading to better outcomes for those facing opioid-related challenges. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with opioid use disorder (OUD) who are interested in participating in a study to improve memory function. Participants will undergo drug testing and must be willing to complete at-home memory training and assessments involving brain and heart activity monitoring.

Inclusion Criteria

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

I have been on a stable dose of medication for opioid use disorder for at least 2 weeks.

OUD subjects must have a lifetime self-reported history of OUD (according to DSM-5 criteria)

Exclusion Criteria

HC subjects must not have a positive urine drug screen for any tested substances at screening or the baseline assessment visit (a test may be repeated if needed to confirm accuracy)

I am currently taking opioid medication for pain or another condition.

Current severe psychiatric (e.g., bipolar disorder) or physical (e.g., dementia, Parkinson's disease) conditions determined by self-reported history or physical exam and deemed by PI to significantly interfere with brain function or make the study hazardous for the subject

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline assessment including fNIRS and heartbeat data collection

1 week

1 visit (in-person)

Treatment

Participants undergo four weeks of at-home memory training (MemFlex)

4 weeks

At-home sessions

Post-treatment Follow-up

Participants complete a follow-up assessment including fNIRS and heartbeat data collection

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MemFlex

Trial Overview

The intervention being tested is MemFlex, a cognitive-behavioral therapy aimed at improving symptoms of OUD through memory training. All participants will receive this intervention without the comparison of a placebo group.

How Is the Trial Designed?

Group I: OUD Experimental Treatment 1 Intervention

Participants who meet criteria for OUD and are on a stable dose of medication assisted therapy for OUD will be trained in memory flexibility training (MemFlex) - cognitive training exercises.

Group II: Healthy controls Active Control 1 Intervention

Participants who meet criteria as healthy volunteers, will receive no MemFlex training but will undergo assessments as well as fNIRS computerized tasks.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

Medication-Assisted Treatment (MAT) for opioid use disorder shows mixed effects on functional outcomes, with some studies indicating poorer cognitive performance, such as working memory and cognitive speed, compared to healthy controls.

While MAT users may experience lower fatigue rates with buprenorphine compared to methadone, the overall quality of evidence regarding functional outcomes is low, highlighting the need for more rigorous studies to draw stronger conclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of medication assisted treatment (MAT) for opioid use disorder on functional outcomes: A systematic review. Maglione, MA., Raaen, L., Chen, C., et al.[2019]

Methadone and buprenorphine-naloxone are effective long-term maintenance medications for opioid use disorders (OUDs), positively impacting the health of individuals with opioid addiction.

Despite their effectiveness, the use of buprenorphine and naltrexone is limited due to stigma and barriers in access to treatment, highlighting the need for improved education and resources in the medical community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status of opioid addiction treatment and related preclinical research. Kreek, MJ., Reed, B., Butelman, ER.[2023]

Over 2 million Americans have opioid use disorder, which is partly due to overprescribing, highlighting the need for better opioid stewardship and management strategies by physicians.

Three FDA-approved medications—methadone, buprenorphine, and naltrexone—are effective for treating opioid use disorder, but successful outcomes are best achieved through comprehensive, interprofessional management plans rather than relying solely on medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescription Drug and Alcohol Use Disorders: Opioid Use Disorder. Witt, L., Butler, F.[2019]

Medications like methadone, buprenorphine, and extended-release naltrexone are effective in improving outcomes for individuals with opioid use disorder, but their effectiveness is often hindered by challenges in diagnosis, treatment entry, and retention.

There is a critical need to enhance the use of these medications through better training for healthcare professionals and the development of new treatment models to provide personalized care for those affected by opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of opioid use disorder in the USA: present status and future directions. Blanco, C., Volkow, ND.[2019]

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