MedSMA℞T Mobile for Opioid Addiction

Not yet recruiting at 2 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Olufunmilola Abraham

Must be taking: Opioids

Disqualifiers: No adolescent, Non-English speakers, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new smartphone-based intervention called MedSMA℞T Mobile to determine if it improves knowledge and attitudes about opioid misuse compared to traditional counseling alone. Participants will receive standard counseling and access to a serious game on their smartphone designed to educate about opioid safety. The trial seeks adults who have received an opioid prescription from a participating emergency department and have a child aged 12-18 living at home. Participants must speak English and be able to provide consent. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance opioid safety education.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this smartphone-based intervention is safe for participants?

Research shows there isn't specific safety information for MedSMA℞T Mobile yet. However, MedSMA℞T Mobile, an app used on smartphones to educate and engage users, is generally considered safe since it is not a medication or medical procedure.

Previous studies on similar apps, such as MedSMA℞T Families, have shown positive results in promoting safe opioid use. These studies suggest that users receive the app well and it doesn't have known side effects. For concerns about joining a trial, consulting a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MedSMA℞T Mobile for opioid addiction because it introduces a novel approach by using a serious game to educate patients while entertaining them. Unlike traditional treatments which rely on counseling and medication, MedSMA℞T Mobile aims to engage patients actively through interactive gameplay, enhancing their understanding of opioid safety. This innovative method could improve patient engagement and retention, potentially leading to better outcomes in managing addiction.

What evidence suggests that the MedSMA℞T Mobile intervention is effective for opioid misuse?

Research has shown that MedSMA℞T Mobile, a smartphone app, may improve understanding and attitudes about opioid misuse. In this trial, participants in the intervention group will receive MedSMA℞T Mobile alongside standard opioid-related counseling. An initial study demonstrated that a similar app increased interest in treatment among adults with opioid use disorder. Another study found that teenagers using the MedSMA℞T Families app learned more about safe behavior related to opioids. These findings suggest that the app can be a useful tool for educating users about opioid safety and encouraging positive attitudes towards managing opioid use. ^{1 2 3 4 6}

Who Is on the Research Team?

Olufunmilola Abraham, PhD

Principal Investigator

University of Kentucky College of Pharmacy

Are You a Good Fit for This Trial?

This trial is for parents and their adolescent/early adult children who are dealing with opioid addiction. Participants must be willing to use a smartphone-based intervention, attend online meetings, provide demographic information, and complete various surveys about opioids over the course of 9 months.

Inclusion Criteria

Adults who speak and understand English

Each participant must have the ability to provide informed consent

I received an opioid prescription from the emergency department.

Exclusion Criteria

I have not received opioids from the emergency department for this study.

Adults who do not speak or understand English

I am unable to give informed consent by myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants join an online meeting to test the smartphone-based intervention and complete a family medication safety plan

1 week

1 online meeting

Follow-up

Participants complete surveys about opioids and report demographic information at baseline, 3, 6, and 9 months

9 months

Surveys at baseline, 3, 6, and 9 months

What Are the Treatments Tested in This Trial?

Interventions

• MedSMA℞T Mobile

Trial Overview

The study is testing 'MedSMA℞T Mobile,' a new smartphone app designed to enhance traditional counseling for opioid misuse. It aims to see if using the app can improve knowledge and attitudes towards opioid misuse more effectively than counseling alone.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

This group will receive the intervention of interest, MedSMA℞T Mobile, in addition to standard opioid-related counseling. MedSMA℞T Mobile is a serious game (intended to educate while entertaining) focused on opioid safety.

Group II: Control Active Control 1 Intervention

This group will receive the standard opioid-related counseling that all patients receive when newly prescribed opioids in the emergency department.

Who Is Running the Clinical Trial?

Olufunmilola Abraham

Lead Sponsor

Trials

1

Recruited

240+

Published Research Related to This Trial

A study is being conducted to evaluate the effectiveness of a smartphone app called OptiMAT as an adjunctive intervention for improving outcomes in medication-assisted treatment (MAT) for opioid use disorder (OUD), specifically targeting individuals in outpatient settings.

The trial will compare two groups: one receiving standard MAT and the other receiving MAT with the OptiMAT app, assessing opioid misuse through urinalysis over a 6-month period, which could lead to better treatment strategies in rural areas heavily affected by the opioid crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. Thompson, RG., Bollinger, M., Mancino, MJ., et al.[2023]

In a study of 414 participants over 16 months, combining medication for opioid use disorder (MOUD) with the A-CHESS smartphone intervention did not significantly improve overall abstinence from illicit opioid use compared to MOUD alone.

However, for participants without withdrawal symptoms and those on methadone, the combination of MOUD+A-CHESS showed higher abstinence rates and greater meeting attendance, suggesting potential benefits for specific groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Bundling Medication for Opioid Use Disorder With an mHealth Intervention Targeting Addiction: A Randomized Clinical Trial. Gustafson, DH., Landucci, G., Vjorn, OJ., et al.[2023]

A new standardized strategy for reporting adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials was developed, which aims to reduce the reporting burden while maintaining safety monitoring.

In a review of 17 SUD trials involving 6737 participants, the new strategy showed a significant reduction in irrelevant safety event reporting, leading to a more consistent safety assessment system tailored to the risks associated with specific trial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. Lindblad, R., Campanella, M., Styers, D., et al.[2013]

A survey of 71 opiate-dependent adults in a buprenorphine treatment program revealed that nearly all participants owned mobile phones and were comfortable using text messaging, indicating a strong potential for mobile technology in addiction treatment.

Most participants preferred having direct access to their providers via mobile phone and expressed interest in using text messaging to alert their clinic about potential relapses, suggesting that mobile interventions could enhance patient engagement and support in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile phone use patterns and preferences in safety net office-based buprenorphine patients. Tofighi, B., Grossman, E., Buirkle, E., et al.[2018]

A pilot study involving 26 adults with opioid use disorder (OUD) showed that using the mobile app 'uMAT-R' significantly increased interest in treatment from 32% to 48%.

Participants also reported improved attitudes towards medication-assisted treatment (MAT), with 88% believing the app would be helpful in making recovery decisions, indicating its potential as a supportive tool in addressing the opioid epidemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. Cavazos-Rehg, PA., Krauss, MJ., Costello, SJ., et al.[2021]

The study aims to review the current landscape of mobile apps designed to prevent and manage opioid-related harm, highlighting their potential as a public health intervention.

The review will analyze various aspects of these apps, including their availability across different operating systems, features, target user groups, and user ratings, to assess their effectiveness and usability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Mobile Apps for Prevention and Management of Opioid-Related Harm. Aggarwal, M., Borycki, EM.[2019]

A study of 1244 opioid-dependent individuals found that those who stopped naltrexone treatment experienced significantly higher overdose rates (39 overdoses per 100 person-years) compared to those who left agonist treatments, indicating a critical risk period immediately after stopping naltrexone.

Overall, individuals who left any pharmacotherapy for opioid dependence had much higher rates of serious adverse events and deaths (six per 100 person-years) compared to when they were in treatment, highlighting the need for ongoing support and risk education after treatment cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD). Digiusto, E., Shakeshaft, A., Ritter, A., et al.[2022]

Mobile phone applications, when used alongside standard addiction treatments, can enhance the effectiveness of these treatments by providing tools for information, monitoring, motivation, and relapse prevention.

Most studies reviewed indicated that patients using these applications experienced a greater reduction in substance consumption compared to those receiving standard treatment alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mobile phone applications for addiction treatment]. Penzenstadler, L., Thorens, G., Bachmann, S.[2022]

A study analyzing adverse drug reactions (ADRs) related to weak opioid analgesics from 2011 to 2020 found that tramadol was the most commonly reported drug, particularly affecting young women, with gastrointestinal symptoms being the most frequent.

Serious ADRs were more commonly reported in the Pharmacovigilance database, especially for codeine, but no fatalities were observed, indicating a generally safe profile for weak opioids despite the occurrence of ADRs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in adverse drug reactions related to oral weak opioid analgesics in therapeutic use in adults: A 10-year French vigilances retrospective study. Caré, W., Pinel, S., Dufayet, L., et al.[2023]

Citations

1.

publications.aap.org

publications.aap.org/pediatricsopenscience/article/doi/10.1542/pedsos.2024-000172/200932

Using MedSMA℞T Families for Opioid Safety Education

This study aimed to characterize ED staff's perspectives on implementing the MedSMA℞T Families intervention in the ED to improve opioid education and safety ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12226961/

Adolescents' and Parents' Perspectives on Using the ...

This study aimed to explore and characterize adolescents' and parents' experiences and perspectives on implementing the MedSMA℞T Families intervention in the ...

3.

withpower.com

withpower.com/trial/medsmat-mobile-for-opioid-addiction-e5a69

MedSMA℞T Mobile for Opioid Addiction · Info for Participants

A pilot study involving 26 adults with opioid use disorder (OUD) showed that using the mobile app 'uMAT-R' significantly increased interest in treatment from 32 ...

4.

mdpi.com

mdpi.com/2226-4787/11/5/143

MedSMA℞T Adventures in PharmaCity Game: Youth ...

Among those aged 14 to 18, the increase in overdose death was 94% from 2019 to 2021 with an additional increase of 20% from 2020 to 2021 [10]. Often, when ...

5.

pubs.lib.umn.edu

pubs.lib.umn.edu/index.php/innovations/article/download/5678/3491/31275

An Overview of the CRoME Lab's MedSMA℞T Families ...

Empirical evidence of efficacy from two separate studies denotes improvement in key concepts related to safe behavior in adolescents. Findings to date support ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10936453/

An Overview of the CRoME Lab's MedSMA℞T Families ...

Findings to date support the widespread use, implementation, and dissemination of this efficacious intervention to supporting safe opioid prescription practices ...