MedSMA℞T Mobile for Opioid Addiction

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

244 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if a new smartphone-based intervention can help with factors related to opioid misuse in parents and adolescent/early adult children. The main question it aims to answer is: • Can this intervention improve knowledge of, and attitudes towards, opioid misuse over traditional opioid-related counseling alone? Participants will, in addition to receiving opioid counseling: * Join an online meeting with research staff to test the smartphone-based intervention * Report demographic information * Complete surveys about opioids * Complete a family medication safety plan * Complete surveys after 3, 6, and 9 months

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 data supports the effectiveness of the treatment MedSMA℞T Mobile for opioid addiction?

Research shows that using mobile apps alongside standard treatments for addiction can help reduce substance use. For example, smartphone interventions like A-CHESS and OptiMAT have been shown to improve outcomes for people receiving medication-assisted treatment for opioid use disorder. ^{1 2 3 4 5}

Is MedSMA℞T Mobile safe for humans?

There is no specific safety data available for MedSMA℞T Mobile, but general studies on opioid treatments highlight the importance of monitoring for adverse events (unwanted side effects) and serious adverse events during treatment. ^{6 7 8 9 10}

How is the MedSMA℞T Mobile treatment for opioid addiction different from other treatments?

MedSMA℞T Mobile is unique because it uses mobile health technology to support opioid addiction treatment, making it more accessible and potentially more engaging for patients. Unlike traditional treatments, it can provide real-time support and information, helping to overcome barriers like stigma and lack of access to professional care. ^{1 3 11 12 13}

Research Team

Olufunmilola Abraham, PhD

Principal Investigator

University of Kentucky College of Pharmacy

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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 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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Mobile phone use patterns and preferences in safety net office-based buprenorphine patients. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of Bundling Medication for Opioid Use Disorder With an mHealth Intervention Targeting Addiction: A Randomized Clinical Trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

[Mobile phone applications for addiction treatment]. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Serious adverse events in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD). [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Steps to Improve Understanding of Prescription Opioid Risks. [2021]

9. Canada pubmed.ncbi.nlm.nih.gov

Retrospective analysis of opioid medication incidents requiring administration of naloxone. [2023]

10. England 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. [2023]

11. Canada pubmed.ncbi.nlm.nih.gov

Feasibility and Preliminary Efficacy of a Community-Based Addiction Rehabilitation Electronic System in Substance Use Disorder: Pilot Randomized Controlled Trial. [2021]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Review of Mobile Apps for Prevention and Management of Opioid-Related Harm. [2019]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluating the effectiveness of mobile app-based self-guided psychological intervention to reduce craving and lapse risk in problematic substance use and behaviors: Protocol for a randomized control trial in the general population. [2023]