ACT + Care Management App for Opioid Use Disorder

Recruiting at 1 trial location

Overseen By Hector Perez, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Albert Einstein College of Medicine

Must be taking: Buprenorphine

Disqualifiers: Acute mania, Psychosis, Suicidality, others

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

160 Participants Needed

Trial Summary

What is the purpose of this trial?

The proposed IMPOWR Research Center at Montefiore-Einstein (IMPOWR-ME) will create a multidisciplinary and synergistic program of research to test multimodal treatments that address both chronic pain and opioid use disorder. IMPOWR-ME will generate critical knowledge about the effectiveness, implementation, and cost effectiveness of providing Acceptance and Commitment Therapy and/or a care management smartphone app for individuals in primary care-based buprenorphine treatment. Patients with lived experience with chronic pain and/or opioid use disorder, patient and policy advocates, payors, and health system partners will be engaged in all stages of the research. IMPOWR-ME is well-positioned to become a long-lasting hub for stakeholder-engaged research with multidisciplinary senior and early stage investigators focused on reducing overdose through better treatments for OUD and CP.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it allows the use of psychotropic medications (drugs affecting mood, perception, or behavior).

What data supports the effectiveness of the treatment Acceptance and Commitment Therapy (ACT) and the Valera Smartphone Application for Opioid Use Disorder?

While there is no direct evidence from the provided research about ACT and the Valera Smartphone Application for opioid use disorder, ACT has been shown to be effective in treating other conditions by helping individuals accept their thoughts and feelings and commit to personal values, which may indirectly support its use in opioid use disorder treatment. ^{1 2 3 4 5}

Is the ACT + Care Management App for Opioid Use Disorder safe for humans?

The research articles provided do not contain specific safety data for the ACT + Care Management App or related treatments like Acceptance and Commitment Therapy or the Valera Smartphone Application for opioid use disorder. ^{1 3 6 7 8}

How is Acceptance and Commitment Therapy (ACT) different from other treatments for opioid use disorder?

ACT is unique because it focuses on helping individuals accept their thoughts and feelings rather than trying to change them, and it encourages commitment to personal values as a way to guide behavior. This approach is different from traditional treatments that often focus on changing thought patterns or behaviors directly. ^{1 6 7 9 10}

Research Team

Tiffany Liu, MD

Principal Investigator

Montefiore

Brianna Norton, DO

Principal Investigator

Montefiore

Hector Perez, MD

Principal Investigator

Albert Einstein College of Medicine Montefiore Medical Center

Eligibility Criteria

This trial is for adults over 18 who are already receiving buprenorphine treatment for opioid use disorder and have chronic pain with moderate severity. Participants must speak English or Spanish and not be in new psychotherapy, using similar smartphone apps, or having recent changes in psychotropic meds.

Inclusion Criteria

I experience moderate to severe chronic pain.

I am 18 years old or older.

I have been on a stable dose of BUP for OUD treatment at Montefiore for over a month.

Exclusion Criteria

Unable or unwilling to provide signed consent for participation

I haven't changed my mental health medications in the last 3 months.

I started seeing a therapist for mental health within the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Acceptance and Commitment Therapy (ACT) and/or a care management smartphone app in primary care-based buprenorphine treatment

24 weeks

Regular visits as per treatment protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• Acceptance and commitment therapy
• Valera Smartphone Application

Trial Overview The study tests if Acceptance and Commitment Therapy (ACT) and a care management app can help people with chronic pain and opioid use disorder who are getting buprenorphine treatment. It aims to see how effective these approaches are when added to usual treatments.

Participant Groups

Group I: ACT + Valera app Experimental Treatment 2 Interventions

Participants randomized to this cohort will receive both acceptance and commitment therapy (ACT) and the Valera app (and a smartphone with network connectivity if necessary).

Group II: Valera smartphone application (app) alone Active Control 1 Intervention

Participants randomized to this cohort will receive the Valera app and will receive a smartphone with network connectivity if necessary.

Group III: treatment as usual (TAU) Placebo Group 1 Intervention

Participants randomized to this cohort will not receive any experimental treatments.

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine

Lead Sponsor

Trials

302

Recruited

11,690,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

The Patient Decision Aid for Medication Treatment for Opioid Use Disorder (PtDA-MOUD) was developed with input from experts and patients, and it effectively provided information to help patients make informed treatment decisions during their initial clinical visit.

In a pilot test with 36 patients, those who used the PtDA-MOUD were more likely to start medication treatment for opioid use disorder (37% vs. 11% in controls) and received treatment for more days on average, suggesting that the decision aid may enhance treatment initiation and engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient decision aid for medication treatment for opioid use disorder (PtDA-MOUD): Rationale, methodology, and preliminary results. Mooney, LJ., Valdez, J., Cousins, SJ., et al.[2021]

The Comprehensive Addictions Recovery Act has expanded the ability of nurse practitioners and physician assistants to prescribe buprenorphine, a medication that helps stabilize individuals dependent on opioids.

Addiction and psychiatric nurses are crucial in providing group therapy alongside medication-assisted treatment, as this approach helps individuals develop skills necessary for long-term recovery from substance use and co-occurring disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recovery Beyond Buprenorphine: Nurse-Led Group Therapy. Fogger, SA., Lehmann, K.[2018]

The Drug Abuse Treatment Act of 2000 (DATA) expanded treatment options for opioid addiction by allowing certified physicians to prescribe buprenorphine in office settings, increasing access to care.

Clinical studies show that buprenorphine is as effective as methadone for maintaining treatment and reducing illicit opioid use, and it is more effective than clonidine for short-term detoxification, highlighting its role as a valuable tool in addiction treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupreorphine:a new pharmacotherapy for opioid addictions treatment. Stock, C., Shum, JH.[2013]

A focus group study with 33 clinicians revealed that systemic and attitudinal barriers still hinder the screening, diagnosis, and treatment of opioid use disorder (OUD), despite the availability of effective treatments.

Clinicians responded positively to a software-delivered measurement-based care (MBC) model, suggesting it could enhance access to OUD treatment, but emphasized the need for additional efforts to address stigma before such tools can be effectively implemented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stigma towards opioid use disorder in primary care remain a barrier to integrating software-based measurement based care. Dela Cruz, AM., Karns-Wright, T., Kahalnik, F., et al.[2023]

The implementation of New Jersey's Office-Based Addiction Treatment (OBAT) Program in 2019 led to a steady increase in provider enrollment and utilization of medications for opioid use disorder (MOUD), indicating improved access to treatment for patients.

While enhanced reimbursements and patient navigation services were beneficial, barriers such as limited enrollment of primary care physicians and administrative challenges hindered broader uptake of the program, suggesting that further adaptations could enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of an office-based addiction treatment model for Medicaid enrollees: A mixed methods study. Treitler, P., Enich, M., Bowden, C., et al.[2023]

A web-based self-management intervention for chronic pain patients on opioids was developed based on feedback from 53 participants, highlighting the need for additional pain management strategies and the importance of goal setting.

Participants found the web-based tool potentially useful and acceptable, indicating that it effectively increased their knowledge about self-management of chronic pain, suggesting a promising approach for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain. Moore, SK., Guarino, H., Acosta, MC., et al.[2022]

In a study of 170 adults with opioid use disorder, those receiving a digital therapeutic alongside standard treatment had significantly higher rates of opioid abstinence (77.3% vs. 62.1%) during the final weeks of treatment.

The digital therapeutic also improved treatment retention, with participants less likely to leave treatment compared to those receiving standard care alone, while showing no increase in adverse events, indicating it is a safe and effective addition to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. Maricich, YA., Bickel, WK., Marsch, LA., et al.[2022]

The US Department of Veterans Affairs has prioritized increasing access to effective treatments for opioid use disorder (OUD), particularly through the use of medications like buprenorphine, methadone, and injectable naltrexone.

Despite system-wide efforts, the adoption of these medications has been inconsistent across different VA facilities and among vulnerable patient groups, highlighting the need for targeted strategies to improve access and utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medications for opioid use disorder in the Department of Veterans Affairs (VA) health care system: Historical perspective, lessons learned, and next steps. Wyse, JJ., Gordon, AJ., Dobscha, SK., et al.[2022]

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]

Project RAMP successfully recruited 26 primary care practices across 13 counties in Pennsylvania to provide medications for opioid use disorder (MOUD), exceeding their target and demonstrating effective strategies for engaging rural healthcare providers.

Key recruitment strategies included leveraging health system leadership support and addressing barriers faced by providers, such as lack of training, which facilitated better communication and integration of care for patients with opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies to recruit rural primary care providers to implement a medication for opioid use disorder (MOUD) focused integrated care model. Cloutier, RM., Cole, ES., McDonough, BL., et al.[2023]

References

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

Patient decision aid for medication treatment for opioid use disorder (PtDA-MOUD): Rationale, methodology, and preliminary results. [2021]

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

Recovery Beyond Buprenorphine: Nurse-Led Group Therapy. [2018]

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

Bupreorphine:a new pharmacotherapy for opioid addictions treatment. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Stigma towards opioid use disorder in primary care remain a barrier to integrating software-based measurement based care. [2023]

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

Implementation of an office-based addiction treatment model for Medicaid enrollees: A mixed methods study. [2023]

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

Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain. [2022]

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

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. [2022]

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

Medications for opioid use disorder in the Department of Veterans Affairs (VA) health care system: Historical perspective, lessons learned, and next steps. [2022]

9. 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]

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

Strategies to recruit rural primary care providers to implement a medication for opioid use disorder (MOUD) focused integrated care model. [2023]