ACT + Care Management App for Opioid Use Disorder

Recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to assist individuals managing both chronic pain and opioid use disorder. Researchers are testing whether Acceptance and Commitment Therapy (ACT, a type of talk therapy) and a care management smartphone app can enhance treatment for those already using buprenorphine (a medication for opioid use disorder). Participants will be divided into groups receiving either both the therapy and app, just the app, or their usual treatment. The trial is suitable for English or Spanish speakers who have been on buprenorphine for at least two weeks and experience moderate chronic pain affecting their daily life. As an unphased trial, this study offers a unique opportunity to contribute to innovative treatment approaches that could improve quality of life.

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).

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Acceptance and Commitment Therapy (ACT) is generally well-received by individuals dealing with substance use issues. In one study, individuals at risk of misusing opioids found the therapy very acceptable. Another study found that ACT helped participants stop using opioids and manage pain faster than standard care.

Specific safety information about the Valera smartphone app isn't available. However, app-based treatments are usually low-risk because they don't involve medications or physical procedures.

Overall, both ACT and the Valera app appear to be safe options for those interested in addressing opioid use disorders, with ACT having a more established record of user acceptance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ACT + Care Management App for opioid use disorder because it combines acceptance and commitment therapy (ACT) with the innovative Valera app. Unlike traditional treatments like medication-assisted therapy (MAT), which primarily focuses on reducing withdrawal symptoms, this approach integrates mental health support directly through a smartphone app. The app enhances accessibility and continuous support, offering personalized care that can be more flexible and engaging than conventional face-to-face therapy. By leveraging technology, this method has the potential to reach more individuals in real-time, providing on-the-go assistance and potentially improving overall treatment outcomes.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

In this trial, participants will join different treatment arms to evaluate the effectiveness of Acceptance and Commitment Therapy (ACT) and the Valera smartphone app. Research has shown that ACT effectively helps people with substance use problems by reducing the use of substances like opioids, improving mood, and lessening pain's impact on daily life. ACT also reduces feelings of depression and anxiety in these individuals.

Participants in one arm will receive both ACT and the Valera app. Early results suggest that the Valera app can enhance treatment for opioid use disorder, helping people manage their condition better when combined with medication. Another arm will receive the Valera app alone, while a third arm will follow treatment as usual without any experimental treatments. Together, ACT and the app may offer a promising way to support those dealing with opioid use disorder and chronic pain. ^{1 6 7 8 9}

Who Is on the Research Team?

Tiffany Liu, MD

Principal Investigator

Montefiore

Hector Perez, MD

Principal Investigator

Albert Einstein College of Medicine Montefiore Medical Center

Brianna Norton, DO

Principal Investigator

Montefiore

Are You a Good Fit for This Trial?

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

I am proficient in English or Spanish.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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 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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S221214472400053X

Effectiveness of acceptance and commitment therapy for ... Three previous systematic reviews have concluded that ACT has a positive effect on treatment outcomes for substance use disorders. Specifically, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7524566/

The Use of Acceptance and Commitment Therapy in ... Most of the studies showed that ACT was effective in the management of SUD showing significant evidence of a reduction in substance use or total ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/24740527.2017.1325317

Acceptance and Commitment Therapy to manage pain and ... Preliminary outcomes suggest that ACT was effective in reducing opioid use while pain interference and mood improved.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06581276

Study Details | NCT06581276 | Increasing Access to ... Acceptance and Commitment Therapy (ACT) is an evidence-based behavioral pain treatment intervention for Chronic Pain, anxiety and depression, and substance use ...

5. brieflands.com brieflands.com/articles/ijpbs-110135

Effectiveness of Acceptance and Commitment Therapy in ... Based on the results, ACT had a significant effect on depression and anxiety in people with substance use disorders. The present research results showed that ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10270682/

An acceptance and commitment therapy-based ... Ten patients with moderate to high risk of opioid misuse completed the intervention. Patients rated the intervention as highly acceptable and were generally ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06581276

Study Details | NCT06581276 | Increasing Access to ... The study team administered baseline and follow-up questionnaires upon completion of the ACT intervention to assess changes in clinical outcomes. Completion of ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3386351/

A Stage I Pilot Study of Acceptance and Commitment ... While no difference was found on opioid use during treatment, 37% of participants in the ACT condition were successfully detoxified at the end ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1526590018301822

Acceptance and Commitment Therapy for Prevention of ... Participants who completed the ACT workshop reached pain and opioid cessation sooner than those in TAU. Postoperative complications exhibited a moderating ...