Testing a therapy and app for treating opioid use disorder and chronic pain
Randomized Trial of Acceptance and Commitment Therapy (ACT) and a Care Management App in Primary Care-based Buprenorphine Treatment
This study is testing a new therapy and smartphone app to see if they can help people with opioid use disorder and chronic pain feel better when used alongside standard medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 123 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Albert Einstein College of Medicine Academic / other |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT05039554 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Acceptance and Commitment Therapy (ACT) and a care management smartphone application in conjunction with standard buprenorphine treatment for individuals suffering from opioid use disorder and chronic pain. Conducted at the IMPOWR Research Center in The Bronx, NY, the study will engage patients with lived experiences, advocates, and health system partners throughout the research process. The goal is to create a sustainable research infrastructure that rigorously tests integrated treatment approaches and disseminates evidence-based practices for these comorbid conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are receiving stable buprenorphine treatment for opioid use disorder and experience moderate to severe chronic pain.
Not a fit: Patients with acute psychiatric conditions, recent changes in psychotropic medications, or chronic pain related to malignancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and integrated treatment approach for patients dealing with both opioid use disorder and chronic pain.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in integrating treatments for chronic pain and opioid use disorder, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18 years old or older; 2. English or Spanish proficiency; 3. receiving BUP treatment for OUD for at least 14 days (thus a stabilized BUP dose); and 4. CP with at least moderate pain severity (score greater than or equal to 4 on Pain, Enjoyment of Life and General Activity (PEG) scale). Comorbid psychiatric conditions and use of psychotropic medications will be allowed Exclusion Criteria: 1. Acute exacerbation of psychiatric conditions precluding the ability to participate in the study (e.g., acute mania, active suicidality/homicidality, psychosis); 2. psychotropic medication changes within the past three months prior to enrollment; 3. CP related to malignancy; 4. received ACT or similar therapeutic intervention in the past; 5. initiated psychotherapy within the past three months; 6. neurocognitive conditions that may prevent participants from accessing telehealth services; 7. current use of a smartphone health platform similar to the Valera app; 8. are unable or unwilling to provide signed consent for participation
Where this trial is running
The Bronx, New York
- Montefiore Medical Center — The Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Hector Perez, MD — Albert Einstein College of Medicine Montefiore Medical Center
- Study coordinator: Hector Perez, MD
- Email: heperez@montefiore.org
- Phone: 718-920-5756
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.