NCT05039554 Randomized Trial of ACT and a Care Management App in Primary Care-based Buprenorphine Treatment
| NCT ID | NCT05039554 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Albert Einstein College of Medicine |
| Condition | Opioid-use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 127 participants |
| Start Date | 2023-02-02 |
| Primary Completion | 2027-04-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 127 participants in total. It began in 2023-02-02 with a primary completion date of 2027-04-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Hector Perez, MD
PRINCIPAL INVESTIGATOR
Albert Einstein College of Medicine Montefiore Medical Center
Frequently Asked Questions
Who can join the NCT05039554 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Opioid-use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05039554 currently recruiting?
Yes, NCT05039554 is actively recruiting participants. Contact the research team at heperez@montefiore.org for enrollment information.
Where is the NCT05039554 trial being conducted?
This trial is being conducted at The Bronx, United States.
Who is sponsoring the NCT05039554 clinical trial?
NCT05039554 is sponsored by Albert Einstein College of Medicine. The principal investigator is Hector Perez, MD at Albert Einstein College of Medicine Montefiore Medical Center. The trial plans to enroll 127 participants.