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Active Not Recruiting
NCT05039554
Randomized Trial of ACT and a Care Management App in Primary Care-based Buprenorphine Treatment
Conditions: Opioid-use Disorder, Chronic Pain
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 125
Sponsor: Albert Einstein College of Medicine
Location: Montefiore Medical Center The Bronx New York
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
Source: ClinicalTrials.gov (NCT05039554). StuddyBuddy aggregates publicly available trial information.