Randomized Trial of ACT and a Care Management App in Primary Care-based Buprenorphine Treatment
Active, not recruitingNot applicableNCT05039554
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Randomized Trial of Acceptance and Commitment Therapy (ACT) and a Care Management App in Primary Care-based Buprenorphine Treatment
- Conditions
- Interventions
- Behavioral: Acceptance and commitment therapy
- Other: Valera Smartphone Application
- Other: Treatment as Usual
- Sponsor
- Albert Einstein College of Medicine
- Collaborators
- National Institute on Drug Abuse (NIDA); Weill Medical College of Cornell University; Wake Forest University Health Sciences; University of Miami; Valera Health; Tulane University
- Start date
- 2023-02-02
- Primary completion
- 2027-04-29
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05039554