Randomized Trial of ACT and a Care Management App in Primary Care-based Buprenorphine Treatment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlbert Einstein College of Medicine

About this trial

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

Qualifiers

18 years old or older;

English or Spanish proficiency;

receiving BUP treatment for OUD for at least 14 days (thus a stabilized BUP dose); and

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

Disqualifiers

Acute exacerbation of psychiatric conditions precluding the ability to participate in the study (e.g., acute mania, active suicidality/homicidality, psychosis);

psychotropic medication changes within the past three months prior to enrollment;

CP related to malignancy;

received ACT or similar therapeutic intervention in the past;

Trial design

Treatments tested in this trial

  • Acceptance and commitment therapy
  • Valera Smartphone Application
  • Treatment as Usual

Treatment groups

127 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Albert Einstein College of Medicine

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Weill Medical College of Cornell University

Collaborator

Wake Forest University Health Sciences

Collaborator

University of Miami

Collaborator

Valera Health

Collaborator

Tulane University

Collaborator