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

NARecruitingINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

February 2, 2023

Primary Completion Date

April 30, 2027

Study Completion Date

April 30, 2027

Conditions
Opioid-use DisorderChronic Pain
Interventions
BEHAVIORAL

Acceptance and commitment therapy

Intervention will be provided over 12 weeks with weekly 1-hour sessions using a group format with the overall goal to foster psychological flexibility. ACT will assist participants to notice their internal triggers; abandon their attempts to manage these triggers via active avoidance (suppression or other control-based strategies including opioid or other substance use) and to make commitments to engage in behaviors consistent with their chosen values or goals (rather than allowing negative thoughts, feelings, or pain symptoms to dictate behavior).

OTHER

Valera Smartphone Application

For those randomized to a cohort with the Valera app, the app (and cellphones if necessary) will be provided. The app is HIPAA compliant and IRB approved. It consists of 2 components: a participant-facing Smartphone Application and a corresponding online Care Manager Dashboard. Smartphones and internet access will be provided as needed for the 12-week study duration.

OTHER

Treatment as Usual

TAU for BUP treatment typically consists of regularly scheduled visits every 1-2 months with primary care physicians and/or nurse care managers in Montefiore primary care settings. During these 15-min follow up visits, providers typically inquire about opioid and other substance use, opioid craving, symptoms of opioid withdrawal, and risk of relapse. In addition, at each visit, urine toxicology tests are conducted and providers review results of prior urine toxicology tests with patients. If opioid or other substance use is ongoing, typically providers will intensify treatment, including increasing the frequency of visits, referring to social workers or mental health providers, recommending self-help groups, and/or recommending outpatient drug treatment programs (e.g., individual and group counseling).

Trial Locations (1)

10461

RECRUITING

Montefiore Medical Center, The Bronx

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Albert Einstein College of Medicine

OTHER