Contemporary clinical trials · 2025
The psychosocial pain management to improve opioid use disorder treatment outcomes study: Protocol for a randomized controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Ilgen Mark, Blow Frederic, Piette John D, Goldstick Jason, Lewis Mandy, Priest William, Matharu Harshpreet, Bourgoise Michael, Young Chelsea, Ashe Doctor, Price Amanda, Lin Lewei Allison
Аннотация
BACKGROUND: People with opioid use disorder (OUD) often experience comorbid chronic pain, which complicates treatment of both conditions. Medications for opioid use disorders (MOUD), specifically buprenorphine, are the standard of care for OUD and can be helpful for pain; however, a major challenge to sustaining effectiveness has been limited retention in buprenorphine treatment. Prior research has highlighted the efficacy of psychosocial treatments for pain management; although, research remains limited on integrated approaches to improve OUD outcomes among people/patients with chronic pain. This randomized controlled trial, called the Persist Study, investigated whether a psychosocial pain management intervention (PPMI) was more effective than Enhanced Usual Care (EUC) for MOUD patients with chronic pain.
METHODS: This was a randomized trial of remotely delivered PPMI vs EUC for adults receiving MOUD who have chronic pain. Our study recruited nationally from MOUD clinics and through targeted online advertisements. Target enrollment was 200 participants randomly assigned to either PPMI (n = 100) or EUC (n = 100) conditions. The PPMI consisted of eight 1-h sessions and the EUC included two 15-min sessions conducted over a 6-week timespan. Primary outcomes measured retention on buprenorphine over 3 months, whereas secondary outcomes measured longer-term MOUD retention, pain level, pain-related functioning, and frequency of substance use over 12 months.
DISCUSSION: The Persist Study tested a remotely delivered, manualized, psychosocial intervention for co-occurring chronic pain in patients prescribed buprenorphine treatment for OUD. Study results will inform efforts to improve retention and treatment outcomes among patients receiving MOUD who also have chronic pain.
TRIAL REGISTRATION: This clinical trial has been registered with ClincialTrials.gov under ID NCT04433975.
METHODS: This was a randomized trial of remotely delivered PPMI vs EUC for adults receiving MOUD who have chronic pain. Our study recruited nationally from MOUD clinics and through targeted online advertisements. Target enrollment was 200 participants randomly assigned to either PPMI (n = 100) or EUC (n = 100) conditions. The PPMI consisted of eight 1-h sessions and the EUC included two 15-min sessions conducted over a 6-week timespan. Primary outcomes measured retention on buprenorphine over 3 months, whereas secondary outcomes measured longer-term MOUD retention, pain level, pain-related functioning, and frequency of substance use over 12 months.
DISCUSSION: The Persist Study tested a remotely delivered, manualized, psychosocial intervention for co-occurring chronic pain in patients prescribed buprenorphine treatment for OUD. Study results will inform efforts to improve retention and treatment outcomes among patients receiving MOUD who also have chronic pain.
TRIAL REGISTRATION: This clinical trial has been registered with ClincialTrials.gov under ID NCT04433975.