Noninferiority Clinical Trial of Adapted START NOW Psychotherapy for Outpatient Opioid Treatment.

Medications for opioid use disorder (MOUD) such as buprenorphine is effective for treating opioid use disorder (OUD). START NOW (SN) is a manualized, skills-based group psychotherapy originally developed and validated for the correctional population and has been shown to result in reduced risk of disciplinary infractions and future psychiatric inpatient days with a dose response effect. We investigate whether adapted START NOW is effective for treating OUD in a MOUD office-based opioid treatment (OBOT) setting in this non-inferiority clinical trial. Patients enrolled in once weekly buprenorphine/suboxone MOUD OBOT were eligible for enrollment in this study. Participants were cluster-randomized, individually-randomized, or not randomized into either START NOW psychotherapy or treatment-as-usual (TAU) for 32 weeks of therapy. Treatment effectiveness was measured as the number of groups attended, treatment duration, intensity of attendance, and overall drug use as determined by drug screens. 137 participants were quasi-randomized to participate in SN (n = 79) or TAU (n = 58). Participants receiving START NOW psychotherapy, when compared to TAU, had comparable number of groups attended (16.5 vs. 16.7, p = 0.80), treatment duration in weeks (24.1 vs. 23.8, p = 0.62), and intensity defined by number of groups attended divided by the number of weeks to last group (0.71 vs. 0.71, p = 0.90). SN compared to TAU also had similar rates of any positive drug screen result (81.0% vs. 91.4%, p = 0.16). This suggests that adapted START NOW is noninferior to TAU, or the standard of care at our institution, for treating opioid use disorder. Adapted START NOW is an effective psychotherapy for treating OUD when paired with buprenorphine/naloxone in the outpatient group therapy setting. Always free and publicly available, START NOW psychotherapy, along with its clinician manual and training materials, are easily accessible and distributable and may be especially useful for low-resource settings in need of evidence-based psychotherapy.