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Integrating psychiatric services within substance abuse treatment settings is a promising service delivery model, but has not been evaluated using random assignment to psychiatric treatment setting and controlled delivery of psychiatric care. This study evaluates the efficacy of on-site and integrated psychiatric service delivery in an opioid-agonist treatment program on psychiatric and substance use outcomes.Participants at the Addiction Treatment Services (ATS) were assigned randomly to receive on-site and integrated substance abuse and psychiatric care (on-site: n = 160) versus off-site and non-integrated substance abuse and psychiatric care (off-site: n = 156), and observed for 1 year. On-site participants received all psychiatric care within the substance abuse program by the same group of treatment providers. The same type and schedule of psychiatric services were available to off-site participants at a community psychiatry program.All participants received routine methadone maintenance at the ATS program in Baltimore, Maryland, USA.Participants were opioid-dependent men and women with at least one comorbid psychiatric disorder, as assessed by the Structured Clinical Interview for DSM-IV and confirmed by expert clinical reappraisal.Outcomes included psychiatric service utilization and retention, Hopkins Symptom Checklist Global Severity Index (GSI) change scores and urinalysis test results.On-site participants were more likely to initiate psychiatric care 96.9 to 79.5%; P < 0.001), remain in treatment longer (195.9 versus 101.9 days; P < 0.001), attend more psychiatrist appointments (12.9 versus 2.7; P < 0.001) and have greater reductions in GSI scores (4.2 versus 1.7; P = 0.003) than off-site participants; no differences were observed for drug use.On-site and integrated psychiatric and substance misuse services in a methadone treatment setting might improve psychiatric outcomes compared with off-site and non-integrated substance misuse and psychiatric care. However, this might not translate into improved substance misuse outcomes.