Manualized Psychosocial Treatment Versus Standard Care in Opioid Maintenance Treatment: Results of a Randomized Clinical Trial and Follow-up Study

Abstract

Psychosocial interventions play an unclear complex role within maintenance treatment for opioid addiction. In this study, the hypothesis was that manualized psychosocial treatment was more effective than psychosocial treatment as usual. Moreover, the question was to find subgroups of patients who do not need or benefit from enhanced psychosocial treatment. The study design contains two manualized treatment groups and a control group of treatment as usual. There are two randomizations: (1) From the beginning, all patients were randomized to methadone or buprenorphine. (2) After having finished the control group treatment-as-usual, the subsequent patients were in addition randomly allocated to basic treatment or indicative treatment. From 122 patients in 3 treatment centers, 64 could be reached at the 1-year follow-up. Measurement instruments were the EuropASI, SCL-90, and documentation standards. Primary outcome criteria were drug consumption in the follow-up period of 6 months; secondary outcome criteria included individual changes in the EuropASI composite scores and the SCL-90 scales. Regarding hard drugs (all illegal drugs except cannabis, but including non-prescribed tranquilizers) the proportion of patient without use of drugs in the last 30 days increased from 1.9 % at intake to 54.7 % in the last month of the follow-up period without differences in the 3 psychosocial treatment groups. 76.1 % of those patients with at least one increased T-value ([60) in any of the 9 SCL scales showed at least one positive individual change in the follow-up period, whereas only 12.5 % of those with no increased T-value showed any positive changes. Regarding the use of hard drugs in the follow-up no psychosocial treatment was superior. The flexibility of psychosocial treatment as to meeting individual needs of the patients seems to be crucial. Those patients without a higher SCL-90 T-score may not require an intensive psychosocial treatment package.