Two-year follow-up of an opioid-user cohort treated with high-dose buprenorphine (Subutex (R)). Results of the SPESUB study

Aim of the study. - Care for opioid users changed greatly in France in 1996 when general practitioners (GP) were allowed to prescribe high-dose sublin gual buprenorphine (Subutex(R)) for maintenance treatment of major opioid d ependence. In order to evaluate treatment benefits, a prospective epidemiol ogical 2-year follow-up was initiated in May 1996,vith the participation of 105 French GPs. Methods. - A cohort of outpatient opioid users who started high-dose sublin gual buprenorphine maintenance therapy at study onset or who had recently s tarted were included in a prospective epidemiological study by GPs involved in management of drug abusers. Patients were followed for 2 years with col lection of standardized information at 1, 3, 6, 12, and 24 months. The main evaluation criteria were follow-up by the same GP throughout the study and retention in the care system 2 years later. For patients who fulfilled the se criteria, secondary end points were analyzed: information about buprenop hine prescription, social status, and hepatitis B and C and HIV seroconvers ions. Results. - The 101 GPs included 919 patients and 909 were analyzed 2 years later. At study onset, a majority of the patients (70.6%) were taking an on going maintenance treatment, 10.5% had previously received such a treatment and the treatment was initiated for 18.8%. At the end of the study, 508 pa tients 955.9%) were still being followed by the same GP and 101 (11.1%) wer e followed by another healthcare provider (another GP, hospital or speciali zed center). No information about the care giver was available for 82 patie nts (9%). Among the other patients, 123 (13.5%) were lost to follow-up, 24 (2.6%) had moved, 23 (2.6%) were incarcerated, 11 (1.2%) had successfully d iscontinued drug usage and 7 (0.8%) had died. Other reasons for unsuccessfu l follow-up by the same GP were mainly (for 6 patients each): relapse, swit ch to methadone, no medical information, non-compliance with scheduled cont rols. Among the patients followed by the same GP, declaration of heroin and drug intake significantly decreased (p<0.001), and social status (GAF scal e) and TMSP evaluation significantly improved (p<0.001). The social situati on Chousing condition and work) also improved significantly (p<0.001). The rate of buprenorphine treatment was 84% with longer and less fractionated p rescriptions. The HBV, HBC and HIV seroconversion rates were low in this hi gh-risk population (2.7%, 4.1% and 0.8% respectively). Conclusion. - This two-pear follow-up of 909 opioid users showed that nearl y 70% of the patient remained within the healthcare system, mainly with the same GP or more rarely with another practitioner. Among the 508 patients s till followed by the same GP, maintenance treatment with high-dose buprenor phine was observed in more than 80% of the patients. These patients had a s ignificantly improved social status, a significant decrease in drug intake and a significant improvement in their social adaptation and severity of dr ug abuse.