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6A.2 Treatment completers

As described in chapter 5A, the population of treatment completers in the trial on injectable heroin consisted of 138 subjects (79.3% of the 174 subjects in the intention-to-treat population). These 138 subjects were compared with the remaining 36 subjects in the intention-to-treat population who did not complete the (methadone alone or co-prescribed heroin) treatment, utilizing the same set of baseline variables as displayed in paragraph 6A.1.1. With the exception of mean number of days that cocaine was used in the previous month (treatment completers: 17.3 days; non-completers: 23.6 days; t-value 3.32; df=155; p=0.0011), none of the baseline characteristics in the areas of demographic background, physical health status, psychiatric status, social functioning, and substance use showed significant differences (Bonferroni correction; overall p-value for each domain separately: p<0.10) between the two sub-populations. Hence, overall, the baseline characteristics of the treatment completers in the intention-to-treat population did not differ from those who did not complete treatment.

  • As intended, the study population consisted of chronically poor functioning, treatment-resistant heroin dependent patients. The participants had a long history of poly drug use, and participation in addiction treatments, including long-term methadone maintenance treatment. Despite earlier treatment efforts, patients had serious problems and experienced treatment needs with regard to their physical health, psychiatric status, and social functioning.
  • Within each of these domains of functioning, approximately two-thirds of the patients were included in the study. Inclusion occurred most often on the basis of poor functioning in more than one problem domain.
  • Randomization was successful, as indicated by the similarity in background characteristics, addiction history, additional problems, and inclusion profiles between the subjects in the two treatment groups