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A prospective cohort study on orally administered heroin substitution for severely addicted opioid users
Author(s) -
Frick Ulrich,
Rehm Jürgen,
Kovacic Susanne,
Ammann Jeannine,
Uchtenhagen Ambros
Publication year - 2006
Publication title -
addiction
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.424
H-Index - 193
eISSN - 1360-0443
pISSN - 0965-2140
DOI - 10.1111/j.1360-0443.2006.01569.x
Subject(s) - medicine , heroin , retention rate , confidence interval , adverse effect , opioid , cohort , prospective cohort study , cohort study , anesthesia , drug , pharmacology , receptor , computer security , computer science
Aims To assess the efficacy and safety of orally administered heroin [diacetylmorphine (DAM)] tablets in substitution treatment of severely addicted opioid users. Design An open‐label, prospective cohort study with two non‐randomly assigned treatment arms and historical controls: DAM tablets only versus DAM tablets combined with injected DAM and/or other opioids, with an observation period of 1 year. Setting Twenty‐one out‐patient treatment centres of the Swiss heroin‐assisted treatment programme. Participants A total of 128 patients received DAM tablets only, and 237 patients received a combination of orally and intravenously applied DAM and other opioids. Measurements Retention rate after 1 year; number of serious adverse events; dosage of DAM over time; subjective tolerance of study medication. Findings In the intention‐to‐treat analysis, 1‐year retention rates after 1 year in the DAM tablets‐only group [0.804, 95% confidence interval (CI) = 0.735–0.873] as well as in the subgroup combining oral application of DAM with intravenous application or other opioids (0.843, 95% CI = 0.797–0.889) were higher compared to historical controls (Swiss cohort of patients who had been substituted intravenously with DAM; 1‐year retention rate = 0.70). Rates of serious adverse events under study medication (tablets only = 0.038 per application year; tablets in combination = 0.028 per application year) were comparable to the historical rate of the Swiss heroin‐assisted treatment (0.043). Conclusions DAM tablets seem to be an effective and safe application mode of heroin‐assisted substitution treatment. Randomized clinical trials to compare its relative efficacy to other substances are necessary.