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- Title
A prospective cohort study on orally administered heroin substitution for severely addicted opioid users.
- Authors
Frick, Ulrich; Rehm, Jürgen; Kovacic, Susanne; Ammann, Jeannine; Uchtenhagen, Ambros
- Abstract
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.
- Subjects
HEROIN; DRUG abuse treatment; OPIOID abuse; COHORT analysis; INTRAVENOUS injections; METHADONE treatment programs; ORAL medicine; DRUG tolerance; BUPRENORPHINE; THERAPEUTICS
- Publication
Addiction, 2006, Vol 101, Issue 11, p1631
- ISSN
0965-2140
- Publication type
Article
- DOI
10.1111/j.1360-0443.2006.01569.x