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A prospective cohort study on orally administered heroin substitution for severely addicted opioid users


Frick, Ulrich; Rehm, Jürgen; Kovacic, S; Ammann, J; Uchtenhagen, Ambros (2006). A prospective cohort study on orally administered heroin substitution for severely addicted opioid users. Addiction, 101(11):1631-1639.

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.

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.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > Swiss Research Institute for Public Health and Addiction
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:2006
Deposited On:20 May 2014 11:36
Last Modified:05 Apr 2016 17:51
Publisher:Wiley-Blackwell
ISSN:0965-2140
Publisher DOI:https://doi.org/10.1111/j.1360-0443.2006.01569.x
PubMed ID:17034443

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