A prospective cohort study on orally administered heroin substitution for severely addicted opioid users.
OBJECTIVE
To assess the efficacy and safety of orally administered heroin [diacetylmorphine (DAM)] tablets in substitution treatment of severely addicted opioid users.


METHODS
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.


METHODS
Twenty-one out-patient treatment centres of the Swiss heroin-assisted treatment programme.


METHODS
A total of 128 patients received DAM tablets only, and 237 patients received a combination of orally and intravenously applied DAM and other opioids.


METHODS
Retention rate after 1 year; number of serious adverse events; dosage of DAM over time; subjective tolerance of study medication.


RESULTS
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.
Frick
Ulrich
U
Research Institute for Addiction and Public Health, Zurich, Switzerland. ulrich.frick@isgf.unizh.ch
Rehm
Jürgen
J
Kovacic
Susanne
S
Ammann
Jeannine
J
Uchtenhagen
Ambros
A
D000328:Adult; D015331:Cohort Studies; D005260:Female; D003932:Heroin / Q000008:administration & dosage*; D006556:Heroin Dependence / Q000534:rehabilitation*; D006801:Humans; D008297:Male; D009294:Narcotics / Q000008:administration & dosage*; D011446:Prospective Studies; D015819:Substance Abuse, Intravenous / Q000534:rehabilitation*; D016896:Treatment Outcome
D009294:Narcotics; D003932:Heroin