Selective trial; heroin using males and females.
Community; individuals who presented for detoxification at the Australian Medical Research Procedures Foundation, Perth, Australia were sequentially recruited into the study.
Following opiate detoxification, the patients were instructed to take Naltrexone at a set dosage orally. Daily administration was the responsibility of the client's 'carer'.
Cessation of Naltrexone was reported back to the clinic by the carer. Staff would immediately follow-up study participants via peer-based networks and encourage re-entry to Naltrexone maintenance, providing prompt detoxification if necessary. There was ongoing counselling available to the participant and carer.
Daily.
The carer (often a family member) provided support for the participant to continue in the program as well as supervising daily Naltrexone. Initial training was provided to carers to first, ensure that they would effectively monitor daily oral Naltrexone use and secondly, to ensure that vigilance of supervision was maintained over time.
The minimum age for participation was 17 years and the maximum age was 47 years. The mean age was 26 years [SD ± 7 years] [47% were aged 22 or less].
A majority was still on Naltrexone six months after beginning the program, although a number of these individuals had returned to heroin use at least once during the trial.
Vigilance of daily supervision of Naltrexone by 'carers' over the first six weeks of treatment is a predictor of improved prognosis at six months.
The criteria for this trial resulted in a very young group of participants. The authors indicated that their young chronological age and limited time involved in heroin use could have had an impact on the outcome of the trial. In the discussion they note that the high success rate would have been significantly reduced if a casual return to heroin was considered a criteria for patient failure. Other clinical trials did not make such adjustments and appear to have a much lower success rate.
There was no differentiation in the results between age and success rate, so it is difficult to determine if this regime would be more successful with drug using youth. The study suggested the need for a broader review examining how relationships, employment and other psychosocial factors might affect the outcome.
The trial incorporated some best practice principles, as it experienced an improved prognosis by developing the skills of the 'carers', and through peer dispensing of the medication and daily supervision of the clients.
1997-1998.
The association between Naltrexone compliance and daily supervision. (2000); Hulse & Basso.
Reassessing Naltrexone maintenance as a treatment for illicit heroine users. (1999); Hulse and Basso.