Research

Fresh Start along with The University of Western Australia (UWA) and Go Medical Industries Pty Ltd is continually doing research into improving medical treatments for addictions.

Naltrexone Research

As part of the process of registration of the implant, research has been done into the efficacy, biocompatibility and safety of the implant and the way the naltrexone is absorbed and moves through the body. Results from these studies have been published in a number of well-known academic journals.

A recently published study by UWA reports the results of a double blind, double-dummy randomised controlled trial of implant naltrexone vs oral naltrexone with follow up for 6 months and a pharmacokinetic study of naltrexone blood levels post-implant. The study showed that 88% of patients in the active implant group had not used heroin at 6 months compared with 33% of patients in the placebo implant group (active oral naltrexone). The implant was found to be well tolerated with generally only mild side effects often associated with oral naltrexone.

The proportion of users who did not return to regular heroin use on naltrexone implant and oral naltrexone

Opiates Research

A clinical study recently completed in Norway examined the efficacy of the naltrexone implant as compared to usual treatment. The study found that on average, over an 180 day period, subjects in the implant treatment group only used heroin on 17.9 days and opiates on 37 days, as compared with subject in the ‘usual care’ group who used heroin on average 64 day and opiates 97 days. In addition only 3 of 23 patients who completed 6 months of naltrexone implant treatment were still dependant on opiates, whereas 17 of 26 who completed 6 months of usual care were still dependant on opiates.

Amphetamine Research

A recent study conducted by Fresh Start’s amphetamine research group, investigating the effectiveness of the implant in amphetamine patients, found that following implantation 65% of patients stopped using for a period of time (greater than 3 months) and 30% reduced or gained control over their amphetamine use.

Abstinence in amphetamine dependent patients treated with naltrexone implants, conducted by Fresh Start

This data is supported by several large clinical trials conducted by the Karolinska Institute in Sweden using oral naltrexone. Their study showed that when compared with a placebo, oral naltrexone reduced patients ‘wanting more’, the ‘feel of the drug’ and the ‘overall high’ experienced for amphetamines. Their research also showed the number of consecutive negative urine tests was higher for patients treated with naltrexone (as compared with a placebo). At 24 weeks following the start of treatment approximately 35% of naltrexone patients had maintained negative urines for the duration of the study as compared with 7% in the placebo group.

Alcohol Research

The University of Western Australia and Fresh Start Recovery Programme are currently conducting research linked to the cost effectiveness of implanting patients with naltrexone, the health improvements of the patients and the burden on the public health system. As part of the research additional information is being gathered relating to the cessation of alcohol use, changes in drinking patterns and the satisfaction of patients with treatment.

Flumazenil Research

Currently, research is being conducted into the use of flumazenil for withdrawals from benzodiazepines both in Western Australia and Victoria by Professor Gary Hulse from UWA and Professor John Curry from St Vincent’s Hospital in Melbourne. A range of pilot studies regarding subcutaneous flumazenil infusions have been published as a result of their research.

The findings have demonstrated excellent results with few adverse reactions. For the majority of patients there is substantial reduction of withdrawal symptoms, and generally well tolerated treatment. Patients that have undergone flumazenil treatment have expressed a high level of satisfaction with the treatment.

Hepatitis C Research

A study done by the University of Western Australia, Sir Charles Gairdner Hospital and Fresh Start on patients who were treated for hepatitis C in the HCV Shared Care program at Fresh Start showed that 62% of them achieved an SVR after 6 months. This percentage is about the same as the results of hepatitis C treatment programs for the general population (mainly non-drug users) at specialist out-patient liver clinics.

Dr O’Neil has many publications about treatment for addictions.

Other studies

Around half (45%) of all patients treated with O’Neil implants at the Fresh Start Clinic have returned for a second treatment, and many patients continue to self-refer themselves to the clinic to assist with the management of their drug dependence. Fresh Start continues to collaborate with University of Western Australia to conduct research studies of outcomes in these populations. Some of these are described below.

Ultrasound Study

A cross-sectional ultrasound study was conducted within a group implant patients at varying times since implant treatment. The study results provided direct evidence of invivo reabsorption of the implant over time, and its biodegradability in humans.

Biopsy study

54 patients provided biopsy samples for histological characterization of the tissue surrounding the implant at varying stages of biodegradation. The study demonstrated that the subcutaneous insertion of the O’Neil Long Acting Naltrexone Implant is well tolerated by human subjects and is biocompatible. No significant histological events were noted.

For more links to Journal papers on the topics above, go to the Research Links page.