Back to search

BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering

Preventing opioid relapse and - overdose following discharge from detoxification or imprisonment - a multi-centre RCT

Awarded: NOK 6.4 mill.

Opioid dependence is associated with greatly increased risk of death compared to normal population. As detoxification reduces patients` tolerance to heroin and other opioids, discharge from prison or abstinence ?oriented inpatient treatment represents high-risk situation for overdose and ?death. The primary purpose of the project is to assess existing and novel strategies to prevent overdose. This will be done by comparing the outcomes of opioid dependent study participants who are discharged from prison or institutional settings in Norway in a)either a limited study follow-up without RCT or b)participants who are randomly allocated to oral buprenorphine-naloxone or sustained naltrexone before discharge. Biometric assessments, self-report and registry data will be collected and used to assess group differences on substance use and social adjustment outcomes. Following a 3-month RCT phase, patients will be allowed to continue, commence or switch study medication in a nine-month post-RCT phase. The study succeeded in recruiting an adequate number of participants and the last patient will finish the study in May 2016. Medication-assisted abstinence represents a novel aspect in the treatment of opioid dependence. Due to the nature of the study, our findings may have influence the development of future treatment strategies in this field of medicine.

Opioid dependence is associated with greatly increased risk of death compared to the normal population. As detoxification reduces patients' tolerance to heroin and other opioids, discharge from prison or abstinence-oriented inpatient treatment represents high-risk situations for overdose and - death. The primary purpose of the project is to assess existing and novel strategies to prevent overdose. This will be done by comparing the outcomes of opioid dependent study participants who are discharged from p rison or institutional settings in Norway in either a) a limited study follow-up without RCT participation or b) participants who are randomly allocated to oral buprenorphine-naloxone or sustained release naltrexone before discharge. Biometric, self-rep ort, and registry data will be collected and used to assess group differences on substance use and social adjustment outcomes. Following a 3-month RCT phase, patients will be allowed to continue, commence or switch study medication in a 9-month post-RCT p hase. The hypotheses are that the pharmacotherapy groups will do significantly better (p<.05) than the volunteer non-pharmacotherapy group on relapse and mortality, and that drop-out early in treatment will lead buprenorphine patients to have higher rates of relapse than naltrexone patients. As the study will emphasize generalizability in inclusion/exclusion criteria, the main challenges are anticipated to be recruitment and retention of patients. Due to the clinical nature of the study, the findings may have direct impact on the application and adoption of a new form of treatment for opioid dependence (sustained release naltrexone).

Funding scheme:

BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering