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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01717963
Other study ID # 2011-002858-31
Secondary ID 204725-1
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2012
Est. completion date April 30, 2018

Study information

Verified date October 2018
Source University of Oslo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Persons dependent on opioids like heroin, morphine, or codeine have a high risk of relapse, overdose and overdose death. This risk is elevated even further following discharge from treatment or correctional institutions where patients have been detoxified. At the moment, state-of-the-art treatment is based on maintaining the dependence on opioids by daily intake of opioid medications like methadone or buprenorphine. Recently, a medication containing the blocking agent naltrexone was approved in the US; this does not maintain dependence but instead blocks heroin and other opioids for 28 days after intramuscular administration. This study will conduct a 12-week randomized comparison of naltrexone intramuscular suspension (XL-NTX) with daily buprenorphine-naloxone in OMT. Medication will start preceding discharge from a treatment or correctional facility to participating catchment regions in Norway. The main hypotheses are that XL-NTX will do equally well as - or better than - OMT on the proportion of biological samples negative for opioids, retention, self-reported use of alcohol and illicit drugs. Following the 12-week randomized period, there will be a 36-week period where participants can receive the study medication of their choice. After the end of the study, data from national registry databases can be collected for a further 12 months on outcomes such as recidivism, mortality and morbidity.


Recruitment information / eligibility

Status Completed
Enrollment 166
Est. completion date April 30, 2018
Est. primary completion date August 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Opioid dependence (DSM-IV TR)

- Age 18 or above

- Applied & Approved for Norway's national OMT program

- Discharge within 30 days of inclusion from a controlled environment; e.g. inpatient treatment or correctional (prison) facility

- Voluntarily seeking treatment for opioid dependence

Exclusion Criteria:

- Pregnant or breast-feeding

- Acute or recurring severe psychiatric disorder, e.g. psychosis, suicidality

- Serious debilitation of liver or renal function (e.g. Child-Pugh level C)

- Use of excluded medication

- Known intolerance to study drugs or their ingredients

- Employment in firm manufacturing one of the study drugs or close relation to such person

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Naltrexone intramuscular suspension
A standard dosage of 380 mg / month of naltrexone intramuscular suspension will be administered
Buprenorphine-naloxone
Buprenorphine-naloxone is administered daily and provided in accordance with existing guidelines for OMT in Norway (treatment-as-usual).

Locations

Country Name City State
Norway Haukeland University Hospital Bergen Hordaland
Norway Akershus University Hospital Oslo Akershus
Norway Oslo University Hospital, Avdeling for Rus og Avhengighet Oslo
Norway Stavanger University Hospital Stavanger Rogaland
Norway Vestfold Hospital Trust Tonsberg Vestfold

Sponsors (10)

Lead Sponsor Collaborator
University of Oslo Haukeland University Hospital, Helse Stavanger HF, Norwegian Institute of Public Health, Oslo University Hospital, Ostfold Hospital Trust, The Hospital of Vestfold, The Research Council of Norway, The Royal Norwegian Ministry of Health, University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of biological samples negative/positive for opioid agonists Week 1-12 post discharge
Primary Retention Week 1-12 post discharge
Primary Days of use or abstinence from opioids Week 1-12 post discharge
Secondary Use of other substances of abuse Week 1-48
Secondary Mental health Self-reported mental health Week 1-12 or 1-48
Secondary Somatic health Self-reported and/or assessed by study personnel Week 1-12 or 1-48 post discharge
Secondary Psychosocial problems Psychosocial problems like recidivism, employment, family problems. Self-reported or registry-based. Week 1-12, Week 1-48, & Wk 49-100
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