Please select the eligibility criteria that correspond to the clinical trial below.
Title: Optimal Prevention of Overdose Deaths and Opioid Relapse Following Discharge: A Multi-Center RCT of Naltrexone Versus Buprenorphine in Norway
Brief 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.


Options:
A: Inclusion Criteria:

* opiate or alcohol use disorder
* not currently in substance use disorder treatment
* past 30 day use of alcohol or opioids
* English or Spanish speaking

Exclusion Criteria:

* co-morbid severe mental illness
* medically unstable
B: 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
C: Inclusion Criteria:

* Females are not pregnant or lactating
* Subjects meet DSM-IV criteria for opiate dependence, are medically and psychiatrically stable, and do not have a current history of benzodiazepine dependence abuse, dependence, or treatment
D: Inclusion Criteria:

* 18 years old or older
* Physically dependent on opioids
* Meet DSM-IV criteria for opioid dependence

Exclusion Criteria:

* Known allergy or sensitivity to buprenorphine or naloxone
* Unstable psychiatric disorder
* Pregnant or lactating females
* Liver function test results greater than 5 times the upper limit of normal range

Answer: B