Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Placebo and Active-Controlled, Multi-Center Study of Probuphine in Patients With Opioid Dependence
Brief Summary: Probuphine (buprenorphine implant) is an implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This study will confirm the efficacy of Probuphine vs. placebo and compare Probuphine treatment verses treatment with sublingual buprenorphine in the treatment of patients with opioid dependence.


Options:
A: Inclusion Criteria

* Male or female
* 18 years of age and older
* Meet DSM-5 criteria for opioid-use disorder (heroin and/or prescription opioids)
* Have used opioids other than as specifically prescribed within thirty days prior to consent
* Seeking treatment for opioid dependence and willing to accept "agonist-based" or "antagonist-based" therapy
* In good-enough general health, as determined by the study physician on the basis of medical history, review of systems, physical exam and laboratory assessments, to permit treatment with XR-NTX or BUP-NX
* Able to provide written informed consent
* Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study
* If female of childbearing potential, be willing to practice an effective method of birth control for the duration of participation in the study

Exclusion Criteria

* Serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make study participation hazardous to the participant, or compromise study findings or would prevent the participant from completing the study. Examples include:

  1. Disabling or terminal medical illness (e.g., uncompensated heart failure, cirrhosis or end-stage liver disease) as assessed by medical history, review of systems, physical exam and/or laboratory assessments;
  2. Severe, untreated or inadequately treated mental disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and/or clinical interview;
  3. Current severe alcohol, benzodiazepine, or other depressant or sedative hypnotic use likely to require a complicated medical detoxification (routine alcohol and sedative detoxifications may be included)
* LFTs (ALT, AST) greater than 5 times upper limit of normal
* Suicidal or homicidal ideation that requires immediate attention
* Known allergy or sensitivity to buprenorphine, naloxone, naltrexone, polylactide-co-glycolide, carboxymethylcellulose, or other components of the Vivitrol® diluent
* Maintenance on methadone at doses of 30mg or greater at the time of signing consent
* Presence of pain of sufficient severity as to require ongoing pain management with opioids
* Pending legal action or other reasons that might prevent an individual from completing the study
* If female, currently pregnant or breastfeeding, or planning on conception
* Body habitus that, in the judgment of the study physician, precludes safe intramuscular injection of XR-NTX (e.g., BMI\>40, excess fat tissue over the buttocks, emaciation)
B: Inclusion Criteria:

* Voluntarily provide written informed consent prior to the conduct of any study-related procedures
* Male or female, 18-65 years of age
* Meet DSM-IV-TR criteria for current opioid dependence
* Females of childbearing potential or a fertile male, must use a reliable means of contraception

Exclusion Criteria:

* Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS)
* Received any medication-assisted treatment for opioid dependence (e.g., methadone, BPN) within the previous 90 days
* Current diagnosis of chronic pain requiring opioids for treatment
* Candidates for short-term opioid treatment (\<6 months) only, or opioid detoxification therapy
* Pregnant or lactating female?
* Previous hypersensitivity or allergy to BPN, EVA-containing substances, or naloxone
* Current use of agents metabolized through Cytochrome P450 3A4 (CYP 3A4) such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), or protease inhibitors (e.g., ritonavir, indinavir, and saquinavir)
* History of coagulopathy within the past 90 days, and/or current anti-coagulant therapy such as warfarin
* Meet the DSM-IV-TR criteria for dependence on any other psychoactive substances other than opioids or nicotine (e.g., alcohol, sedatives)
* Significant medical or psychiatric symptoms, cognitive impairment, or other factors which in the opinion of the Investigator would preclude compliance with the protocol, subject safety, adequate cooperation in the study, or obtaining informed consent
* Current medical conditions such as severe respiratory insufficiency that may prevent the subject from safely participating in study, or any pending legal action that could prohibit participation or compliance in the study
* Exposure to any investigational drug within the previous 8 weeks
* Previous exposure to Probuphine, or prior implantation with a placebo implant in the context of a Probuphine clinical trial
* Presence of aspartate aminotransferase (AST) levels greater than or equal to 3 X the upper limit of normal, alanine aminotransferase (ALT) levels greater than or equal to 3 X the upper limit of normal, total bilirubin greater than or equal to 1.5 X the upper limit of normal, or creatinine greater than 1.5 X upper limit of normal on the screening laboratory assessments
* Clinically significant low platelet count on the screening laboratory assessments
C: Inclusion Criteria:

1. have a well-documented chronic pain disorder due to past back surgery,
2. have a chronic back pain syndrome,
3. have evidence of opioid addiction,
4. prior attempt at abstinence-oriented treatment documented by the referring physician,
5. be able to understand spoken and written English,
6. reside in Erie or Niagara counties,
7. have health insurance or other ability to pay for treatment with the approval from patient's primary physician;
8. have no prior history of methadone or BUP/NLX maintenance treatment since the last surgery,
9. not be a member of a vulnerable population, including prisoners

Exclusion Criteria:

1. homeless, or any patient without a "locator" (no means to participate in the follow-up data collection interviews by phone),
2. inability to give consent,
3. those with major co-occurring psychiatric disorders,
4. EKG showing prolonged QT and/or previous cardiac issues,
5. are taking a medication that is contraindicated with methadone,
6. medically unstable,
7. urine positive for cocaine at initial visit,
8. pregnant women
D: Inclusion Criteria:

* HIV-infected
* Clinical Diagnosis of Opioid Dependence
* Fluent in Bahasa Malaysia or English
* Within 90 to 180 days of release from prison
* Planning to live in Klang Valley region after release from prison
* Able to provide informed consent

Exclusion Criteria:

* Pregnancy or planning to become pregnant (female only)

Answer: B