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:

* 18 years of age or older
* Current opioid injector, at least weekly in the past month
* Current opioid dependence, SCID confirmed
* Currently receiving an inpatient buprenorphine detoxification protocol.

Exclusion Criteria:

* Patients unable to be interviewed due to acute illness or cognitive impairment
* In police custody, expecting incarceration
* Persons who cannot provide two contact persons (including shelters, parole officers, etc.) to verify location
* Not able to complete assessments in English
* Enrolled in a methadone maintenance program
* Plans to leave the area within the next 6 months.
B: Inclusion Criteria:

* Current opioid dependence
* Current buprenorphine detoxification
* 18-59 years of age
* English proficiency

Exclusion Criteria:

* Acute mania, psychosis, or suicidality
* Cognitive impairments precluding informed consent
* Heart disease or contraindicated heart condition
* Use of pace maker
* History of seizure disorder
* Current detoxification from alcohol or benzodiazepines
* Inability to return to follow-up visits
* For women, pregnancy
C: Inclusion Criteria:

* For inclusion in the proposed studies, subjects must be \> 18 years old and in good health. Subjects must meet DSM-IV criteria for opioid dependence and FDA qualification criteria for buprenorphine treatment, including a history of opioid dependence and significant current opioid use (i.e., opioid-positive urines). Subjects must also be seeking or willing to accept opioid detoxification.

Exclusion Criteria:

* Because the primary focus of the proposed research is to develop an efficacious intervention for prescription opioid abuse that employs a buprenorphine taper and subsequent naltrexone maintenance, individuals who require ongoing opioid therapy for pain or other chronic medical conditions will be excluded from participating.
* Individuals with evidence of an active psychiatric disorder that may interfere with consent or participation in the research (e.g., psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g., cardiovascular disease) or who are pregnant or nursing will be excluded from participation.
D: 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

Answer: D