Please select the eligibility criteria that correspond to the clinical trial below.
Title: START Follow-up Study (NIDA CTN Protocol 0050)
Brief Summary: The purpose of the study is to conduct a follow-up of substance abuse patients (n=1,269) about 2 to 5 years since they were originally recruited from 8 substance abuse treatment clinics (located in 5 states) to participate in a prior clinical trial study called "START" (Starting Treatment with Agonist Replacement Therapies). The START Follow-up Study will be conducted over 5 years and will involve three follow-up interviews with START participants.

The specific aims of the START Follow-up Study are as follows.

1. To determine longer-term outcomes of Suboxone versus methadone treatment received in the START
2. To investigate patient and treatment factors associated with post-START treatment access, utilization, and outcomes among Suboxone and methadone patients
3. To explore other correlates of the long-term outcomes among START patients.


Options:
A: 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 criteria for current opioid dependence
* Females of childbearing potential and fertile males must use a reliable means of contraception

Exclusion Criteria:

* Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS)
* Presence of aspartate aminotransferase (AST) levels ≥ 3 X upper limit of normal and/or alanine aminotransferase (ALT) levels ≥ 3 X upper limit of normal and/or total bilirubin ≥ 1.5 X upper limit of normal and/or creatinine ≥ 1.5 X upper limit of normal
* Received treatment for opioid dependence (e.g., methadone, BPN), within the previous 90 days
* Current diagnosis of chronic pain requiring opioids for treatment
* Candidates for only short term opioid treatment or opioid detoxification therapy
* Pregnant or lactating females
* Previous hypersensitivity or allergy to BPN- or EVA-containing substances or naloxone
* Current use of agents metabolized through CYP 3A4 such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), and protease inhibitors (e.g., ritonavir, indinavir, and saquinavir)
* Current anti-coagulant therapy (such as warfarin) or an INR \> 1.2
* Meet DSM-IV criteria for current dependence on any other psychoactive substances other than opioids or nicotine (e.g., alcohol, sedatives)
* Current use of benzodiazepines other than physician prescribed use
* Significant medical or psychiatric symptoms or dementia which in the opinion of the Investigators would preclude compliance with the protocol, patient safety, adequate cooperation in the study, or obtaining informed consent
* Concurrent medical conditions (such as severe respiratory insufficiency) that may prevent the patient from safely participating in study; and/or any pending legal action that could prohibit participation and/or compliance in study
* Participated in a clinical study within the previous 8 weeks
B: Inclusion Criteria:

* opioid dependence

Exclusion Criteria:

* current dependence on alcohol, cocaine, benzodiazepines or sedatives
* current suicide or homicide risk
* current psychotic disorder or untreated major depression
* inability to read or understand English
* life-threatening or unstable medical problems
C: Inclusion Criteria:

* To be eligible to participate in the study, individuals must have participated in CTN-0027 START.
D: Inclusion Criteria:

* For inclusion in the trial, participants must be \>18 years old, in good health, meet DSM-IV criteria for opioid dependence, provide an opioid-positive urine and be currently waitlisted.
* To minimize disruption due to treatment becoming available during the study, we will limit enrollment to those who joined a waitlist in the prior 12 months.

Exclusion Criteria:

* Those with a significant psychiatric or medical illness that may interfere with consent or participation will be excluded, as will those who are pregnant or nursing.
* Females will be tested for pregnancy and, should a participant become pregnant during the trial, her participation will be terminated and she will be assisted with accessing treatment at the high-risk pregnancy clinic.
* Those dependent on sedative-hypnotics will be excluded, due to the medical risks and notably low success rates with sedative-dependent opioid abusers (Stitzer \& Chutuape, 1999).

Answer: C