Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Two-Phase Randomized Controlled Clinical Trial of Buprenorphine/Naloxone Treatment Plus Standard Medical Management or Enhanced Medical Management for Opioid Analgesic Dependence
Brief Summary: The purpose of this study is to determine whether treatment outcome for subjects dependent on prescription opioid analgesics can be improved by adding individual drug counseling to the prescription of buprenorphine/naloxone with standard medical management. This will be examined during: a) an initial four-week treatment with taper; b) a 12-week stabilization treatment for those who do not respond successfully to the initial treatment; and c) a long-term follow-up assessment at 1.5 years, 2.5 years, and 3.5 years after treatment.


Options:
A: Inclusion Criteria:

1. Were age 18 years or older,
2. Met DSM-IV-TR criteria for opioid dependence,
3. Were in good general health, or, in case of a medical/psychiatric condition requiring ongoing treatment, were under the care of a physician willing to continue participant's medical management and cooperate with study physicians,
4. For female participants, use of one of the following acceptable methods of birth control:

   1. oral contraceptives
   2. barrier (diaphragm or condom) with spermicide
   3. IUD
   4. intrauterine progesterone contraceptive system
   5. levonorgestrel implant
   6. medroxyprogesterone acetate contraceptive injection
   7. contraceptive transdermal patch
   8. hormonal vaginal contraceptive ring
   9. surgical sterilization
   10. complete abstinence from sexual intercourse
5. Able to read and verbalize understanding of the study and voluntarily sign study informed consent form.

Exclusion Criteria:

1. ALT or AST values \> 5 times the upper limit of normal as per testing laboratory range criteria,
2. ALP values \>3 times the upper limit of normal per testing laboratory criteria,
3. Any documented past or present history of ascites, presence of esophageal or gastric varices, hepatic encephalopathy or other signs of significant liver disease as indicated by a Model for Endstage Liver Disease score (Kamath et al., 2001) of ≥11,
4. Total bilirubin \> 2.0 mg/dl (participants with documented Gilbert's syndrome were not excluded based on this criterion),
5. Prothrombin time more than 3 seconds prolonged,
6. Albumin level less than 2.5 g/dl,
7. Any cardiopathy or risk factor listed below without evidence of a normal ECG\* with report performed within 6 months prior to first study medication dose,

   1. Congestive heart failure
   2. Left ventricular hypertrophy
   3. Bradycardia
   4. Hereditary QT prolongation
   5. Uncorrected electrolyte imbalance
   6. Concomitant medications that are known to have a risk of QT interval prolongation; refer to Appendix D for a list of medications.

   Note: The list was not all-inclusive.

   \*An ECG was abnormal if one or more of the following occurred:

   Significant ST segment abnormalities:
   * ST segment elevations in two or more continuous leads of \> 0.1 mV
   * ST segment depression of greater than 1 mm that are flat or down-sloping at 80 msec after the J point ST segment abnormalities identified as "non-specific" are acceptable. If a potential participant's ECG indicated ST segment elevations or depression consistent with ischemia, the physician obtained a medical history of cardiac symptoms and referred the participant for evaluation.

   Conduction abnormalities:
   * Mobitz II 2nd degree or 3rd degree heart block
   * Atrial fibrillation, atrial flutter, or any non-sinus tachyarrhythmia
   * Three or more consecutive ectopic ventricular complexes at a rate of \> 100 per minute.
   * QTc greater than 450 msec in men and 480 msec in women

   Repolarization abnormalities:

   • Acute medical condition that would make participation, in the opinion of the study physician, medically hazardous (e.g., unstable pancreatic, cardiovascular or renal disease, significant anemia)
8. Known allergy or sensitivity to BUP, naloxone or MET or to any of the inactive ingredients in the study medications (including lactose, mannitol, cornstarch, povidone K30, citric acid, sodium citrate, FD\&C Yellow No.6 color, magnesium stearate, Acesulfame K sweetener)
9. Known diagnosis of acute psychosis, severe depression or imminent suicide risk as determined via clinical interview by study physician or surrogates
10. DSM-IV diagnosis of dependence on alcohol requiring immediate medical attention.
11. DSM-IV diagnosis of dependence on benzodiazepines requiring immediate medical attention
12. DSM-IV diagnosis of dependence on other depressants, or stimulants requiring immediate medical attention
13. Participation in an investigational drug study within the past 30 days
14. Treatment with MET, BUP/NX, or BUP for more than 15 of the past 30 days (illicit use of these medications is allowed)
15. Pending legal action that could prohibit study participation
16. Unable or unwilling to comply with study requirements
17. Unable or unwilling to remain in the local area for duration of treatment
18. Poor venous access such that venipuncture could not be accomplished from a vein in an extremity during eligibility
19. Pregnant or lactating (females only)
B: 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.
C: 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
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: C