Please select the eligibility criteria that correspond to the clinical trial below.
Title: HIV Risk Reduction and Drug Abuse Treatment in Malaysia
Brief Summary: A randomized clinical trial comparing drug abuse and HIV risk reduction counseling (DC-HIV) alone, DC-HIV combined with naltrexone maintenance, and DC-HIV combined with buprenorphine maintenance for the treatment of heroin addicts in Malaysia.


Options:
A: Inclusion Criteria:

* Current opioid dependence
* Current opioid use, as determined by a urine drug test
* Pregnant with a single child with a gestational age of 6 to 30 weeks, as determined by a sonogram

Exclusion Criteria:

* Current medical condition that would make study participation dangerous, as determined by study physician
* Diagnosed with an acute, severe psychiatric illness
* Current SCID I-E module diagnosis of benzodiazepine or alcohol abuse
* Use of alcohol or benzodiazepines in the 30 days prior to study entry, as determined by the Addiction Severity Index
* Pending legal action that may prohibit or interfere with study participation
B: Inclusion Criteria:

* Opioid dependence

Exclusion Criteria:

* Dependence on alcohol, benzodiazepines or sedatives
* Suicide or homicide risk
* Psychotic disorder or major depression
* Inability to read or understand the protocol or assessment questions
* Life-threatening or unstable medical problems
* Greater than 3 times normal liver enzymes (AST, GGT)
C: 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
D: Inclusion Criteria:

* HIV-infected and receiving continuity care in the Johns Hopkins HIV Clinic
* 18 years of age or older
* Meets DSM-IV criteria for opioid dependence
* Seeks agonist-based treatment for opioid dependence
* Willing and able to provide written informed consent
* Willing to be contacted by mail and telephone for study follow-up visit reminders
* Willing to authorize release of information for substance abuse treatment to the study for a period of 12 months
* If female, negative urine pregnancy test and willingness to practice birth control while on study if sexually active (barrier method or progesterone-containing contraception product)
* Verbal approval from participant's primary HIV clinician

Exclusion Criteria:

* Currently receiving methadone, naloxone, buprenorphine, or levomethadyl acetate (LAAM) as part of a licensed opioid treatment program
* History of allergic reaction to buprenorphine or naloxone
* Active medical need for opioid-based pain control
* Active benzodiazepine abuse or dependence
* Active alcohol dependence
* Alanine aminotransferase level that is more than 5 times the upper limit of normal
* Other condition that, in the opinion of the principal investigator, makes participation in the study unsafe or follow-up highly unlikely

Answer: B