Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effectiveness of Alcohol Interventions Among TB Patients in Tomsk Oblast, Russia
Brief Summary: The primary goal of this study is to assess the effectiveness of two alcohol interventions administered singly or in combination as an integrated component of TB care provided to patients with co-occurring TB and AUDs in Tomsk, Russia. Here we propose two parts of this study:

First, a pilot study to provide Naltrexone to TB patients will be conducted. If feasibility and safety are demonstrated, then we will conduct a randomized clinical trial (RCT) of the following four study arms:

1. A Behavioral Counseling Intervention (BCI) plus treatment as usual (TAU) (i.e. standard referral to and management by an addictions specialist);
2. Naltrexone/ Brief Behavioral Compliance Enhancement Treatment (BBCET) plus TAU
3. BCI + Naltrexone/BBCET plus TAU
4. TAU The RCT will be conducted only if Naltrexone use proves safe and feasible in the pilot study. However, because the pilot does not have a control group and nor is it a Phase I clinical trial, we define "safety" here as demonstration of appropriate adverse event management and adequate safety monitoring procedures, all of which will also be used in the RCT.

The specific aims of the pilot are:

1. To determine the feasibility of administering Naltrexone to patients receiving TB treatment, and
2. To assess the safety of administering Naltrexone to patients receiving TB treatment.

The investigators aim to test the following hypotheses for the pilot: co-administration of Naltrexone with TB treatment is feasible and safe in a population of TB patients with AUDs.

The specific aims of the RCT are:

1. To compare TB treatment outcomes among patients in each of the three intervention arms with the control arm of treatment as usual, and
2. To compare the change in mean number of heavy drinking days in last month of study period compared with baseline among patients in each of the three intervention arms with the control arm of treatment as usual.

The investigators aim to test the following hypotheses for the RCT: Individuals receiving one of the three interventions (Naltrexone, BCI or the combination of Naltrexone/BCI) will experience better TB outcomes and a greater change in the mean number of heavy drinking days, compared with individuals receiving treatment as usual.


Options:
A: Inclusion Criteria:

* Burmese national, 18 or over, living in Thailand outside of refugee camps, meets or exceed the algorithm for the Hopkins Symptoms Checklist 25 (HSCL-25) depression subscale and/or the algorithm for the Harvard Trauma Questionnaire (HTQ) posttraumatic stress scale.

Exclusion Criteria:

* not Burmese national, under 18, not living in Thailand outside of refugee camps, does not meet meet or exceed the algorithm for the Hopkins Symptoms Checklist 25 (HSCL-25) depression subscale and/or the algorithm for the Harvard Trauma Questionnaire (HTQ) posttraumatic stress scale; active psychosis
B: Inclusion Criteria:

* Men and women older than 18 years and 50 years
* Achieving a moderate risk score in the ASSIST screening questionnaire.
* Without any similar intervention in the last 3 months. (ie. AUDIT test).

Exclusion Criteria:

* Pregnant women.
* Users with cognitive disabilities.
* Users with language and communication disabilities.
C: Inclusion Criteria:

* HIV-infected adult (≥18 years) prescribed antiretroviral therapy (ART) for at least 6 months;
* Current heavy alcohol use (AUDIT-C positive for prior 3 month drinking and positive EtG urine test);
* Positive tuberculin skin test (TST) (≥5 mm induration);
* AST and ALT \<2x the upper limit of normal (ULN);
* Fluent in Runyankole or English;
* No history of active TB, TB treatment, or TB preventive therapy;
* Lives within 2-hour travel time or 60 km of the study site.

Exclusion Criteria:

* Prescribed nevirapine (NVP, an ART drug that is declining in usage due to high risk for hepatotoxicity);
* Plans to move out of the catchment area within 6 months;
* Prescribed anti-convulsion medications or history of recurring seizures;
* ALT or AST elevations (\>2X ULN);
* Suspected or confirmed active TB as determined by symptom screening and followed by chest X-ray and sputum testing;
* History of prior active TB treatment or prior IPT.
* Pregnant at time of screening
D: Inclusion Criteria:

* Are newly diagnosed with Pulmonary TB: infiltrative, disseminated, or other forms of TB in phase of disintegration
* Will initiate TB treatment in one of 7 study sites (Tomsk Oblast TB Hospital, polyclinic, day hospital, and raions)
* Are 18 years and older
* Are diagnosed with alcohol abuse and dependence by the CIDI-SAM; and
* Signed informed consent

Exclusion Criteria:

* Have liver function tests more than 3x the upper limit of normal range. The participant can be retested after 5 days; if any of the repeat liver function tests is more than 3x upper limit of normal range, the person is excluded
* Reported opioid use in the past month or positive during screen for opioids. The participant can be retested after 5 days; if the second urine screen is positive, the person is excluded;
* Are pregnant or breastfeeding;
* Demonstrate inadequate understanding of the study after undergoing informed consent; or
* Have any co-occurring other medical or psychiatric condition that would make it impossible for them to comply with the study procedures.

Answer: D