Please select the arm or intervention descriptions that belong 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: Arm Label: Waitlist-Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Common Elements Treatment Approach; Type: EXPERIMENTAL; Interventions: Behavioral: Common Elements Treatment Approach | Intervention Type: BEHAVIORAL; Name: Common Elements Treatment Approach; Assigned to Arm(s): Common Elements Treatment Approach
B: Arm Label: Control group; Type: PLACEBO_COMPARATOR; Interventions: Other: Observation | Arm Label: Intervention group; Type: ACTIVE_COMPARATOR; Interventions: Other: ASSIST-linked brief intervention for hazardous and harmful substance use. | Intervention Type: OTHER; Name: ASSIST-linked brief intervention for hazardous and harmful substance use.; Assigned to Arm(s): Intervention group | Intervention Type: OTHER; Name: Observation; Assigned to Arm(s): Control group
C: Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Escalating incentives (EtG tests); Type: EXPERIMENTAL; Interventions: Behavioral: Incentives for negative EtG test | Arm Label: Escalating incentives (IsoScreen tests); Type: EXPERIMENTAL; Interventions: Behavioral: Incentives for positive IsoScreen test | Arm Label: Escalating incentives (EtG + IsoScreen); Type: EXPERIMENTAL; Interventions: Behavioral: Incentives for negative EtG test, Behavioral: Incentives for positive IsoScreen test | Intervention Type: BEHAVIORAL; Name: Incentives for negative EtG test; Assigned to Arm(s): Escalating incentives (EtG + IsoScreen), Escalating incentives (EtG tests) | Intervention Type: BEHAVIORAL; Name: Incentives for positive IsoScreen test; Assigned to Arm(s): Escalating incentives (EtG + IsoScreen), Escalating incentives (IsoScreen tests)
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Brief Counseling Intervention (BCI) | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Naltrexone | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Other: BCI + Naltrexone | Arm Label: 4; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Treatment as Usual | Intervention Type: BEHAVIORAL; Name: Brief Counseling Intervention (BCI); Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Naltrexone; Assigned to Arm(s): 2 | Intervention Type: OTHER; Name: BCI + Naltrexone; Assigned to Arm(s): 3 | Intervention Type: BEHAVIORAL; Name: Treatment as Usual; Assigned to Arm(s): 4

Answer: D