Effectiveness of Alcohol Interventions Among Tuberculosis (TB) Patients in Tomsk Oblast, Russia

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.

Timeline

Start

2007-01

Primary completion

2011-06

Completion

2011-06

Publications

• Greene MC, Kane J, Alto M, Giusto A, Lovero K, Stockton M, McClendon J, Nicholson T, Wainberg ML, Johnson RM, Tol WA. Psychosocial and pharmacologic interventions to reduce harmful alcohol use in low- and middle-income countries. Cochrane Database Syst Rev. 2023 May 9;5(5):CD013350. doi: 10.1002/14651858.CD013350.pub2.
• Miller AC, Nelson AK, Livchits V, Greenfield SF, Yanova G, Yanov S, Connery HS, Atwood S, Lastimoso CS, Shin SS; Tomsk Tuberculosis Alcohol Working Group. Understanding HIV Risk Behavior among Tuberculosis Patients with Alcohol Use Disorders in Tomsk, Russian Federation. PLoS One. 2016 Feb 12;11(2):e0148910. doi: 10.1371/journal.pone.0148910. eCollection 2016.
• Connery H, Greenfield S, Livchits V, McGrady L, Patrick N, Lastimoso CS, Heney JH, Nelson AK, Shields A, Stepanova YP, Petrova LY, Anastasov OV, Novoseltseva OI, Shin SS. Training and fidelity monitoring of alcohol treatment interventions integrated into routine tuberculosis care in Tomsk, Russia: the IMPACT Effectiveness Trial. Subst Use Misuse. 2013 Jun;48(9):784-92. doi: 10.3109/10826084.2013.793715. Epub 2013 Jun 10.

Drugs

Indications