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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborators: Harvard School of Public Health; Harvard School of Public Health (HSPH); Mclean Hospital
• Treatments: Ethanol; Naltrexone

Criteria

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.