Tomsk Oblast TB Services
Tomsk, Tomsk Oblast, Russia
NCT Number: NCT00675961
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Tomsk, Tomsk Oblast, Russia
An important aspect of the delivery of these alcohol interventions will be their incorporation into TB care and delivery by non-alcohol specialists, i.e. TB physicians. In this study, we propose to exploit the strengths of the TB care delivery paradigm (DOTS) by linking to this care system the provision of alcohol interventions. In order to develop this integrated system, we propose the following innovative approaches to AUD management among TB patients:
To our knowledge, this is the first study to examine the feasibility of alcohol care when delivered as part of routine TB care and to assess this treatment model's impact on both TB and alcohol outcomes. If proven feasible and effective, this treatment model could be adapted for patients with AUDs and co-occurring medical conditions in other settings. First, this model could be used anywhere co-occurring AUDs adversely affect TB outcomes, including the United States. Second, this strategy could integrate alcohol treatment with medical care of other chronic conditions that are affected by poor adherence due to alcohol use. In particular, the greatest global challenge to treating HIV infection in populations with high rates of substance use is the successful management of substance use to ensure adherence to antiretroviral therapy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Two-tiered BCI characterized by both primary and secondary interventions. Primary BCI treatment format consists of 6 discussions delivered monthly in the first 6 months of standard TB treatment. 10-15 minutes long. Secondary BCI is delivered on a monthly basis while receiving TB treatment. 5-10 minutes long.
Opioid antagonist, which decreases the pleasurable response to and craving for alcohol consumption. Oral; single daily dose of 50 mg per day for 6 months.
Combination of the two previous interventions
Services provided by psychologists and narcologists (additions specialists) employed by the Tomsk Oblast TB Services.
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Brigham and Women's Hospital
Other
Effectiveness of Alcohol Interventions Among TB Patients in Tomsk Oblast, Russia
Acronym: IMPACT
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