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:
- A Behavioral Counseling Intervention (BCI) plus treatment as usual (TAU) (i.e. standard referral to and management by an addictions specialist);
- Naltrexone/ Brief Behavioral Compliance Enhancement Treatment (BBCET) plus TAU
- BCI + Naltrexone/BBCET plus TAU
- 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:
- To determine the feasibility of administering Naltrexone to patients receiving TB treatment, and
- To assess the safety of administering Naltrexone to patients receiving TB treatment.
We 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:
- To compare TB treatment outcomes among patients in each of the three intervention arms with the control arm of treatment as usual, and
- 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.
We 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.
Primary Outcome Measures:
- Alcohol: change in mean number of heavy drinking days in last month of study period compared with baseline [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- TB: successful treatment vs. non-successful treatment as defined by the WHO [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Time to death [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Nonadherence to TB therapy, defined as having taken less than 80% of indicated doses [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Acquisition of drug resistance, defined as new resistance confirmed by DST performed during the study period (compared with baseline DST) to any TB drug to which the subject was exposed during the study [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in the mean number of heavy drinking days (defined as 4 drinks per drinking day for women and 5 drinks per drinking day for men) in the last month of the study compared with baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in mean Addiction Severity Index (ASI) alcohol scores at the end of the study period, compared with baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: |
380 |
| Study Start Date: |
January 2007 |
| Estimated Study Completion Date: |
June 2009 |
| Estimated Primary Completion Date: |
February 2009 (Final data collection date for primary outcome measure) |
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1: Experimental
Behavioral Counseling Intervention (BCI) plus treatment as usual (TAU) (i.e. standard referral to and management by an addictions specialist)
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Behavioral: Brief Counseling Intervention (BCI)
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.
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2: Experimental
Naltrexone/ Brief Behavioral Compliance Enhancement Treatment (BBCET) plus TAU
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Drug: Naltrexone
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.
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3: Experimental
BCI + Naltrexone/BBCET plus TAU
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Other: BCI + Naltrexone
Combination of the two previous interventions
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4: Active Comparator
Treatment as Usual (TAU)
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Behavioral: Treatment as Usual
Services provided by psychologists and narcologists (additions specialists) employed by the Tomsk Oblast TB Services.
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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:
- The Behavioral Counseling Intervention (BCI) will be adapted through iterative collaboration of an interdisciplinary team of local and international specialists to derive a protocol that is easily integrated into routine patient care by TB physicians. This process will include assessment for feasibility and cultural acceptability within the Tomsk clinic and the evaluation of TB physicians for adherence to the BCI protocol.
- Secondary interventions, incentives and case management, will be implemented to maximize the primary BCI intervention delivered by the TB physician and increase patient motivation to change drinking behavior. These will be designed to capitalize on similar case holding strategies already in place in the Tomsk TB services.
- Naltrexone will be delivered in the context of DOTS, administered under direct observation administration along with TB medications.
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.
Purpose
