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| ID | Type | Description | Link |
|---|---|---|---|
| NIH 1 RO1 AA016318-01 |
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| Name | Class |
|---|---|
| Mclean Hospital | OTHER |
| Harvard School of Public Health (HSPH) | OTHER |
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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:
The specific aims of the pilot are:
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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Behavioral Counseling Intervention (BCI) plus treatment as usual (TAU) (i.e. standard referral to and management by an addictions specialist) |
|
| 2 | Experimental | Naltrexone/ Brief Behavioral Compliance Enhancement Treatment (BBCET) plus TAU |
|
| 3 | Experimental | BCI + Naltrexone/BBCET plus TAU |
|
| 4 | Active Comparator | Treatment as Usual (TAU) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Counseling Intervention (BCI) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol: change in mean number of heavy drinking days in last month of study period compared with baseline | 6 months | |
| TB: successful treatment vs. non-successful treatment as defined by the WHO | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to death | 6 months | |
| Nonadherence to TB therapy, defined as having taken less than 80% of indicated doses | 6 months | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sonya S Shin, MD, MPH | Division of Global Health Equity, Brigham and Women's Hospital; Harvard Medical School | Principal Investigator |
| Viktoriya Livchits, MD, MSc | Division of Global Health Equity, Brigham and Women's Hospital; Partners In Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tomsk Oblast TB Services | Tomsk | Tomsk Oblast | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37158538 | Derived | 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. | |
| 26871943 |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| C543522 | 2-benzylidene-3-(cyclohexylamino)-2,3-dihydro-1H-inden-1-one |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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|
| Naltrexone | Drug | 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. |
|
| BCI + Naltrexone | Other | Combination of the two previous interventions |
|
| Treatment as Usual | Behavioral | Services provided by psychologists and narcologists (additions specialists) employed by the Tomsk Oblast TB Services. |
|
| 6 months |
| 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 | 6 months |
| Change in mean Addiction Severity Index (ASI) alcohol scores at the end of the study period, compared with baseline | 6 months |
| 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. |
| 23750742 | Derived | 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. |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |