Effectiveness of Alcohol Interventions Among Tuberculosis (TB) Patients in Tomsk Oblast, Russia
NCT ID: NCT00675961
Last Updated: 2017-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
400 participants
INTERVENTIONAL
2007-01-31
2011-06-30
Brief Summary
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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.
Detailed Description
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1. 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.
2. 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.
3. 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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1
Behavioral Counseling Intervention (BCI) plus treatment as usual (TAU) (i.e. standard referral to and management by an addictions specialist)
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.
2
Naltrexone/ Brief Behavioral Compliance Enhancement Treatment (BBCET) plus TAU
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.
3
BCI + Naltrexone/BBCET plus TAU
BCI + Naltrexone
Combination of the two previous interventions
4
Treatment as Usual (TAU)
Treatment as Usual
Services provided by psychologists and narcologists (additions specialists) employed by the Tomsk Oblast TB Services.
Interventions
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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.
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.
BCI + Naltrexone
Combination of the two previous interventions
Treatment as Usual
Services provided by psychologists and narcologists (additions specialists) employed by the Tomsk Oblast TB Services.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Mclean Hospital
OTHER
Harvard School of Public Health (HSPH)
OTHER
Brigham and Women's Hospital
OTHER
Responsible Party
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Sonya Sunhi Shin
Associate Physician
Principal Investigators
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Sonya S Shin, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Division of Global Health Equity, Brigham and Women's Hospital; Harvard Medical School
Viktoriya Livchits, MD, MSc
Role: STUDY_DIRECTOR
Division of Global Health Equity, Brigham and Women's Hospital; Partners In Health
Locations
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Tomsk Oblast TB Services
Tomsk, Tomsk Oblast, Russia
Countries
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References
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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.
Other Identifiers
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NIH 1 RO1 AA016318-01
Identifier Type: -
Identifier Source: secondary_id
2005P-002539
Identifier Type: -
Identifier Source: org_study_id