TuberculosisIMPACTNCT00675961
Effectiveness of Alcohol Interventions Among Tuberculosis (TB) Patients in Tomsk Oblast, Russia
A study testing Brief Counseling Intervention (BCI), Naltrexone and BCI + Naltrexone in people with Tuberculosis and Alcohol Use Disorders, run by Brigham and Women's Hospital at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Alcohol Use Disorders
- What is being tested?
- Brief Counseling Intervention (BCI), Naltrexone and BCI + Naltrexone
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteRussia
- Study dates
- Jan 2007to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Alcohol Interventions Among TB Patients in Tomsk Oblast, Russia
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:
Read more
- 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.
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:
- 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.
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.
Read the detailed description
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.
- Conditions
- Tuberculosis, Alcohol Use Disorders
- Being tested
- Brief Counseling Intervention (BCI), Naltrexone, BCI + Naltrexone, Treatment as Usual
- Keywords
- Tomsk, TB-Alcohol, Alcohol and co-occurring disease, Brief counseling intervention, Naltrexone
- Medical subject headings
- Tuberculosis, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Counseling Intervention (BCI)Behavioural
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.
NaltrexoneDrug
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 + NaltrexoneOther
Combination of the two previous interventions
Treatment as UsualBehavioural
Services provided by psychologists and narcologists (additions specialists) employed by the Tomsk Oblast TB Services.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Behavioral Counseling Intervention (BCI) plus treatment as usual (TAU) (i.e. standard referral to and management by an addictions specialist) Receives: Behavioral: Brief Counseling Intervention (BCI) |
| 2 | Experimental | Naltrexone/ Brief Behavioral Compliance Enhancement Treatment (BBCET) plus TAU Receives: Drug: Naltrexone |
| 3 | Experimental | BCI + Naltrexone/BBCET plus TAU Receives: Other: BCI + Naltrexone |
| 4 | Active comparator | Treatment as Usual (TAU) Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol: change in mean number of heavy drinking days in last month of study period compared with baseline
Measured: 6 months
TB: successful treatment vs. non-successful treatment as defined by the WHO
Measured: 6 months
Secondary outcomes (5)
Time to death
Measured: 6 months
Nonadherence to TB therapy, defined as having taken less than 80% of indicated doses
Measured: 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
Measured: 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
Measured: 6 months
Change in mean Addiction Severity Index (ASI) alcohol scores at the end of the study period, compared with baseline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2008 (estimated)
- Study startJan 2007
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mclean Hospital, Harvard School of Public Health (HSPH)
- Responsible party
- Principal investigator, Sonya Sunhi Shin, Brigham and Women's Hospital
- Investigators
- Sonya S Shin, MD, MPH, Principal investigator, Division of Global Health Equity, Brigham and Women's Hospital; Harvard Medical SchoolViktoriya Livchits, MD, MSc, Study director, Division of Global Health Equity, Brigham and Women's Hospital; Partners In Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675961
- Sponsor's protocol ID
- 2005P-002539
- Other IDs
- NIH 1 RO1 AA016318-01
- Acronym
- IMPACT
- Status last verified
- Oct 2017
- First submitted
- 8 May 2008
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37158538Miller 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.
PubMed 26871943Connery 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.
PubMed 23750742
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Alcohol Interventions Among TB Patients in Tomsk Oblast, Russia
- ClinicalTrials.gov ID
- NCT00675961
- Acronym / sponsor ID
- IMPACT / 2005P-002539
- Conditions
- Tuberculosis, Alcohol Use Disorders
- Keywords
- Tomsk, TB-Alcohol, Alcohol and co-occurring disease, Brief counseling intervention, Naltrexone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Mclean Hospital, Harvard School of Public Health (HSPH)
- Study start
- Jan 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 12 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Brief Counseling Intervention (BCI)Behavioral Counseling Intervention (BCI) plus treatment as usual (TAU) (i.e. standard referral to and management by an addictions specialist) |
| 2 | Experimental | Drug: NaltrexoneNaltrexone/ Brief Behavioral Compliance Enhancement Treatment (BBCET) plus TAU |
| 3 | Experimental | Other: BCI + NaltrexoneBCI + Naltrexone/BBCET plus TAU |
| 4 | Active comparator | Behavioral: Treatment as UsualTreatment as Usual (TAU) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | 1 |
| NaltrexoneOpioid antagonist, which decreases the pleasurable response to and craving for alcohol consumption. Oral; single daily dose of 50 mg per day for 6 months. | Drug | 2 |
| BCI + NaltrexoneCombination of the two previous interventions | Other | 3 |
| Treatment as UsualServices provided by psychologists and narcologists (additions specialists) employed by the Tomsk Oblast TB Services. | Behavioural | 4 |
Primary outcome
Alcohol: change in mean number of heavy drinking days in last month of study period compared with baseline
Time frame: 6 months
TB: successful treatment vs. non-successful treatment as defined by the WHO
Time frame: 6 months
5 secondary outcomes
Time to death
Time frame: 6 months
Nonadherence to TB therapy, defined as having taken less than 80% of indicated doses
Time frame: 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
Time frame: 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
Time frame: 6 months
Change in mean Addiction Severity Index (ASI) alcohol scores at the end of the study period, compared with baseline
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Derived from this study: PubMed 37158538Greene 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.
- Derived from this study: PubMed 26871943Miller 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.
- Derived from this study: PubMed 23750742Connery 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonya S Shin, MD, MPH principal investigator
Division of Global Health Equity, Brigham and Women's Hospital; Harvard Medical School
Viktoriya Livchits, MD, MSc study director
Division of Global Health Equity, Brigham and Women's Hospital; Partners In Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Counseling Intervention (BCI), Naltrexone and BCI + Naltrexone in people with Tuberculosis and Alcohol Use Disorders, run by Brigham and Women's Hospital at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol: change in mean number of heavy drinking days in last month of study period compared with baseline (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00675961, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2017.