Status:
COMPLETED
Effectiveness of Alcohol Interventions Among Tuberculosis (TB) Patients in Tomsk Oblast, Russia
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Mclean Hospital
Harvard School of Public Health (HSPH)
Conditions:
Tuberculosis
Alcohol Use Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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-occu...
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 ex...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00675961
Start Date
January 1 2007
End Date
June 1 2011
Last Update
October 25 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tomsk Oblast TB Services
Tomsk, Tomsk Oblast, Russia