- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01558726
Case Management for Crack Users Who Seek Treatment in CAPSad in Brazil
March 17, 2012 updated by: Professor Flavio Pechansky, Federal University of Rio Grande do Sul
Effectiveness of Case Management for Crack Users Who Seek Treatment in CAPSad in Six Brazilian Capitals
The purpose of this study is to evaluate the effectiveness of a Case Management (CM) intervention in crack users applied in Psychosocial Care Centers - Alcohol and Drugs (CAPSad) by trained social workers, in comparison to CAPSad conventional treatment on 30 and 90 days, considering the following outcomes: treatment retention, abstinence and changes in severity scores of the sixth version of Addiction Severity Index (ASI6) scale.
The study hypothesis are: 1) The CM is going to improve the retention of crack users (cases) during the 3-month follow-up compared with usual care (controls); 2)Individuals who received the intervention with GC are going to present a higher rate of abstinence; 3)The summary scores of the ASI6 will be significantly lower in cases than in controls, at the end of 3 months follow-up.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Flavio Pechansky, PhD
- Phone Number: 55-51-3359-7480
- Email: fpechans@uol.com.br
Study Contact Backup
- Name: Felix HP Kessler, PhD
Study Locations
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
- Recruiting
- Center for Drug and Alcohol Research (CPAD) of Federal University of Rio Grande do Sul (UFRGS)
-
Contact:
- Flavio Pechansky, PhD
- Phone Number: 55-51-3359-7480
- Email: fpechans@uol.com.br
-
Contact:
- Felix HP Kessler, PhD
- Phone Number: 55-51-3359-7480
- Email: kessler.ez@terra.com.br
-
Principal Investigator:
- Flavio Pechansky, PhD
-
Sub-Investigator:
- Felix HP Kessler, PhD
-
Sub-Investigator:
- Sibele Faller, Ms
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of crack abuse or dependence
- > 18 years old
- Initiating treatment (maximum of 1 month)
Exclusion Criteria:
- Homeless without permanent contact
- Psychotic symptoms during the intake interview
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Case management
|
To improve the cases sharing between CAPSad and other health institutions and individuals and increase the strengths of the patient to cope with problems related to the crack use.
|
Active Comparator: Usual treatment
Usual treatment of the CAPSad
|
The usual treatment used for regular patients of CAPSad
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Treatment retention
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Crack abstinence
Time Frame: 3 months
|
3 months
|
|
ASI subareas scores
Time Frame: 3 months
|
ASI (Addiction Severity Index)
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Flavio Pechansky, PhD, Center for Drug and Alcohol Research (CPAD) of Federal University of Rio Grande do Sul
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Anticipated)
August 1, 2012
Study Completion (Anticipated)
August 1, 2012
Study Registration Dates
First Submitted
March 17, 2012
First Submitted That Met QC Criteria
March 17, 2012
First Posted (Estimate)
March 20, 2012
Study Record Updates
Last Update Posted (Estimate)
March 20, 2012
Last Update Submitted That Met QC Criteria
March 17, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 10-0176
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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