Case Management for Crack Users Who Seek Treatment in CAP... | NCT01558726

Studies
Case Management for Crack Users Who Seek Treatment in CAPSad in Brazil

NCT01558726

Sponsor

Federal University of Rio Grande do Sul

Status

Unknown status

Last Update Posted

Mar 20, 2012Estimated

Enrollment

600Estimated

Phase

Not Applicable

Conditions

Crack Abuse or Dependence

Interventions

Case Management (Strength-Based)
Usual Treatment

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Aug 2012Estimated

Completion Date

Aug 2012Estimated

First Submitted Date

Mar 17, 2012

First Submission Date that Met QC Criteria

Mar 17, 2012

First Posted Date

Mar 20, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2012

Last Update Posted Date

Mar 20, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Professor Flavio Pechansky, Director of Center for Drug and Alcohol Research (CPAD-UFRGS), Federal University of Rio Grande do SulPrincipal Investigator

Lead Sponsor

Federal University of Rio Grande do SulOTHER

Collaborators

Name	Class
Hospital de Clinicas de Porto Alegre	OTHER
Brazilian Secretariat for Drug Policies (SENAD)	UNKNOWN
Federal University of Bahia	OTHER
Federal University of Espirito Santo

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Case management	Experimental		Behavioral: Case Management (Strength-Based)
Usual treatment	Active Comparator	Usual treatment of the CAPSad	Behavioral: Usual Treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Case Management (Strength-Based)	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment retention		3 months

Secondary Outcomes

Measure	Description	Time Frame
Crack abstinence		3 months
ASI subareas scores	ASI (Addiction Severity Index)	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Flavio Pechansky, PhD	Contact	55-51-3359-7480		fpechans@uol.com.br
Felix HP Kessler, PhD	Contact

Overall Officials

Name	Affiliation	Role
Flavio Pechansky, PhD	Center for Drug and Alcohol Research (CPAD) of Federal University of Rio Grande do Sul	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Drug and Alcohol Research (CPAD) of Federal University of Rio Grande do Sul (UFRGS)	Recruiting	Porto Alegre	Rio Grande do Sul	90035-903	Brazil

Intervention Browse Module

MeSH Terms

ID	Term
D019090	Case Management

Ancestor Terms

ID	Term
D010347	Patient Care Planning
D003191	Comprehensive Health Care
D010346	Patient Care Management
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided