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

Crack Abuse or Dependence Clinical Trial

Official title:

Effectiveness of Case Management for Crack Users Who Seek Treatment in CAPSad in Six Brazilian Capitals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01558726
• Other study ID #: 10-0176
• Status: Recruiting
• Phase: N/A
• First received: March 17, 2012
• Last updated: March 17, 2012
• Start date: October 2011
• Est. completion date: August 2012

Study information

• Verified date: March 2012
• Source: Federal University of Rio Grande do Sul
• Contact: Flavio Pechansky, PhD
• Phone: 55-51-3359-7480
• Email: fpechans[@]uol.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crack Abuse or Dependence

Intervention

Behavioral:
• Case Management (Strength-Based)
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.
• Usual Treatment
The usual treatment used for regular patients of CAPSad

Locations

Country	Name	City	State
Brazil	Center for Drug and Alcohol Research (CPAD) of Federal University of Rio Grande do Sul (UFRGS)	Porto Alegre	Rio Grande do Sul

Sponsors (8)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul	Brazilian Secretariat for Drug Policies (SENAD), Faculdade de Medicina do ABC, Federal University of Bahia, Federal University of Espirito Santo, Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio de Janeiro, University of Brasilia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment retention		3 months	No
Secondary	Crack abstinence		3 months	No
Secondary	ASI subareas scores	ASI (Addiction Severity Index)	3 months	No