NCT01558726

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

March 20, 2012

Status Verified

March 1, 2012

Enrollment Period

10 months

First QC Date

March 17, 2012

Last Update Submit

March 17, 2012

Conditions

Keywords

Case ManagementCrack abuse/dependentsEvaluationInpatientASITreatment retentionAbstinence

Outcome Measures

Primary Outcomes (1)

  • Treatment retention

    3 months

Secondary Outcomes (2)

  • Crack abstinence

    3 months

  • ASI subareas scores

    3 months

Study Arms (2)

Case management

EXPERIMENTAL
Behavioral: Case Management (Strength-Based)

Usual treatment

ACTIVE COMPARATOR

Usual treatment of the CAPSad

Behavioral: Usual Treatment

Interventions

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.

Case management
Usual TreatmentBEHAVIORAL

The usual treatment used for regular patients of CAPSad

Usual treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of crack abuse or dependence
  • \> 18 years old
  • Initiating treatment (maximum of 1 month)

You may not qualify if:

  • Homeless without permanent contact
  • Psychotic symptoms during the intake interview

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Drug and Alcohol Research (CPAD) of Federal University of Rio Grande do Sul (UFRGS)

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

MeSH Terms

Interventions

Case Management

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Flavio Pechansky, PhD

    Center for Drug and Alcohol Research (CPAD) of Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Flavio Pechansky, PhD

CONTACT

Felix HP Kessler, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Center for Drug and Alcohol Research (CPAD-UFRGS)

Study Record Dates

First Submitted

March 17, 2012

First Posted

March 20, 2012

Study Start

October 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

March 20, 2012

Record last verified: 2012-03

Locations