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Clinical Trials/NCT03345394
NCT03345394CompletedNot Applicable

Effectiveness of Contingency Management in the Treatment of Crack Addiction for Individuals Living in the "Crackland" Region. A Single-blind Randomized Controlled Trial

Federal University of São Paulo2 sites in 1 country98 target enrollmentStarted: December 1, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
98
Locations
2
Primary Endpoint
Pattern of Crack Cocaine Use

Study Overview

Brief Summary

Crack addiction has become a severe public health problem in Brazil. Crack users present elevated prevalence rates of psychiatric comorbidities, sexual transmitted infections and unemployment with high probability of living or have lived in the streets, history of incarceration and engagement in illegal activities. For the last 20 years a treatment called Contingency Management (CM) have achieved the best results regarding reduction of substance use, promotion of abstinence, treatment attendance and retention in treatment. The first CM study conducted in Brazil advocates for the efficacy of CM on all of these outcomes, suggesting that CM can be effective in a Brazilian population of crack users.

Detailed Description

The objective of this study is to evaluate the effectiveness of Contingency Management (CM) for crack users living in the "Crackland" region. To achieve this goal, regular treatment staff from Unidade Recomeço Helvétia treatment service will be capacitated in CM to latter-on apply the CM intervention in their respective services. The design will be a single-blind randomized clinical trial composed of a sample of 100 subjects with current diagnose for crack/cocaine dependence. Participants allocated to the control condition will receive 12 weeks of the usual care treatment provided by these two treatment facilities. Participants allocated to the experimental condition will receive the exact same treatment as control participants associated with CM. CM procedure will occur 2 timer per week (every Monday and Thursday or Tuesday and Friday). Primary outcomes are: (1)retention in treatment; (2) reduction of crack use; (3) promotion of continuous crack cocaine abstinence. Secondary findings are reduction on psychiatric symptomatology. The investigator hypothesis is that participants in the CM condition will have a better treatment response in all studied outcomes.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Masking Description

researchers had no contact with participants during the 12 week trial

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • DSM-V diagnose for crack cocaine use disorder

Exclusion Criteria

  • being under 18 years old

Outcomes

Primary Outcomes

Pattern of Crack Cocaine Use

Time Frame: 12 weeks

Percentage of negative crack cocaine urine samples submitted during the 12 weeks of treatment

Promotion of Continuous Crack Cocaine Abstinence

Time Frame: 12 weeks

Longest duration of continuous abstinence achieved (in weeks)

Secondary Outcomes

  • Treatment Retention(12 weeks)

Investigators

Sponsor
Federal University of São Paulo
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

André de Queiroz Constantino Miguel

Principal Investigator

Federal University of São Paulo

Study Sites (2)

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