Effectiveness of Contingency Management in the Treatment of Crack Addiction in Brazil

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Substance Use Disorders, Contingency Management, Addiction, Cocaine

Intervention / Treatment
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* Behavioral: Contingency Management
* Behavioral: Standard treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DSM-V diagnose for crack cocaine use disorder Exclusion Criteria: being under 18 years old

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-blind randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Treatment<br>12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program | Behavioral: Standard treatment<br>* Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program<br>|
| Experimental: Contingency Management<br>12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management | Behavioral: Contingency Management<br>* Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pattern of Crack Cocaine Use | Percentage of negative crack cocaine urine samples submitted during the 12 weeks of treatment | 12 weeks | 
| Promotion of Continuous Crack Cocaine Abstinence | Longest duration of continuous abstinence achieved (in weeks) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Retention | time elapsed between treatment entry and last time present in treatment (in weeks) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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crack cocaine, contingency management, ambulatory treatment, Brazil