Back to resultsEffectiveness of Contingency Management in the Treatment of Crack Addiction in Brazil
Primary Purpose
Substance Use Disorders, Contingency Management, Addiction, Cocaine
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Contingency Management
Standard treatment
Sponsored by
About this trial
This is an interventional treatment trial for Substance Use Disorders focused on measuring crack cocaine, contingency management, ambulatory treatment, Brazil
Eligibility Criteria
Inclusion Criteria:
- DSM-V diagnose for crack cocaine use disorder
Exclusion Criteria:
- being under 18 years old
Sites / Locations
- Unidade Recomeço Helvétia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Treatment
Contingency Management
Arm Description
12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program
12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management
Outcomes
Primary Outcome Measures
Pattern of Crack Cocaine Use
Percentage of negative crack cocaine urine samples submitted during the 12 weeks of treatment
Promotion of Continuous Crack Cocaine Abstinence
Longest duration of continuous abstinence achieved (in weeks)
Secondary Outcome Measures
Treatment Retention
time elapsed between treatment entry and last time present in treatment (in weeks)
Full Information
NCT ID
NCT03345394
First Posted
November 14, 2017
Last Updated
March 16, 2021
Sponsor
Federal University of São Paulo
Collaborators
Washington State University
1. Study Identification
Unique Protocol Identification Number
NCT03345394
Brief Title
Effectiveness of Contingency Management in the Treatment of Crack Addiction in Brazil
Official Title
Effectiveness of Contingency Management in the Treatment of Crack Addiction for Individuals Living in the "Crackland" Region. A Single-blind Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Washington State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, Contingency Management, Addiction, Cocaine
Keywords
crack cocaine, contingency management, ambulatory treatment, Brazil
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-blind randomized controlled trial
Masking
Investigator
Masking Description
researchers had no contact with participants during the 12 week trial
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Treatment
Arm Type
Active Comparator
Arm Description
12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program
Arm Title
Contingency Management
Arm Type
Experimental
Arm Description
12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples
Intervention Type
Behavioral
Intervention Name(s)
Standard treatment
Intervention Description
Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program
Primary Outcome Measure Information:
Title
Pattern of Crack Cocaine Use
Description
Percentage of negative crack cocaine urine samples submitted during the 12 weeks of treatment
Time Frame
12 weeks
Title
Promotion of Continuous Crack Cocaine Abstinence
Description
Longest duration of continuous abstinence achieved (in weeks)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Treatment Retention
Description
time elapsed between treatment entry and last time present in treatment (in weeks)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
DSM-V diagnose for crack cocaine use disorder
Exclusion Criteria:
being under 18 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre M de Queiroz Constantino Miguel, PhD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unidade Recomeço Helvétia
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01215-010
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Contingency Management in the Treatment of Crack Addiction in Brazil
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