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

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

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.

Study Overview

• Status: Completed
• Conditions: Contingency Management; Substance Use Disorders; Addiction, Cocaine
• Intervention / Treatment: Behavioral: Standard treatment; Behavioral: Contingency Management

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 Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • São Paulo, Sao Paulo, Brazil, 01215-010
      • Unidade Recomeço Helvétia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• DSM-V diagnose for crack cocaine use disorder

Exclusion Criteria:

• being under 18 years old

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Collaborators: Washington State University
• Investigators: Principal Investigator: Andre M de Queiroz Constantino Miguel, PhD, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Brazil; crack cocaine; contingency management; ambulatory treatment
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Compulsive Behavior; Impulsive Behavior; Substance-Related Disorders; Behavior, Addictive; Cocaine-Related Disorders
• Other Study ID Numbers: FAPESP 2017/05371-8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No