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

NCT ID: NCT03345394

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2020-12-01

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.

Conditions

Substance Use Disorders; Contingency Management; Addiction, Cocaine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard Treatment

12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program

Group Type: ACTIVE_COMPARATOR

Standard treatment

Intervention Type: BEHAVIORAL

Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program

Contingency Management

12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management

Group Type: EXPERIMENTAL

Contingency Management

Intervention Type: BEHAVIORAL

Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples

Interventions

Contingency Management

Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples

Intervention Type: BEHAVIORAL

Standard treatment

Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• DSM-V diagnose for crack cocaine use disorder

Exclusion Criteria

• being under 18 years old

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington State University

OTHER

Sponsor Role: collaborator

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

André de Queiroz Constantino Miguel

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andre M de Queiroz Constantino Miguel, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

Unidade Recomeço Helvétia

São Paulo, São Paulo, Brazil

Countries

Brazil

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

FAPESP 2017/05371-8

Identifier Type: -

Identifier Source: org_study_id