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

Substance Use Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03345394
• Other study ID #: FAPESP 2017/05371-8
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: December 1, 2020

Study information

• Verified date: March 2021
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• DSM-V diagnose for crack cocaine use disorder

Exclusion Criteria:

• being under 18 years old

Related Conditions & MeSH terms

• Addiction, Cocaine
• Behavior, Addictive
• Cocaine-Related Disorders
• Contingency Management
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Contingency Management
Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples
• Standard treatment
Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program

Locations

Country	Name	City	State
Brazil	Unidade Recomeço Helvétia	São Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Washington State University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pattern of Crack Cocaine Use	Percentage of negative crack cocaine urine samples submitted during the 12 weeks of treatment	12 weeks
Primary	Promotion of Continuous Crack Cocaine Abstinence	Longest duration of continuous abstinence achieved (in weeks)	12 weeks
Secondary	Treatment Retention	time elapsed between treatment entry and last time present in treatment (in weeks)	12 weeks