Clinical trial NCT03345394: 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
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Contingency Management
Addiction, Cocaine
Keywords: crack cocaine
contingency management
ambulatory treatment
Brazil
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Washington State University
First posted: 2017-11-17
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* DSM-V diagnose for crack cocaine use disorder

Exclusion Criteria:

* being under 18 years old

Primary outcomes:
measure: Pattern of Crack Cocaine Use
timeFrame: 12 weeks
measure: Promotion of Continuous Crack Cocaine Abstinence
timeFrame: 12 weeks
Secondary outcomes:
measure: Treatment Retention
timeFrame: 12 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Unidade Recomeço Helvétia
state: Sao Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Andre M de Queiroz Constantino Miguel, PhD
role: PRINCIPAL_INVESTIGATOR
References: