Overview

This trial is active, not recruiting.

Condition cocaine related disorders
Treatments standard treatment plus contingence management, standard treatment
Sponsor Federal University of São Paulo
Collaborator Fundação de Amparo à Pesquisa do Estado de São Paulo
Start date May 2012
End date June 2015
Trial size 60 participants
Trial identifier NCT01815645, 2011/01469-7 (FAPESP)

Summary

Crack addiction has became a severe health problem in Brazil. Today, crack addiction is the primary cause for inpatient treatment (voluntary or not) for all illicit substances (losing only for alcohol addiction). A survey study conducted with children and adolescents currently living in the streets of 5 major cities of Brazil, point alarming results in which 15% to 26% of all these children have smoked crack at least once in the last month.

When compared to cocaine, crack users develop much faster diagnoses for crack dependence (mean of 5 month after first use), shows a more compulsive pattern of use, has higher probability of living or have lived in the streets, and of engaging in illegal activities. Consequently to this, mortality of crack addicts are 7 times higher than for the rest of the population.

Despite all efforts being made for the development of effective pharmacological treatments for stimulant addiction (crack included), up to today, there is no robust evidence of efficacy of any pharmacological treatment. For that reason, the use of evidence based psychosocial interventions is so important for treating this population.

Although today open treatment facilities in Brazil are more and more starting to use evidence based interventions such as motivational interviewing, cognitive behavior therapy, relapse prevention and coping skills, such treatments present very modest results when treating crack addiction. The biggest difficulties encountered when treating this population are maintaining patients in treatment, reducing crack use and achieving continued abstinence.

A psychosocial treatment based in behavioral principals' named Contingency Management (CM) is widely applied in the USA. Recent meta-analyses and review studies present robust evidence that, when applied alone or in adjunction with other psychosocial and pharmacological treatment, CM is the most effective treatment for what regards, treatment retention, reducing drug use and promoting continued abstinence.

The purpose of this study is to evaluate if Contingence Management (CM) treatment can be affective on the treatment of crack addiction for Brazilian population seeking outpatient treatment.

To accomplish this, 60 individuals (male and female from 18 to 65 years of age) seeking open treatment for crack addiction will be randomized to 2 treatment conditions (Standard treatment (ST) or ST plus CM). Both treatments will last 12 weeks with 3 and 6-month follow-up. In both groups patients will be encourage to leave urine samples 3 times week.

Hypotheses: Patients receiving ST+CM will stay longer in treatment, have more negative tests for cocaine/crack, and achieve longer periods of cocaine/crack abstinence when compared to patients receiving ST alone.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
standard treatment
12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
(Experimental)
standard treatment plus contingence management
12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management

Primary Outcomes

Measure
Treatment retention
time frame: measured during the 12 weeks of treatment
reduction of crack use
time frame: 12 weeks of treatment
promotion of continued abstinence
time frame: 12 weeks of treatment

Secondary Outcomes

Measure
Beck depression inventory
time frame: 12 weeks of treatment, 3 and 6-month follow up
beck anxiety inventory
time frame: 12 weeks of treatment and 3-6 month follow up
ASSIST scores on crack and other substances
time frame: 12 week of treatment 3 and 6 month follow up
Cocaine craving Questionnaire Bief scores
time frame: 12 weeks of treatment and 3-6 month follow-up
Minnesota Cocaine Craving Scale scores
time frame: 12 weeks of treatment, 3-6month follow ups
reduction of crack use
time frame: at 3 and 6-month follow-up

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Current diagnose of crack addiction (DSM IV) - having used crack in the last month Exclusion Criteria: - Current psychotic disorder - Diagnose of schizophrenia

Additional Information

Official title Evaluating the Efficacy of Including Contingency Management to Standard Ambulatory Treatment for Crack Addiction - A Randomized Controlled Trial
Principal investigator Ronaldo R Laranjeira, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Federal University of São Paulo.