Contingency Management Treatment for Crack Addiction - Study With Brazilian Population

July 26, 2017 updated by: André de Queiroz Constantino Miguel, Federal University of São Paulo

Evaluating the Efficacy of Including Contingency Management to Standard Ambulatory Treatment for Crack Addiction - A Randomized Controlled Trial

Crack addiction has become a severe health problem in Brazil. Today, crack addiction is the primary cause for inpatient treatment for all illicit substances. When compared to cocaine, crack users develop much faster diagnoses for crack dependence, 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 is 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) can be affective in the treatment of crack addiction in Brazil. 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+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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a Randomized Clinical Trial deigned to investigate the effects of including Contingency Management to a standard public ambulatory treatment in Brazil on treatment attendance, retention in treatment, reduction of crack cocaine use and promotion of crack cocaine abstinence for crack dependent individuals seeking treatment for there addiction. In total 65 subjects will be randomized to receive Standard Treatment Alone or Standard Treatment plus Contingency Management. Both interventions will last for 12 weeks.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil
        • Ambulatorio Medico de Especialidades (AME) da Vila Maria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Current diagnose of crack addiction (DSM IV)
  • having used crack in the last month

Exclusion Criteria:

  • Current psychotic disorder
  • Diagnose of schizophrenia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Standard treatment Alone
Participants in the Standard Treatment Alone group will receive 12 weeks of the exact treatment provided by the Ambulatory service where the study is being conducted
Behavioral: standard treatment
12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
EXPERIMENTAL: ST+CM
Participants in the Standard treatment plus Contingency Management (ST+CM) group will receive 12 weeks of the exact treatment provided by the Ambulatory service where the study is being conducted plus CM.
Behavioral: ST+CM
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Longest Duaration of Achieved Abstinance
Time Frame: 12 weeks of treatment
Number of Participants with 4, 8 and 12 Weeks Continued Abstinence
12 weeks of treatment
Percentage Samples Submitted Negative for Crack Cocaine Use
Time Frame: 12 weeks
Proportion of samples testing negative for Crack Cocaine use
12 weeks
Number of Participants Completing 4, 8 and 12 Weeks of Treatment
Time Frame: Number of participant retained in treatment at weeks 4, 8 and 12.
Retention in treatment was quantified as the period elapsed between treatment intake and dropout (last appearance at the treatment facility) or the end of treatment. We present data on the number of participants retained in treatment in weeks 4, 8 and 12.
Number of participant retained in treatment at weeks 4, 8 and 12.
Treatment Attendance
Time Frame: 12 weeks
Treatment attendance was expressed as the total number of sessions attended during the 12 weeks of treatment.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Samples Submitted Negative for Alcohol Use
Time Frame: 12 weeks
Proportion of samples testing negative for alcohol use
12 weeks
Percentage Samples Submitted Negative for Marihuana Use
Time Frame: 12 weeks
The proportion of samples testing negative for marijuana was determined by dividing the number of negative samples by the total number of expected samples (36 samples)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Ronaldo R Laranjeira, PhD, EPM/UNIFESP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

March 18, 2013

First Submitted That Met QC Criteria

March 20, 2013

First Posted (ESTIMATE)

March 21, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 27, 2017

Last Update Submitted That Met QC Criteria

July 26, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/01469-7 (FAPESP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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