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Contingency Management Treatment for Crack Addiction - Study With Brazilian Population

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01815645
First Posted: March 21, 2013
Last Update Posted: July 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
André de Queiroz Constantino Miguel, Federal University of São Paulo
  Purpose

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.


Condition Intervention
Cocaine Related Disorders Behavioral: ST+CM Behavioral: standard treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
Both participants and researchers know the treatment alocations
Primary Purpose: Treatment
Official Title: Evaluating the Efficacy of Including Contingency Management to Standard Ambulatory Treatment for Crack Addiction - A Randomized Controlled Trial

Further study details as provided by André de Queiroz Constantino Miguel, Federal University of São Paulo:

Primary Outcome Measures:
  • Longest Duaration of Achieved Abstinance [ Time Frame: 12 weeks of treatment ]
    Number of Participants with 4, 8 and 12 Weeks Continued Abstinence

  • Percentage Samples Submitted Negative for Crack Cocaine Use [ Time Frame: 12 weeks ]
    Proportion of samples testing negative for Crack Cocaine use

  • 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.

  • Treatment Attendance [ Time Frame: 12 weeks ]
    Treatment attendance was expressed as the total number of sessions attended during the 12 weeks of treatment.


Secondary Outcome Measures:
  • Percentage Samples Submitted Negative for Alcohol Use [ Time Frame: 12 weeks ]
    Proportion of samples testing negative for alcohol use

  • 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)


Enrollment: 65
Study Start Date: May 2012
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Current psychotic disorder
  • Diagnose of schizophrenia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815645


Locations
Brazil
Ambulatorio Medico de Especialidades (AME) da Vila Maria
Sao Paulo, SP, Brazil
Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Ronaldo R Laranjeira, PhD EPM/UNIFESP
  More Information

Publications:
Responsible Party: André de Queiroz Constantino Miguel, Ph.D Studant, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01815645     History of Changes
Other Study ID Numbers: 2011/01469-7 (FAPESP)
First Submitted: March 18, 2013
First Posted: March 21, 2013
Results First Submitted: August 10, 2015
Results First Posted: June 19, 2017
Last Update Posted: July 27, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by André de Queiroz Constantino Miguel, Federal University of São Paulo:
Cocaine related disorders
Contingency Management
psychosocial treatment

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders