Contingency Management Treatment for Crack Addiction - Study With Brazilian Population

This study is ongoing, but not recruiting participants.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01815645
First received: March 18, 2013
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Cocaine Related Disorders
Behavioral: Standard treatment plus Contingence Management
Behavioral: standard treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 Federal University of São Paulo:

Primary Outcome Measures:
  • Treatment retention [ Time Frame: measured during the 12 weeks of treatment ] [ Designated as safety issue: No ]

    Data on Treatment retention will be collected considering participants that complete 12 weeks of treatment and participants that abandons treatment during the 12 weeks of study.

    Specific time of drop-out will also be considered.


  • reduction of crack use [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]
  • promotion of continued abstinence [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]
    continued abstinence will be measured by considering all participants that achieved at least 8 weeks of continued abstinence.


Secondary Outcome Measures:
  • Beck depression inventory [ Time Frame: 12 weeks of treatment, 3 and 6-month follow up ] [ Designated as safety issue: No ]
  • beck anxiety inventory [ Time Frame: 12 weeks of treatment and 3-6 month follow up ] [ Designated as safety issue: No ]
  • ASSIST scores on crack and other substances [ Time Frame: 12 week of treatment 3 and 6 month follow up ] [ Designated as safety issue: No ]
  • Cocaine craving Questionnaire Bief scores [ Time Frame: 12 weeks of treatment and 3-6 month follow-up ] [ Designated as safety issue: No ]
  • Minnesota Cocaine Craving Scale scores [ Time Frame: 12 weeks of treatment, 3-6month follow ups ] [ Designated as safety issue: No ]
  • reduction of crack use [ Time Frame: at 3 and 6-month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Standard treatment 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: Standard treatment plus Contingency Management Behavioral: 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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)
Study First Received: March 18, 2013
Last Updated: May 16, 2014
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: Fundação de Amparo a Pesquisa do Estado de Sao Paulo

Keywords provided by Federal University of São Paulo:
Cocaine related disorders
Contingency Management
psychosocial treatment

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

ClinicalTrials.gov processed this record on October 23, 2014