Contingency Management Treatment for Crack Addiction - Study With Brazilian Population
Primary Purpose
Cocaine Related Disorders
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
ST+CM
standard treatment
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine Related Disorders focused on measuring Cocaine related disorders, Contingency Management, psychosocial treatment
Eligibility 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
Sites / Locations
- Ambulatorio Medico de Especialidades (AME) da Vila Maria
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard treatment Alone
ST+CM
Arm Description
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
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.
Outcomes
Primary Outcome Measures
Longest Duaration of Achieved Abstinance
Number of Participants with 4, 8 and 12 Weeks Continued Abstinence
Percentage Samples Submitted Negative for Crack Cocaine Use
Proportion of samples testing negative for Crack Cocaine use
Number of Participants Completing 4, 8 and 12 Weeks of Treatment
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
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
Proportion of samples testing negative for alcohol use
Percentage Samples Submitted Negative for Marihuana Use
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)
Full Information
NCT ID
NCT01815645
First Posted
March 18, 2013
Last Updated
July 26, 2017
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01815645
Brief Title
Contingency Management Treatment for Crack Addiction - Study With Brazilian Population
Official Title
Evaluating the Efficacy of Including Contingency Management to Standard Ambulatory Treatment for Crack Addiction - A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Related Disorders
Keywords
Cocaine related disorders, Contingency Management, psychosocial treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Both participants and researchers know the treatment alocations
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard treatment Alone
Arm Type
Active Comparator
Arm Description
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
Arm Title
ST+CM
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ST+CM
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
standard treatment
Intervention Description
12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
Primary Outcome Measure Information:
Title
Longest Duaration of Achieved Abstinance
Description
Number of Participants with 4, 8 and 12 Weeks Continued Abstinence
Time Frame
12 weeks of treatment
Title
Percentage Samples Submitted Negative for Crack Cocaine Use
Description
Proportion of samples testing negative for Crack Cocaine use
Time Frame
12 weeks
Title
Number of Participants Completing 4, 8 and 12 Weeks of Treatment
Description
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.
Time Frame
Number of participant retained in treatment at weeks 4, 8 and 12.
Title
Treatment Attendance
Description
Treatment attendance was expressed as the total number of sessions attended during the 12 weeks of treatment.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Percentage Samples Submitted Negative for Alcohol Use
Description
Proportion of samples testing negative for alcohol use
Time Frame
12 weeks
Title
Percentage Samples Submitted Negative for Marihuana Use
Description
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)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronaldo R Laranjeira, PhD
Organizational Affiliation
EPM/UNIFESP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ambulatorio Medico de Especialidades (AME) da Vila Maria
City
Sao Paulo
State/Province
SP
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27442691
Citation
Miguel AQ, Madruga CS, Cogo-Moreira H, Yamauchi R, Simoes V, da Silva CJ, McPherson S, Roll JM, Laranjeira RR. Contingency management is effective in promoting abstinence and retention in treatment among crack cocaine users in Brazil: A randomized controlled trial. Psychol Addict Behav. 2016 Aug;30(5):536-543. doi: 10.1037/adb0000192. Epub 2016 Jul 21.
Results Reference
background
PubMed Identifier
32026092
Citation
de Queiroz Constantino Miguel A, Sandi Madruga C, Simoes V, Yamauchi R, da Silva CJ, McDonell M, McPherson S, Roll J, Laranjeira RR, de Jesus Mari J. Contingency management is effective in promoting abstinence and retention in treatment among crack cocaine users with a previous history of poor treatment response: a crossover trial. Psicol Reflex Crit. 2019 Jul 15;32(1):14. doi: 10.1186/s41155-019-0127-2.
Results Reference
derived
PubMed Identifier
29251975
Citation
Miguel AQC, Madruga CS, Cogo-Moreira H, Yamauchi R, Simoes V, Ribeiro A, da Silva CJ, Fruci A, McDonell M, McPherson S, Roll JM, Laranjeira RR. Contingency management targeting abstinence is effective in reducing depressive and anxiety symptoms among crack cocaine-dependent individuals. Exp Clin Psychopharmacol. 2017 Dec;25(6):466-472. doi: 10.1037/pha0000147.
Results Reference
derived
Learn more about this trial
Contingency Management Treatment for Crack Addiction - Study With Brazilian Population
We'll reach out to this number within 24 hrs