Contingency Management Treatment for Crack Addiction - Study With Brazilian Population
|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.|
|ClinicalTrials.gov Identifier: NCT01815645|
Recruitment Status : Completed
First Posted : March 21, 2013
Results First Posted : June 19, 2017
Last Update Posted : July 27, 2017
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 or disease||Intervention/treatment||Phase|
|Cocaine Related Disorders||Behavioral: ST+CM Behavioral: standard treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Both participants and researchers know the treatment alocations|
|Official Title:||Evaluating the Efficacy of Including Contingency Management to Standard Ambulatory Treatment for Crack Addiction - A Randomized Controlled Trial|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
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)
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.
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
- 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.
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815645
|Ambulatorio Medico de Especialidades (AME) da Vila Maria|
|Sao Paulo, SP, Brazil|
|Principal Investigator:||Ronaldo R Laranjeira, PhD||EPM/UNIFESP|