Ignite Creation Date:
2024-05-06 @ 1:27 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01815645
Status:
COMPLETED
Last Update Posted:
2017-07-27
First Post:
2013-03-18
Brief Title:
Contingency Management Treatment for Crack Addiction - Study With Brazilian Population
Sponsor:
Federal University of São Paulo
Organization:
Federal University of São Paulo
Study Overview
Official Title:
Evaluating the Efficacy of Including Contingency Management to Standard Ambulatory Treatment for Crack Addiction - A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 STCM 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 STCM will stay longer in treatment have more negative tests for cocainecrack and achieve longer periods of cocainecrack abstinence when compared to patients receiving ST alone
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 STCM 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 STCM will stay longer in treatment have more negative tests for cocainecrack and achieve longer periods of cocainecrack 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None