Contingency Management Treatment for Crack Addiction - Study With Brazilian Population

Cocaine Related Disorders Clinical Trial

Official title:

Evaluating the Efficacy of Including Contingency Management to Standard Ambulatory Treatment for Crack Addiction - A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01815645
• Other study ID #: 2011/01469-7 (FAPESP)
• Status: Completed
• Phase: N/A
• First received: March 18, 2013
• Last updated: July 26, 2017
• Start date: May 2012
• Est. completion date: June 2015

Study information

• Verified date: July 2017
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Current diagnose of crack addiction (DSM IV)

• having used crack in the last month

Exclusion Criteria:

• Current psychotic disorder

• Diagnose of schizophrenia

Related Conditions & MeSH terms

• Cocaine Related Disorders
• Cocaine-Related Disorders

Intervention

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
• standard treatment
12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)

Locations

Country	Name	City	State
Brazil	Ambulatorio Medico de Especialidades (AME) da Vila Maria	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Miguel AQ, Madruga CS, Cogo-Moreira H, Yamauchi R, Simões 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. Epub 2016 Jul 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Longest Duaration of Achieved Abstinance	Number of Participants with 4, 8 and 12 Weeks Continued Abstinence	12 weeks of treatment
Primary	Percentage Samples Submitted Negative for Crack Cocaine Use	Proportion of samples testing negative for Crack Cocaine use	12 weeks
Primary	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.	Number of participant retained in treatment at weeks 4, 8 and 12.
Primary	Treatment Attendance	Treatment attendance was expressed as the total number of sessions attended during the 12 weeks of treatment.	12 weeks
Secondary	Percentage Samples Submitted Negative for Alcohol Use	Proportion of samples testing negative for alcohol use	12 weeks
Secondary	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)	12 weeks