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
Verified date | July 2017 |
Source | Federal University of São Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Ambulatorio Medico de Especialidades (AME) da Vila Maria | Sao Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo | Fundação de Amparo à Pesquisa do Estado de São Paulo |
Brazil,
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
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 |
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