Cocaine Related Disorders
Conditions
Keywords
Cocaine related disorders, Contingency Management, psychosocial treatment
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.
Interventions
BEHAVIORALstandard treatment
12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
BEHAVIORALST+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
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Both participants and researchers know the treatment alocations
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Current diagnose of crack addiction (DSM IV) * having used crack in the last month
Exclusion criteria
* Current psychotic disorder * Diagnose of schizophrenia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Longest Duaration of Achieved Abstinance | 12 weeks of treatment | Number of Participants with 4, 8 and 12 Weeks Continued Abstinence |
| Percentage Samples Submitted Negative for Crack Cocaine Use | 12 weeks | Proportion of samples testing negative for Crack Cocaine use |
| Number of Participants Completing 4, 8 and 12 Weeks of Treatment | 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 | 12 weeks | Treatment attendance was expressed as the total number of sessions attended during the 12 weeks of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Samples Submitted Negative for Alcohol Use | 12 weeks | Proportion of samples testing negative for alcohol use |
| Percentage Samples Submitted Negative for Marihuana Use | 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) |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Treatment standard treatment: 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo) | 32 |
| Standard Treatment Plus Contingency Management Standard treatment plus Contingence Management: 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 | 33 |
| Total | 65 |
Baseline characteristics
| Characteristic | Standard Treatment Plus Contingency Management | Standard Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 32 Participants | 65 Participants |
| Age, Continuous | 35.3 years STANDARD_DEVIATION 8.7 | 35.4 years STANDARD_DEVIATION 8.5 | 35.3 years STANDARD_DEVIATION 8.6 |
| Region of Enrollment Brazil | 33 participants | 32 participants | 65 participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Male | 30 Participants | 26 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 33 |
| other Total, other adverse events | 0 / 32 | 0 / 33 |
| serious Total, serious adverse events | 0 / 32 | 0 / 33 |
Outcome results
Primary
Longest Duaration of Achieved Abstinance
Number of Participants with 4, 8 and 12 Weeks Continued Abstinence
Time frame: 12 weeks of treatment
Population: Longest duaration of abstinance was determined by the highest amount of consecutive negative crack/cocaine samples submitted.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard Treatment | Longest Duaration of Achieved Abstinance | 12 weeks of abstinance | 0 number of participants |
| Standard Treatment | Longest Duaration of Achieved Abstinance | 8 weeks of abstinance | 1 number of participants |
| Standard Treatment | Longest Duaration of Achieved Abstinance | 4 weeks of abstinance | 1 number of participants |
| Standard Treatment Plus Contingency Management | Longest Duaration of Achieved Abstinance | 12 weeks of abstinance | 7 number of participants |
| Standard Treatment Plus Contingency Management | Longest Duaration of Achieved Abstinance | 8 weeks of abstinance | 8 number of participants |
| Standard Treatment Plus Contingency Management | Longest Duaration of Achieved Abstinance | 4 weeks of abstinance | 12 number of participants |
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.
Time frame: Number of participant retained in treatment at weeks 4, 8 and 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard Treatment | Number of Participants Completing 4, 8 and 12 Weeks of Treatment | Retained in week 12 | 0 number of participants |
| Standard Treatment | Number of Participants Completing 4, 8 and 12 Weeks of Treatment | Retained in week 8 | 8 number of participants |
| Standard Treatment | Number of Participants Completing 4, 8 and 12 Weeks of Treatment | Retained in week 4 | 11 number of participants |
| Standard Treatment Plus Contingency Management | Number of Participants Completing 4, 8 and 12 Weeks of Treatment | Retained in week 12 | 17 number of participants |
| Standard Treatment Plus Contingency Management | Number of Participants Completing 4, 8 and 12 Weeks of Treatment | Retained in week 8 | 21 number of participants |
| Standard Treatment Plus Contingency Management | Number of Participants Completing 4, 8 and 12 Weeks of Treatment | Retained in week 4 | 22 number of participants |
Primary
Percentage Samples Submitted Negative for Crack Cocaine Use
Proportion of samples testing negative for Crack Cocaine use
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Treatment | Percentage Samples Submitted Negative for Crack Cocaine Use | 8.3 percentage of submitted negative samples |
| Standard Treatment Plus Contingency Management | Percentage Samples Submitted Negative for Crack Cocaine Use | 46.5 percentage of submitted negative samples |
Primary
Treatment Attendance
Treatment attendance was expressed as the total number of sessions attended during the 12 weeks of treatment.
Time frame: 12 weeks
Population: we compared group means for the total number of attended sessions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Treatment | Treatment Attendance | 3.7 attended treatment sessions | Standard Deviation 5.9 |
| Standard Treatment Plus Contingency Management | Treatment Attendance | 19.5 attended treatment sessions | Standard Deviation 14.9 |
Secondary
Percentage Samples Submitted Negative for Alcohol Use
Proportion of samples testing negative for alcohol use
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Treatment | Percentage Samples Submitted Negative for Alcohol Use | 9.4 percent of sample |
| Standard Treatment Plus Contingency Management | Percentage Samples Submitted Negative for Alcohol Use | 53.9 percent of sample |
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)
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Treatment | Percentage Samples Submitted Negative for Marihuana Use | 9.8 percent of sample |
| Standard Treatment Plus Contingency Management | Percentage Samples Submitted Negative for Marihuana Use | 50.3 percent of sample |