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| Name | Class |
|---|---|
| Washington State University | OTHER |
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Crack addiction has become a severe public health problem in Brazil. Crack users present elevated prevalence rates of psychiatric comorbidities, sexual transmitted infections and unemployment with high probability of living or have lived in the streets, history of incarceration and engagement in illegal activities. For the last 20 years a treatment called Contingency Management (CM) have achieved the best results regarding reduction of substance use, promotion of abstinence, treatment attendance and retention in treatment. The first CM study conducted in Brazil advocates for the efficacy of CM on all of these outcomes, suggesting that CM can be effective in a Brazilian population of crack users.
The objective of this study is to evaluate the effectiveness of Contingency Management (CM) for crack users living in the "Crackland" region. To achieve this goal, regular treatment staff from Unidade Recomeço Helvétia treatment service will be capacitated in CM to latter-on apply the CM intervention in their respective services. The design will be a single-blind randomized clinical trial composed of a sample of 100 subjects with current diagnose for crack/cocaine dependence. Participants allocated to the control condition will receive 12 weeks of the usual care treatment provided by these two treatment facilities. Participants allocated to the experimental condition will receive the exact same treatment as control participants associated with CM. CM procedure will occur 2 timer per week (every Monday and Thursday or Tuesday and Friday). Primary outcomes are: (1)retention in treatment; (2) reduction of crack use; (3) promotion of continuous crack cocaine abstinence. Secondary findings are reduction on psychiatric symptomatology. The investigator hypothesis is that participants in the CM condition will have a better treatment response in all studied outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Treatment | Active Comparator | 12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program |
|
| Contingency Management | Experimental | 12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contingency Management | Behavioral | Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pattern of Crack Cocaine Use | Percentage of negative crack cocaine urine samples submitted during the 12 weeks of treatment | 12 weeks |
| Promotion of Continuous Crack Cocaine Abstinence | Longest duration of continuous abstinence achieved (in weeks) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Retention | time elapsed between treatment entry and last time present in treatment (in weeks) | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andre M de Queiroz Constantino Miguel, PhD | Federal University of São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidade Recomeço Helvétia | São Paulo | São Paulo | 01215-010 | Brazil |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Treatment | 12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program Standard treatment: Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program |
| FG001 | Contingency Management | 12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management Contingency Management: Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
all participants enrolled in the study were analyzed (intention to treat)
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Treatment | 12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program Standard treatment: Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program |
| BG001 | Contingency Management |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pattern of Crack Cocaine Use | Percentage of negative crack cocaine urine samples submitted during the 12 weeks of treatment | all enrolled participants were analyzed (intention to treat) | Posted | Mean | Standard Deviation | percent of negative cocaine samples | 12 weeks |
|
12 weeks
Because this study did not include a pharmacological intervention, the only adverse event information collected was mortality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Treatment | 12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program Standard treatment: Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. André Miguel | Federal University of Sao Paulo | +55 11 965884111 | aqcmiguel@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 5, 2018 | Feb 5, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D019970 | Cocaine-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Single-blind randomized controlled trial
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researchers had no contact with participants during the 12 week trial
| Standard treatment | Behavioral | Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program |
|
12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management Contingency Management: Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Negative urine exam at baseline | Count of Participants | Participants |
|
|
|
| Primary | Promotion of Continuous Crack Cocaine Abstinence | Longest duration of continuous abstinence achieved (in weeks) | all participants enrolled in the study were analyzed (intention to treat) | Posted | Mean | Standard Deviation | weeks | 12 weeks |
|
|
|
| Secondary | Treatment Retention | time elapsed between treatment entry and last time present in treatment (in weeks) | all participants enrolled in the study where analyzed (intention to treat) | Posted | Mean | Standard Deviation | weeks | 12 weeks |
|
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|
| 0 |
| 48 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Contingency Management | 12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management Contingency Management: Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples | 0 | 50 | 0 | 0 | 0 | 0 |
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