Sociodemographic profile and natural history of crack use among users of different Brazilian states
| ISRCTN | ISRCTN33967634 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33967634 |
| Protocol serial number | CAAE 00559212.1.0000.5505 Opinion number 434882 |
| Sponsor | National Council for Scientific and Technological Development (Cnpq) |
| Funder | National Council for Scientific and Technological Development (CNPq) |
- Submission date
- 07/08/2017
- Registration date
- 22/07/2019
- Last edited
- 08/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
In Brazil, crack cocaine was initially restricted to the city of Sao Paulo, later spreading to the whole country during the 90's and 2000’s. During these two decades, governmental efforts were established, creating the biggest substance use disorders program in Latin America. Studies were conducted in 1996 to 1997 and 2012 to 2013 to investigate patterns of consumption, severity of dependence and cocaine-related problems among snorted and smoked cocaine users in Sao Paulo, Brazil. This study aims to compare the characteristics of crack cocaine users seeking treatment in 1996 to 1997 and 2012 to 2013.
Who can participate?
Crack cocaine users who started treatment during the period of the study in drug treatment programs in six states of Brazil and the Federal District
What does the study involve?
Participants are interviewed to examine their sociodemographic characteristics and patterns of drug use (i.e., age, gender, marital status, educational level and family composition, crack cocaine use, time since first use, frequency of crack use, company of use, job problems related to crack cocaine, arresting, treatment).
What are the possible benefits and risks of participating?
The benefits of participating include improving knowledge about crack use and providing scientific evidence to create treatment models and public policies aimed at these users. There are no risks of participating.
Where is the study run from?
Alcohol and Drugs Research Unit (Brazil)
When is the study starting and how long is it expected to run for?
January 2012 to January 2014
Who is funding the study?
National Council for Scientific and Technological Development (Cnpq)
Who is the main contact?
Miss Luciane Perrenoud
lucianeogataperrenoud@gmail.com
Contact information
Scientific
Street Borges da Lagoa, 570, Floor 8o, CJ 82 - Vila Clementino
São Paulo - SP
04038-000
Brazil
| Phone | +55 (0) 11 997474321 |
|---|---|
| marcelorabr@gmail.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Two cross-sectional studies conducted in 1996 to 1997 (N=133) and 2012 to 2013 (N=577) investigating characteristics of crack cocaine users |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | Twenty-five years of crack cocaine use in Brazil: changes on user’s profile who are seeking help This study, involving multiple Brazilian regions, aimed to compare the profile of crack cocaine users seeking treatment sixteen years apart. |
| Study objectives | To compare the profile of crack cocaine users seeking treatment sixteen years apart (1996 - 2012) investigating sociodemographic characteristics and pattern of crack cocaine use. |
| Ethics approval(s) | Ethics Committee of the Federal University of São Paulo, 05/04/2013, ref: Version 4 CAAE 00559212.1.0000.5505 Opinion number 434882 |
| Health condition(s) or problem(s) studied | Severity of dependence and cocaine-related problems |
| Intervention | These are two cross-sectional studies conducted in 1996 to 1997 and 2012 to 2013 to investigate patterns of consumption, severity of dependence and cocaine-related problems among snorted and smoked cocaine users in Sao Paulo, Brazil, with its results published elsewhere. The original study interviewed regular crack-cocaine users (at least twice a week for the previous three months). Subjects were recruited from public and private clinics (n=382). For comparisons with the present study, the trialists selected only those who were aged 18 and above, use to smoke cocaine as their main route of administration, were in treatment at the time of the interview and were not living on the streets (final sample=133). Data was collected in drug treatment programs in six Brazilian States and the Federal District. 133 individuals were interviewed in 1996 and 577 in 2012. The Intake Questionnaire and the Maudsley Addiction Profile was used as a basis for the interviews to examine sociodemographic characteristics and patterns of drug use. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Sociodemographic profile |
| Key secondary outcome measure(s) |
Severity of dependence and cocaine-related problems, measured using structured interview based on the Intake Questionnaire and the Maudsley Addiction Profile (MAP) in 1996 and 2012 |
| Completion date | 01/01/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 577 |
| Total final enrolment | 577 |
| Key inclusion criteria | 1. A sample of 20 therapeutic communities was selected in six states of Brazil and the Federal District. All of them were in accordance with the operating standards of the Brazilian Federation of Therapeutic Communities (FEBRACT) and with the health safety requirements for the operation this type of institutions, provided by the National Health Surveillance Agency (RDC Nº29/2001, ANVISA) 2. All crack cocaine users who initiated treatment between the referred period where invited to participate in the study |
| Key exclusion criteria | Patients living on the streets were excluded from the final sample |
| Date of first enrolment | 01/09/2012 |
| Date of final enrolment | 01/09/2013 |
Locations
Countries of recruitment
- Brazil
Study participating centre
São Paulo - SP
04038-000
Brazil
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in repository |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publically available repository, Open Science Framework (https://osf.io). Type of data that will be shared: Sample questionnaire and database. When the data will become available: Already available. How long: Undetermined time. By what access criteria the data will be shared: Free access by weblink. With whom: for now only with researchers involved in the study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Comparison of 1997 and 2013 users | 01/12/2019 | 08/09/2021 | Yes | No |
| Results article | Factors association with early initiation of crack use | 23/04/2021 | 08/09/2021 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
08/09/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
