Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Mr Marcelo Ribeiro
ORCID ID
Contact details
Street Borges da Lagoa
570
Floor 8o
CJ 82 - Vila Clementino
São Paulo - SP
04038-000
Brazil
+55 (0) 11 997474321
marcelorabr@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CAAE 00559212.1.0000.5505 Opinion number 434882
Study information
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.
Acronym
Study hypothesis
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
Ethics Committee of the Federal University of São Paulo, 05/04/2013, ref: Version 4 CAAE 00559212.1.0000.5505 Opinion number 434882
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
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measure
1. Sociodemographic profile
2. Pattern of use in crack users
Measured using structured interview based on the Intake Questionnaire and the Maudsley Addiction Profile (MAP) in 1996 and 2012
Secondary outcome measures
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
Overall trial start date
01/01/2012
Overall trial end date
01/01/2014
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
In total 719 participants were interviewed, from those 577 (80,2%) gave formal consent to participate and complete the whole interview.
Participant exclusion criteria
Patients living on the streets were excluded from the final sample
Recruitment start date
01/09/2012
Recruitment end date
01/09/2013
Locations
Countries of recruitment
Brazil
Trial participating centre
Alcohol and Drugs Research Unit
Street Borges da Lagoa, 570, Floor 8o, CJ 82 - Vila Clementino
São Paulo - SP
04038-000
Brazil
Sponsor information
Organisation
National Council for Scientific and Technological Development (Cnpq)
Sponsor details
SHIS QI 1 Cj B - Blocks A
B
C and D - Blue Lagoon
Brasília-DF
71605-001
Brazil
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
National Council for Scientific and Technological Development (CNPq)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The study protocol, statistical analysis plan and others will be able in Open Science Framework. Planned publication in a high-impact peer reviewed journal.
IPD sharing statement
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.
Intention to publish date
01/08/2017
Participant level data
Stored in repository
Basic results (scientific)
Publication list