Sociodemographic profile and natural history of crack use among users of different Brazilian states

ISRCTN ISRCTN33967634
DOI https://doi.org/10.1186/ISRCTN33967634
Secondary identifying numbers CAAE 00559212.1.0000.5505 Opinion number 434882
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Mr Marcelo Ribeiro
Scientific

Street Borges da Lagoa, 570, Floor 8o, CJ 82 - Vila Clementino
São Paulo - SP
04038-000
Brazil

Phone +55 (0) 11 997474321
Email marcelorabr@gmail.com

Study information

Study designTwo cross-sectional studies conducted in 1996 to 1997 (N=133) and 2012 to 2013 (N=577) investigating characteristics of crack cocaine users
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleTwenty-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 objectivesTo 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) studiedSeverity of dependence and cocaine-related problems
InterventionThese 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 typeOther
Primary outcome measure1. 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 measuresSeverity 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 study start date01/01/2012
Completion date01/01/2014

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsIn total 719 participants were interviewed, from those 577 (80,2%) gave formal consent to participate and complete the whole interview.
Total final enrolment577
Key inclusion criteria1. 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 criteriaPatients living on the streets were excluded from the final sample
Date of first enrolment01/09/2012
Date of final enrolment01/09/2013

Locations

Countries of recruitment

  • Brazil

Study 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

National Council for Scientific and Technological Development (Cnpq)
Research council

SHIS QI 1 Cj B - Blocks A, B, C and D - Blue Lagoon
Brasília-DF
71605-001
Brazil

Website http://www.cnpq.br
ROR logo "ROR" https://ror.org/03swz6y49

Funders

Funder type

Research council

National Council for Scientific and Technological Development (CNPq)

No information available

Results and Publications

Intention to publish date01/08/2017
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination planThe 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 planThe 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

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.