Condition category
Mental and Behavioural Disorders
Date applied
07/08/2017
Date assigned
22/07/2019
Last edited
22/07/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.cnpq.br

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

Publication citations

Additional files

Editorial Notes