Crack Abuse or DependenceNCT01558726
Case Management for Crack Users Who Seek Treatment in CAPSad in Brazil
A study testing Case Management (Strength-Based) and Usual Treatment in people with Crack Abuse or Dependence, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the effectiveness of a Case Management (CM) intervention in crack users applied in Psychosocial Care Centers - Alcohol and Drugs (CAPSad) by trained social workers, in comparison to CAPSad conventional treatment on 30 and 90 days, considering the following outcomes: treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crack Abuse or Dependence
- What is being tested?
- Case Management (Strength-Based) and Usual Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of crack abuse or dependence
- > 18 years old
- Initiating treatment (maximum of 1 month)
Who cannot join
- Homeless without permanent contact
- Psychotic symptoms during the intake interview
Trial locations and contacts
1 site in 1 country.
Felix HP Kessler, PhD contact
Brazil1 site, 1 recruiting
- Recruiting
Center for Drug and Alcohol Research (CPAD) of Federal University of Rio Grande do Sul (UFRGS)
Porto Alegre, Rio Grande do Sul, 90035-903
Flavio Pechansky, PhD, 55-51-3359-7480, fpechans@uol.com.br
Felix HP Kessler, PhD, 55-51-3359-7480, kessler.ez@terra.com.br
About this study
Official title: Effectiveness of Case Management for Crack Users Who Seek Treatment in CAPSad in Six Brazilian Capitals
The purpose of this study is to evaluate the effectiveness of a Case Management (CM) intervention in crack users applied in Psychosocial Care Centers - Alcohol and Drugs (CAPSad) by trained social workers, in comparison to CAPSad conventional treatment on 30 and 90 days, considering the following outcomes: treatment retention, abstinence and changes in severity scores of the sixth version of Addiction Severity Index (ASI6) scale. The study hypothesis are: 1) The CM is going to improve the retention of crack users (cases) during the 3-month follow-up compared with usual care (controls); 2)Individuals who received the intervention with GC are going to present a higher rate of abstinence; 3)The summary scores of the ASI6 will be significantly lower in cases than in controls, at the end of 3 months follow-up.
- Conditions
- Crack Abuse or Dependence
- Being tested
- Case Management (Strength-Based), Usual Treatment
- Keywords
- Case Management, Crack abuse/dependents, Evaluation, Inpatient, ASI, Treatment retention, Abstinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case Management (Strength-Based)Behavioural
To improve the cases sharing between CAPSad and other health institutions and individuals and increase the strengths of the patient to cope with problems related to the crack use.
Usual TreatmentBehavioural
The usual treatment used for regular patients of CAPSad
| Study group | Role | What they receive |
|---|---|---|
| Case management | Experimental | Not described Receives: Behavioral: Case Management (Strength-Based) |
| Usual treatment | Active comparator | Usual treatment of the CAPSad Receives: Behavioral: Usual Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment retention
Measured: 3 months
Secondary outcomes (2)
Crack abstinence
Measured: 3 months
ASI subareas scores
ASI (Addiction Severity Index)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startOct 2011
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crack Abuse or DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Clinicas de Porto Alegre, Brazilian Secretariat for Drug Policies (SENAD), Federal University of Bahia, Federal University of Espirito Santo, Universidade Federal do Rio de Janeiro, Faculdade de Medicina do ABC, University of Brasilia
- Responsible party
- Principal investigator, Professor Flavio Pechansky, Federal University of Rio Grande do Sul
- Investigators
- Flavio Pechansky, PhD, Principal investigator, Center for Drug and Alcohol Research (CPAD) of Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558726
- Sponsor's protocol ID
- 10-0176
- Status last verified
- Mar 2012
- First submitted
- 17 Mar 2012
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Case Management for Crack Users Who Seek Treatment in CAPSad in Six Brazilian Capitals
- ClinicalTrials.gov ID
- NCT01558726
- Acronym / sponsor ID
- 10-0176
- Conditions
- Crack Abuse or Dependence
- Keywords
- Case Management, Crack abuse/dependents, Evaluation, Inpatient, ASI, Treatment retention, Abstinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- Hospital de Clinicas de Porto Alegre, Brazilian Secretariat for Drug Policies (SENAD), Federal University of Bahia, Federal University of Espirito Santo, Universidade Federal do Rio de Janeiro, Faculdade de Medicina do ABC, University of Brasilia
- Study start
- Oct 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 20 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of a Case Management (CM) intervention in crack users applied in Psychosocial Care Centers - Alcohol and Drugs (CAPSad) by trained social workers, in comparison to CAPSad conventional treatment on 30 and 90 days, considering the following outcomes: treatment retention, abstinence and changes in severity scores of the sixth version of Addiction Severity Index (ASI6) scale. The study hypothesis are: 1) The CM is going to improve the retention of crack users (cases) during the 3-month follow-up compared with usual care (controls); 2)Individuals who received the intervention with GC are going to present a higher rate of abstinence; 3)The summary scores of the ASI6 will be significantly lower in cases than in controls, at the end of 3 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case management | Experimental | Behavioral: Case Management (Strength-Based) |
| Usual treatment | Active comparator | Behavioral: Usual TreatmentUsual treatment of the CAPSad |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of crack abuse or dependence
- > 18 years old
- Initiating treatment (maximum of 1 month)
Key exclusion criteria (2 listed)
- Homeless without permanent contact
- Psychotic symptoms during the intake interview
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case Management (Strength-Based)To improve the cases sharing between CAPSad and other health institutions and individuals and increase the strengths of the patient to cope with problems related to the crack use. | Behavioural | Case management |
| Usual TreatmentThe usual treatment used for regular patients of CAPSad | Behavioural | Usual treatment |
Primary outcome
Treatment retention
Time frame: 3 months
2 secondary outcomes
Crack abstinence
Time frame: 3 months
ASI subareas scores
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felix HP Kessler, PhD contact
Flavio Pechansky, PhD principal investigator
Center for Drug and Alcohol Research (CPAD) of Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case Management (Strength-Based) and Usual Treatment in people with Crack Abuse or Dependence, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Flavio Pechansky, PhD (55-51-3359-7480, fpechans@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment retention (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2012.