NCT03345394

Brief Summary

Crack addiction has become a severe public health problem in Brazil. Crack users present elevated prevalence rates of psychiatric comorbidities, sexual transmitted infections and unemployment with high probability of living or have lived in the streets, history of incarceration and engagement in illegal activities. For the last 20 years a treatment called Contingency Management (CM) have achieved the best results regarding reduction of substance use, promotion of abstinence, treatment attendance and retention in treatment. The first CM study conducted in Brazil advocates for the efficacy of CM on all of these outcomes, suggesting that CM can be effective in a Brazilian population of crack users.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
4 months until next milestone

Results Posted

Study results publicly available

April 8, 2021

Completed
Last Updated

April 8, 2021

Status Verified

March 1, 2021

Enrollment Period

3 years

First QC Date

November 14, 2017

Results QC Date

January 7, 2021

Last Update Submit

March 16, 2021

Conditions

Keywords

crack cocainecontingency managementambulatory treatmentBrazil

Outcome Measures

Primary Outcomes (2)

  • Pattern of Crack Cocaine Use

    Percentage of negative crack cocaine urine samples submitted during the 12 weeks of treatment

    12 weeks

  • Promotion of Continuous Crack Cocaine Abstinence

    Longest duration of continuous abstinence achieved (in weeks)

    12 weeks

Secondary Outcomes (1)

  • Treatment Retention

    12 weeks

Study Arms (2)

Standard Treatment

ACTIVE COMPARATOR

12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program

Behavioral: Standard treatment

Contingency Management

EXPERIMENTAL

12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management

Behavioral: Contingency Management

Interventions

Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples

Contingency Management

Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program

Standard Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DSM-V diagnose for crack cocaine use disorder

You may not qualify if:

  • being under 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unidade Recomeço Helvétia

São Paulo, São Paulo, 01215-010, Brazil

Location

MeSH Terms

Conditions

Substance-Related DisordersCocaine-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Dr. André Miguel
Organization
Federal University of Sao Paulo

Study Officials

  • Andre M de Queiroz Constantino Miguel, PhD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
researchers had no contact with participants during the 12 week trial
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single-blind randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 14, 2017

First Posted

November 17, 2017

Study Start

December 1, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

April 8, 2021

Results First Posted

April 8, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations