Effectiveness of Contingency Management in the Treatment of Crack Addiction in Brazil

• Sponsor: Federal University of São Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT03345394
• Collaborator: Washington State University (Other)
• Enrollment: 98
• Location: 1
• Arms: 2
• Actual Duration (Months): 36
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Substance Use Disorders; Contingency Management; Addiction, Cocaine	Behavioral: Contingency Management; Behavioral: Standard treatment	N/A

Detailed Description

The objective of this study is to evaluate the effectiveness of Contingency Management (CM) for crack users living in the "Crackland" region. To achieve this goal, regular treatment staff from Unidade Recomeço Helvétia treatment service will be capacitated in CM to latter-on apply the CM intervention in their respective services. The design will be a single-blind randomized clinical trial composed of a sample of 100 subjects with current diagnose for crack/cocaine dependence. Participants allocated to the control condition will receive 12 weeks of the usual care treatment provided by these two treatment facilities. Participants allocated to the experimental condition will receive the exact same treatment as control participants associated with CM. CM procedure will occur 2 timer per week (every Monday and Thursday or Tuesday and Friday). Primary outcomes are: (1)retention in treatment; (2) reduction of crack use; (3) promotion of continuous crack cocaine abstinence. Secondary findings are reduction on psychiatric symptomatology. The investigator hypothesis is that participants in the CM condition will have a better treatment response in all studied outcomes.

Study Design

• Study Type: Interventional
• Actual Enrollment: 98 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Single-blind randomized controlled trialSingle-blind randomized controlled trial
• Masking: Single (Investigator)
• Masking Description: researchers had no contact with participants during the 12 week trial
• Primary Purpose: Treatment
• Official Title: Effectiveness of Contingency Management in the Treatment of Crack Addiction for Individuals Living in the "Crackland" Region. A Single-blind Randomized Controlled Trial
• Actual Study Start Date: Dec 1, 2017
• Actual Primary Completion Date: Dec 1, 2020
• Actual Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard Treatment 12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program	Behavioral: Standard treatment; Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program
Experimental: Contingency Management 12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management	Behavioral: Contingency Management; Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples

Outcome Measures

Primary Outcome Measures

1. Pattern of Crack Cocaine Use [12 weeks]

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

2. Promotion of Continuous Crack Cocaine Abstinence [12 weeks]

   Longest duration of continuous abstinence achieved (in weeks)

Secondary Outcome Measures

1. Treatment Retention [12 weeks]

   time elapsed between treatment entry and last time present in treatment (in weeks)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• DSM-V diagnose for crack cocaine use disorder

Exclusion Criteria:

• being under 18 years old

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Unidade Recomeço Helvétia	São Paulo	Sao Paulo	Brazil	01215-010

Sponsors and Collaborators

• Federal University of São Paulo
• Washington State University

Investigators

• Principal Investigator: Andre M de Queiroz Constantino Miguel, PhD, Federal University of Sao Paulo

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 5, 2018

More Information

Publications

None provided.

• Responsible Party: André de Queiroz Constantino Miguel, Principal Investigator, Federal University of São Paulo
• ClinicalTrials.gov Identifier: NCT03345394
• Other Study ID Numbers: FAPESP 2017/05371-8
• First Posted: Nov 17, 2017
• Last Update Posted: Apr 8, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by André de Queiroz Constantino Miguel, Principal Investigator, Federal University of São Paulo: crack cocaine; contingency management; ambulatory treatment; Brazil
• Additional relevant MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders; Behavior, Addictive

Study Results

Participant Flow

Arm/Group Title	Standard Treatment	Contingency Management
Arm/Group Description	12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program Standard treatment: Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program	12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management Contingency Management: Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples
Period Title: Overall Study
STARTED	48	50
COMPLETED	48	50
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Standard Treatment	Contingency Management	Total
Arm/Group Description	12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program Standard treatment: Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program	12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management Contingency Management: Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples	Total of all reporting groups
Overall Participants	48	50	98
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.2 (9.2)	37.2 (9)	38.7 (9.5)
Sex: Female, Male (Count of Participants)
Female	8 16.7%	7 14%	15 15.3%
Male	40 83.3%	43 86%	83 84.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 2.1%	1 2%	2 2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	26 54.2%	27 54%	53 54.1%
White	21 43.8%	22 44%	43 43.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
Brazil	48 100%	50 100%	98 100%
Negative urine exam at baseline (Count of Participants)
Count of Participants [Participants]	28 58.3%	22 44%	50 51%

Outcome Measures

1. Primary Outcome

Title	Pattern of Crack Cocaine Use
Description	Percentage of negative crack cocaine urine samples submitted during the 12 weeks of treatment
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

all enrolled participants were analyzed (intention to treat)

Arm/Group Title	Standard Treatment	Contingency Management
Arm/Group Description	12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program Standard treatment: Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program	12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management Contingency Management: Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples
Measure Participants	48	50
Mean (Standard Deviation) [percent of negative cocaine samples]	14.3 (4.6)	40.7 (5.8)

2. Primary Outcome

Title	Promotion of Continuous Crack Cocaine Abstinence
Description	Longest duration of continuous abstinence achieved (in weeks)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

all participants enrolled in the study were analyzed (intention to treat)

Arm/Group Title	Standard Treatment	Contingency Management
Arm/Group Description	12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program Standard treatment: Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program	12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management Contingency Management: Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples
Measure Participants	48	50
Mean (Standard Deviation) [weeks]	1.5 (3.4)	4.35 (4.7)

3. Secondary Outcome

Title	Treatment Retention
Description	time elapsed between treatment entry and last time present in treatment (in weeks)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

all participants enrolled in the study where analyzed (intention to treat)

Arm/Group Title	Standard Treatment	Contingency Management
Arm/Group Description	12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program Standard treatment: Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program	12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management Contingency Management: Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples
Measure Participants	48	50
Mean (Standard Deviation) [weeks]	3.4 (4.8)	7 (5.2)

Adverse Events

Time Frame	12 weeks
Adverse Event Reporting Description	Because this study did not include a pharmacological intervention, the only adverse event information collected was mortality.
Arm/Group Title	Standard Treatment		Contingency Management
Arm/Group Description	12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program Standard treatment: Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program		12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management Contingency Management: Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples
All Cause Mortality
	Standard Treatment		Contingency Management
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/50 (0%)
Serious Adverse Events
	Standard Treatment		Contingency Management
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Standard Treatment		Contingency Management
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.