Trial Outcomes & Findings for Effectiveness of Contingency Management in the Treatment of Crack Addiction in Brazil (NCT NCT03345394)

NCT ID: NCT03345394

Last Updated: 2021-04-08

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 98 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2021-04-08

Participant Flow

Participant milestones

Measure	Standard Treatment 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	Contingency Management 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
Overall Study STARTED	48	50
Overall Study COMPLETED	48	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Standard Treatment n=48 Participants 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	Contingency Management n=50 Participants 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 n=98 Participants Total of all reporting groups
Age, Continuous	40.2 years STANDARD_DEVIATION 9.2 • n=5 Participants	37.2 years STANDARD_DEVIATION 9 • n=7 Participants	38.7 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	43 Participants n=7 Participants	83 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	26 Participants n=5 Participants	27 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Brazil	48 Participants n=5 Participants	50 Participants n=7 Participants	98 Participants n=5 Participants
Negative urine exam at baseline	28 Participants n=5 Participants	22 Participants n=7 Participants	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: all enrolled participants were analyzed (intention to treat)

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

Outcome measures

Measure	Standard Treatment n=48 Participants 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	Contingency Management n=50 Participants 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
Pattern of Crack Cocaine Use	14.3 percent of negative cocaine samples Standard Deviation 4.6	40.7 percent of negative cocaine samples Standard Deviation 5.8

PRIMARY outcome

Timeframe: 12 weeks

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

Longest duration of continuous abstinence achieved (in weeks)

Outcome measures

Measure	Standard Treatment n=48 Participants 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	Contingency Management n=50 Participants 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
Promotion of Continuous Crack Cocaine Abstinence	1.5 weeks Standard Deviation 3.4	4.35 weeks Standard Deviation 4.7

SECONDARY outcome

Timeframe: 12 weeks

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

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

Outcome measures

Measure	Standard Treatment n=48 Participants 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	Contingency Management n=50 Participants 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
Treatment Retention	3.4 weeks Standard Deviation 4.8	7 weeks Standard Deviation 5.2

Adverse Events

Standard Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Contingency Management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. André Miguel

Federal University of Sao Paulo

Phone: +55 11 965884111

Email: aqcmiguel@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place