Trial Outcomes & Findings for A Bridge to Treatment: The Therapeutic Workplace and Methadone Treatment (NCT NCT01416584)

Results Overview

The percentage of months in which participants were enrolled in methadone treatment during the 6-month intervention evaluation period?

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

98 participants

Primary outcome timeframe

6 months

Results posted on

2017-12-05

Participant Flow

Participants were recruited through agencies that served the target population, street outreach, and a respondent-driven sampling referral system in which study participants were paid for successfully referring others to the study. Interested individuals completed a brief screening interview that gauged study eligibility.

Eligible participants were invited to participate in a 4-week induction. During induction, participants were invited to attend the therapeutic workplace. Participants who attended the workplace for at least five minutes on two out of five workdays in the last week of induction were randomly assigned to one of three conditions.

Participant milestones

Participant milestones
Measure	Usual Care Control Participants in this group were offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They were offered the methadone treatment but are not required to join in order to gain access to the workplace.	Methadone Contingency Group Participants in this group were allowed to work and earn wages as long as they enrolled in the methadone treatment and continued to take does of methadone consistently.	Methadone & Abstinence Contingency Participants were be able to access work if they enroll in the methadone treatment and consistently take their medication, but also received a decrease in base pay if they test positive for opiates or cocaine on the drug screens.
Overall Study STARTED	30	35	33
Overall Study COMPLETED	27	33	32
Overall Study NOT COMPLETED	3	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Bridge to Treatment: The Therapeutic Workplace and Methadone Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care Control n=30 Participants Participants in this group will be offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They will be offered the methadone treatment but are not required to join in order to gain access to the workplace.	Methadone Contingency Group n=35 Participants Participants in this group will only be allowed to work and earn wages as long as they enroll in the methadone treatment and continue to take does of methadone consistently.	Methadone & Abstinence Contingency n=33 Participants Participants will only be able to access work if they enroll in the methadone treatment and consistently take their medication, but also will receive a decrease in base pay if they test positive for opiates or cocaine on the drug screens.	Total n=98 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	34 Participants n=7 Participants	33 Participants n=5 Participants	97 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Age, Continuous	44 years STANDARD_DEVIATION 9 • n=5 Participants	42 years STANDARD_DEVIATION 10 • n=7 Participants	44 years STANDARD_DEVIATION 9 • n=5 Participants	44 years STANDARD_DEVIATION 9 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants	33 Participants n=4 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	27 Participants n=7 Participants	18 Participants n=5 Participants	65 Participants n=4 Participants
Region of Enrollment United States	30 participants n=5 Participants	35 participants n=7 Participants	33 participants n=5 Participants	98 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Intent to treat

The percentage of months in which participants were enrolled in methadone treatment during the 6-month intervention evaluation period?

Outcome measures

Outcome measures
Measure	Usual Care Control n=30 Participants Participants in this group were offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They were offered the methadone treatment but were not required to join in order to gain access to the workplace.	Methadone Contingency Group n=35 Participants Participants in this group were allowed to work and earn wages as long as they enrolled in the methadone treatment and continued to take does of methadone consistently.	Methadone & Abstinence Contingency n=33 Participants Participants in this group were able to access work if they enrolled in the methadone treatment and consistently took their medication, but they also received a decrease in base pay if they test positive for opiates or cocaine on the drug screens.
Percentage of Months in Methadone Treatment	81 percent of months in methadone treatment Interval 0.0 to 100.0	82 percent of months in methadone treatment Interval 0.0 to 100.0	88 percent of months in methadone treatment Interval 0.0 to 100.0

PRIMARY outcome

Timeframe: 6 months

Population: Intent to treat

Percentage of urine sample negative for opiates at each of the six 30-day assessments scheduled throughout the intervention evaluation

Outcome measures

Outcome measures
Measure	Usual Care Control n=30 Participants Participants in this group were offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They were offered the methadone treatment but were not required to join in order to gain access to the workplace.	Methadone Contingency Group n=35 Participants Participants in this group were allowed to work and earn wages as long as they enrolled in the methadone treatment and continued to take does of methadone consistently.	Methadone & Abstinence Contingency n=33 Participants Participants in this group were able to access work if they enrolled in the methadone treatment and consistently took their medication, but they also received a decrease in base pay if they test positive for opiates or cocaine on the drug screens.
Percentage of Monthly Urine Sample Negative for Opiates	54 percentage of opiate negative Interval 0.0 to 100.0	61 percentage of opiate negative Interval 0.0 to 100.0	75 percentage of opiate negative Interval 0.0 to 100.0

PRIMARY outcome

Timeframe: 6 months

Population: intent to treat

Was the participant's urine sample negative for cocaine at each of the six 30-day assessments scheduled throughout the intervention evaluation period?

Outcome measures

Outcome measures
Measure	Usual Care Control n=30 Participants Participants in this group were offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They were offered the methadone treatment but were not required to join in order to gain access to the workplace.	Methadone Contingency Group n=35 Participants Participants in this group were allowed to work and earn wages as long as they enrolled in the methadone treatment and continued to take does of methadone consistently.	Methadone & Abstinence Contingency n=33 Participants Participants in this group were able to access work if they enrolled in the methadone treatment and consistently took their medication, but they also received a decrease in base pay if they test positive for opiates or cocaine on the drug screens.
Percentage of Monthly Urine Samples Negative for Cocaine	32 percentage of cocaine negative Interval 0.0 to 100.0	55 percentage of cocaine negative Interval 0.0 to 100.0	57 percentage of cocaine negative Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: 6 months

Population: intent to treat

Was each participant's urine sample negative for cocaine at each of the Monday, Wednesday, Friday urine samples scheduled throughout the intervention evaluation period?

Outcome measures

Outcome measures
Measure	Usual Care Control n=30 Participants Participants in this group were offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They were offered the methadone treatment but were not required to join in order to gain access to the workplace.	Methadone Contingency Group n=35 Participants Participants in this group were allowed to work and earn wages as long as they enrolled in the methadone treatment and continued to take does of methadone consistently.	Methadone & Abstinence Contingency n=33 Participants Participants in this group were able to access work if they enrolled in the methadone treatment and consistently took their medication, but they also received a decrease in base pay if they test positive for opiates or cocaine on the drug screens.
Percentage of M,W,F Urine Samples Negative for Cocaine	25 percentage of urine samples Interval 3.8 to 100.0	44 percentage of urine samples Interval 0.0 to 100.0	48 percentage of urine samples Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: 6 months

Population: intent to treat

Was each participant's urine sample negative for opiates at each of the Monday, Wednesday, Friday urine samples scheduled throughout the intervention evaluation period?

Outcome measures

Outcome measures
Measure	Usual Care Control n=30 Participants Participants in this group were offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They were offered the methadone treatment but were not required to join in order to gain access to the workplace.	Methadone Contingency Group n=35 Participants Participants in this group were allowed to work and earn wages as long as they enrolled in the methadone treatment and continued to take does of methadone consistently.	Methadone & Abstinence Contingency n=33 Participants Participants in this group were able to access work if they enrolled in the methadone treatment and consistently took their medication, but they also received a decrease in base pay if they test positive for opiates or cocaine on the drug screens.
Percentage of M,W,F Urine Samples Negative for Opiates	43 percentage of M,W,F urine samples Interval 3.8 to 100.0	50 percentage of M,W,F urine samples Interval 0.0 to 100.0	65 percentage of M,W,F urine samples Interval 0.0 to 100.0

Adverse Events

Usual Care Control

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Methadone Contingency Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Methadone & Abstinence Contingency

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Usual Care Control n=30 participants at risk Participants in this group will be offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They will be offered the methadone treatment but are not required to join in order to gain access to the workplace.	Methadone Contingency Group n=35 participants at risk Participants in this group will only be allowed to work and earn wages as long as they enroll in the methadone treatment and continue to take does of methadone consistently.	Methadone & Abstinence Contingency n=33 participants at risk Participants will only be able to access work if they enroll in the methadone treatment and consistently take their medication, but also will receive a decrease in base pay if they test positive for opiates or cocaine on the drug screens.
General disorders Hospitalization for car accident	3.3% 1/30 • Number of events 1 • 7 months	0.00% 0/35 • 7 months	0.00% 0/33 • 7 months
Reproductive system and breast disorders Hospitalization for Vaginal Swelling	0.00% 0/30 • 7 months	0.00% 0/35 • 7 months	3.0% 1/33 • Number of events 1 • 7 months

Other adverse events

Other adverse events
Measure	Usual Care Control n=30 participants at risk Participants in this group will be offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They will be offered the methadone treatment but are not required to join in order to gain access to the workplace.	Methadone Contingency Group n=35 participants at risk Participants in this group will only be allowed to work and earn wages as long as they enroll in the methadone treatment and continue to take does of methadone consistently.	Methadone & Abstinence Contingency n=33 participants at risk Participants will only be able to access work if they enroll in the methadone treatment and consistently take their medication, but also will receive a decrease in base pay if they test positive for opiates or cocaine on the drug screens.
General disorders Dizziness	0.00% 0/30 • 7 months	2.9% 1/35 • Number of events 1 • 7 months	0.00% 0/33 • 7 months
General disorders Inpatient heroin detoxification	0.00% 0/30 • 7 months	2.9% 1/35 • Number of events 1 • 7 months	0.00% 0/33 • 7 months

Additional Information

Kenneth Silverman

Johns Hopkins University School of Medicine

Phone: 410-550-2694

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place