A Bridge to Treatment: The Therapeutic Workplace and Methadone Treatment

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01416584
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 98
• Location: 1
• Arms: 3
• Duration (Months): 66
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effectiveness of the Therapeutic Workplace in promoting methadone treatment and increasing abstinence in unemployed, out-of-treatment injection heroine users.

Condition or Disease	Intervention/Treatment	Phase
Opiate Dependence	Behavioral: methadone contingency; Behavioral: Methadone & Abstinence Contingency	N/A

Detailed Description

A randomized study is planned for 5 years to evaluate the effectiveness of the Therapeutic Workplace in promoting methadone treatment and abstinence in unemployed injection drug users. Participants will be recruited through street outreach, at agencies that serve the target populations, and informal word-of-mouth referrals. Participants will be invited to attend the workplace and to enroll in the methadone treatment. To engage participants in the workplace, they will be allowed to work independent of whether they enroll in methadone treatment and independent of their drug use. The workplace participants (N=162) will be randomly assigned to three groups. The "Usual Care Control" participants will be allowed to work independent of their methadone use or urinalysis results. The "Methadone Contingency" participants will be required to take methadone to attend work, and will receive a brief pay decrease for failing to take their medication. The "Methadone & Abstinence Contingency" participants will be required to take their medication in order to attend work, as well as receive a brief pay decrease for any positive urine samples for both cocaine and methadone.

Study Design

• Study Type: Interventional
• Actual Enrollment: 98 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Bridge to Treatment: The Therapeutic Workplace and Methadone Treatment
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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 were not required to join in order to gain access to the workplace.
Experimental: 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 (employment-based reinforcement).	Behavioral: methadone contingency; Participants had to enroll in methadone treatment and take daily doses of methadone to gain access to the workplace.
Experimental: Methadone & Abstinence Contingency 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 (employment-based reinforcement).	Behavioral: methadone contingency; Participants had to enroll in methadone treatment and take daily doses of methadone to gain access to the workplace.; Behavioral: Methadone & Abstinence Contingency; Participants had to enroll in methadone treatment and take daily doses of methadone to gain access to the workplace and they had to provide opiate and cocaine negative urine samples to maintain the maximum pay.

Outcome Measures

Primary Outcome Measures

1. Percentage of Months in Methadone Treatment [6 months]

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

2. Percentage of Monthly Urine Sample Negative for Opiates [6 months]

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

3. Percentage of Monthly Urine Samples Negative for Cocaine [6 months]

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

Secondary Outcome Measures

1. Percentage of M,W,F Urine Samples Negative for Cocaine [6 months]

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

2. Percentage of M,W,F Urine Samples Negative for Opiates [6 months]

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

Other Outcome Measures

1. Did Participant Share Needles or Works? [6 months]

   Percent of months that participants reported sharing needles or works.

2. Went to Shooting Gallery/House or Other Place Where Users go to Shoot-up? [6 months]

   The percent of months that participants reported going to a shooting gallery/hour or other place where users go to shoot-up.

3. Did Participant Inject Drugs? [6 months]

   Percent of months that participants reported injecting drugs.

4. In Methadone Treatment at End of Treatment [6 months]

   Was each participant in methadone treatment at the end of the 6-month intervention evaluation period?

5. Entered Methadone Treatment [6 months]

   Did the participant enter methadone treatment at any point in the 6-month treatment period?

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Individuals were eligible if they were:

• at least 18 years old,

• reported injection drug use in the past 30 days,

• met the Diagnostic and Statistical Manual (DSM)-IV criteria for opioid dependence,

• reported using heroin at least 21 out of the past 30 days,

• provided an opiate-positive urine sample,

• showed visible signs of injection drug use (i.e., track marks),

• reported not receiving substance abuse treatment in the past 30 days,

• lived in Baltimore,

• and were unemployed.

Participants were excluded if they

• had current severe psychiatric disorders or chronic medical conditions that would interfere with their ability to participate in the workplace,

• reported current suicidal or homicidal ideation,

• had physical limitations that would prevent them from using a keyboard,

• had medical insurance coverage (as this would disqualify them from receiving interim methadone treatment),

• were pregnant or breastfeeding,

• or were currently considered a prisoner.

Eligible participants were invited to participate in a 4-week induction. 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 and were invited to attend the workplace for an additional 26 weeks

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Learning and Health, Johns Hopkins Bayview Medical Campus, 5200 Eastern Ave., Suite W142	Baltimore	Maryland	United States	21224

Sponsors and Collaborators

• Johns Hopkins University
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Kenneth Silverman, Ph.D., Professor, Johns Hopkins University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT01416584
• Other Study ID Numbers: NA_00020746; R01DA023864
• First Posted: Aug 15, 2011
• Last Update Posted: Dec 5, 2017
• Last Verified: Dec 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Opioid-Related Disorders; Methadone

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	Usual Care Control	Methadone Contingency Group	Methadone & Abstinence Contingency
Arm/Group Description	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.	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.	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.
Period Title: Overall Study
STARTED	30	35	33
COMPLETED	27	33	32
NOT COMPLETED	3	2	1

Baseline Characteristics

Arm/Group Title	Usual Care Control	Methadone Contingency Group	Methadone & Abstinence Contingency	Total
Arm/Group Description	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.	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.	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 of all reporting groups
Overall Participants	30	35	33	98
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	30 100%	34 97.1%	33 100%	97 99%
>=65 years	0 0%	1 2.9%	0 0%	1 1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44 (9)	42 (10)	44 (9)	44 (9)
Sex: Female, Male (Count of Participants)
Female	10 33.3%	8 22.9%	15 45.5%	33 33.7%
Male	20 66.7%	27 77.1%	18 54.5%	65 66.3%
Region of Enrollment (participants) [Number]
United States	30 100%	35 100%	33 100%	98 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Months in Methadone Treatment
Description	The percentage of months in which participants were enrolled in methadone treatment during the 6-month intervention evaluation period?
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Intent to treat

Arm/Group Title	Usual Care Control	Methadone Contingency Group	Methadone & Abstinence Contingency
Arm/Group Description	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.	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.	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.
Measure Participants	30	35	33
Mean (Full Range) [percent of months in methadone treatment]	81	82	88

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Control, Methadone Contingency Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.60
	Comments
	Method	General Estimating Equation (GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.40
	Confidence Interval	(2-Sided) 95%; 0.40 to 4.83
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Usual Care Control, Methadone & Abstinence Contingency
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.88
	Comments
	Method	General Estimating Equation (GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.10
	Confidence Interval	(2-Sided) 95%; 0.32 to 3.73
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Methadone Contingency Group, Methadone & Abstinence Contingency
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.64
	Comments
	Method	General Estimating Equation (GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.27
	Confidence Interval	(2-Sided) 95%; 0.36 to 4.46
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Percentage of Monthly Urine Sample Negative for Opiates
Description	Percentage of urine sample negative for opiates at each of the six 30-day assessments scheduled throughout the intervention evaluation
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Intent to treat

Arm/Group Title	Usual Care Control	Methadone Contingency Group	Methadone & Abstinence Contingency
Arm/Group Description	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.	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.	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.
Measure Participants	30	35	33
Mean (Full Range) [percentage of opiate negative]	54	61	75

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Control, Methadone & Abstinence Contingency
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	General Estimating Equation (GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.39
	Confidence Interval	(2-Sided) 95%; 0.38 to 0.41
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Usual Care Control, Methadone Contingency Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.39
	Comments
	Method	General Estimating Equation (GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 95%; 0.34 to 1.57
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Methadone Contingency Group, Methadone & Abstinence Contingency
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.10
	Comments
	Method	General Estimating Equation (GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.86
	Confidence Interval	(2-Sided) 95%; 1.53 to 2.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Percentage of Monthly Urine Samples Negative for Cocaine
Description	Was the participant's urine sample negative for cocaine at each of the six 30-day assessments scheduled throughout the intervention evaluation period?
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

intent to treat

Arm/Group Title	Usual Care Control	Methadone Contingency Group	Methadone & Abstinence Contingency
Arm/Group Description	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.	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.	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.
Measure Participants	30	35	33
Mean (Full Range) [percentage of cocaine negative]	32	55	57

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Control, Methadone & Abstinence Contingency
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	General Estimating Equation (GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.37
	Confidence Interval	(2-Sided) 95%; 0.36 to 0.38
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Usual Care Control, Methadone Contingency Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	General Estimating Equation (GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.39
	Confidence Interval	(2-Sided) 95%; 0.38 to 0.41
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Methadone Contingency Group, Methadone & Abstinence Contingency
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.85
	Comments
	Method	General Estimating Equation (GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95%; 0.20 to 5.66
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Percentage of M,W,F Urine Samples Negative for Cocaine
Description	Was each participant's urine sample negative for cocaine at each of the Monday, Wednesday, Friday urine samples scheduled throughout the intervention evaluation period?
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

intent to treat

Arm/Group Title	Usual Care Control	Methadone Contingency Group	Methadone & Abstinence Contingency
Arm/Group Description	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.	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.	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.
Measure Participants	30	35	33
Mean (Full Range) [percentage of urine samples]	25	44	48

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Control, Methadone & Abstinence Contingency
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	General Estimating Equation (GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.35
	Confidence Interval	(2-Sided) 95%; 0.34 to 0.35
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Usual Care Control, Methadone Contingency Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	General Estimating Equation (GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.41
	Confidence Interval	(2-Sided) 95%; 0.39 to 0.44
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Methadone Contingency Group, Methadone & Abstinence Contingency
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.63
	Comments
	Method	General Estimating Equation (GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.84
	Confidence Interval	(2-Sided) 95%; 0.42 to 1.69
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Percentage of M,W,F Urine Samples Negative for Opiates
Description	Was each participant's urine sample negative for opiates at each of the Monday, Wednesday, Friday urine samples scheduled throughout the intervention evaluation period?
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

intent to treat

Arm/Group Title	Usual Care Control	Methadone Contingency Group	Methadone & Abstinence Contingency
Arm/Group Description	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.	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.	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.
Measure Participants	30	35	33
Mean (Full Range) [percentage of M,W,F urine samples]	43	50	65

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Control, Methadone & Abstinence Contingency
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	General Estimating Equation (GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.40
	Confidence Interval	(2-Sided) 95%; 0.39 to 0.40
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Usual Care Control, Methadone Contingency Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.37
	Comments
	Method	General Estimating Equation (GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.75
	Confidence Interval	(2-Sided) 95%; 0.36 to 1.55
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Methadone Contingency Group, Methadone & Abstinence Contingency
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	General Estimating Equation (GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.53
	Confidence Interval	(2-Sided) 95%; 0.28 to 1.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Other Pre-specified Outcome

Title	Did Participant Share Needles or Works?
Description	Percent of months that participants reported sharing needles or works.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Due to the very low rate of reports of sharing needles or works in all groups, we did not analyze this measure. This grant has ended and there is no funding to conduct more analyses.

Arm/Group Title	Usual Care Control	Methadone Contingency Group	Methadone & Abstinence Contingency
Arm/Group Description	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.	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.	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.
Measure Participants	0	0	0

7. Other Pre-specified Outcome

Title	Went to Shooting Gallery/House or Other Place Where Users go to Shoot-up?
Description	The percent of months that participants reported going to a shooting gallery/hour or other place where users go to shoot-up.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Due to the very low rate of reports of going to a shooting gallery/house or other place where users go to shoot-up in all groups, we did not analyze this measure. This grant has ended and there is no funding to conduct more analyses.

Arm/Group Title	Usual Care Control	Methadone Contingency Group	Methadone & Abstinence Contingency
Arm/Group Description	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.	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.	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.
Measure Participants	0	0	0

8. Other Pre-specified Outcome

Title	Did Participant Inject Drugs?
Description	Percent of months that participants reported injecting drugs.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

We did not analyze this measure. This grant has ended and there is no funding to conduct more analyses.

Arm/Group Title	Usual Care Control	Methadone Contingency Group	Methadone & Abstinence Contingency
Arm/Group Description	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.	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.	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.
Measure Participants	0	0	0

9. Other Pre-specified Outcome

Title	In Methadone Treatment at End of Treatment
Description	Was each participant in methadone treatment at the end of the 6-month intervention evaluation period?
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

We did not analyze this measure. This grant has ended and there is no funding to conduct more analyses.

Arm/Group Title	Usual Care Control	Methadone Contingency Group	Methadone & Abstinence Contingency
Arm/Group Description	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.	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.	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.
Measure Participants	0	0	0

10. Other Pre-specified Outcome

Title	Entered Methadone Treatment
Description	Did the participant enter methadone treatment at any point in the 6-month treatment period?
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

We did not analyze this measure. This grant has ended and there is no funding to conduct more analyses.

Arm/Group Title	Usual Care Control	Methadone Contingency Group	Methadone & Abstinence Contingency
Arm/Group Description	Participants could work and earn stipends, but did not have to enter methadone treatment or provide drug-free urine samples to work or earn money.	Participants were required to stay enrolled in methadone treatment to work and earn wages.	Participants were required to stay enrolled in methadone treatment to work and earn wages and provide urine samples negative for opiates and cocaine to maintain maximum pay.
Measure Participants	0	0	0

Adverse Events

Time Frame	7 months
Arm/Group Title	Usual Care Control		Methadone Contingency Group		Methadone & Abstinence Contingency
Arm/Group Description	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.		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.		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.
All Cause Mortality
	Usual Care Control		Methadone Contingency Group		Methadone & Abstinence Contingency
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Usual Care Control		Methadone Contingency Group		Methadone & Abstinence Contingency
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/30 (3.3%)		0/35 (0%)		1/33 (3%)
General disorders
Hospitalization for car accident	1/30 (3.3%)	1	0/35 (0%)	0	0/33 (0%)	0
Reproductive system and breast disorders
Hospitalization for Vaginal Swelling	0/30 (0%)	0	0/35 (0%)	0	1/33 (3%)	1
Other (Not Including Serious) Adverse Events
	Usual Care Control		Methadone Contingency Group		Methadone & Abstinence Contingency
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		1/35 (2.9%)		0/33 (0%)
General disorders
Dizziness	0/30 (0%)	0	1/35 (2.9%)	1	0/33 (0%)	0
Inpatient heroin detoxification	0/30 (0%)	0	1/35 (2.9%)	1	0/33 (0%)	0

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.