Employment-Based Depot Naltrexone Clinical Trial

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00684788
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 35
• Location: 1
• Arms: 2
• Actual Duration (Months): 36.1
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether employment-based naltrexone treatment proves effective in promoting depot naltrexone adherence and drug abstinence.

Condition or Disease	Intervention/Treatment	Phase
Opiate Dependence	Combination Product: employment-based reinforcement	Phase 2

Detailed Description

A randomized study is planned over 5 years to evaluate the effectiveness of the Therapeutic Workplace in promoting naltrexone adherence in opiate-dependent adults. An extended-release depot formulation of naltrexone will be used. Participants will be offered an inpatient opioid detoxification and naltrexone induction. Participants who complete the oral naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Patients in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone once per month. "Work Plus Naltrexone Prescription" participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so.

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Employment-Based Depot Naltrexone Clinical Trial
• Actual Study Start Date: May 1, 2006
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 3, 2009

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: No Intervention Participants were offered depot naltrexone injections and were not required to take scheduled injections to work.
Experimental: Employment-based reinforcement Participants were offered depot naltrexone injections and were required to take scheduled injections to work.	Combination Product: employment-based reinforcement; Participants in the "Work Plus Naltrexone Contingency" condition were required to take scheduled doses of depot naltrexone to work and earn wages.

Outcome Measures

Primary Outcome Measures

1. Percentage of Depot Naltrexone Doses Received [18 Weeks]

   The number of depot naltrexone injections received/divided by the total number of injections possible for each participant.

Secondary Outcome Measures

1. The Time to the First Missed Dose of Depot Naltrexone [18 weeks]

   The number of weeks until the first missed dose of depot naltrexone

2. Percentage of 30-day Assessments Urine Samples Negative for Opiates [4 months]

   (The number of urine samples that were negative for opiates/total number of urine samples)x 100

3. Percentage of Monday, Wednesday, Friday Urine Samples Negative for Opiates [18 weeks]

   Total number of opiate-negative urine samples divided by the total number of possible urine samples X 100

4. Percentage of 30-day Assessments Urine Samples Negative for Cocaine [4 months]

   (The number of urine samples that were negative for cocaine/total number of urine samples)x 100

5. Percentage of Monday, Wednesday, Friday Urine Samples Negative for Cocaine [18 weeks]

   Total number of cocaine-negative urine samples divided by the total number of possible urine samples X 100

6. HIV Risk Behaviors [4 months]

   Went to a crack house

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:

• met the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition (DSM-IV) criteria for opioid dependence,

• reported using heroin on at least 21 of the last 30 days while in community,

• were unemployed,

• were aged 18-65 years,

• were medically approved for naltrexone

• lived in or near Baltimore, MD.

Individuals were excluded if they

• had current DSM-IV major Axis I disorders,

• had current suicidal or homicidal ideation,

• expressed interest in methadone treatment,

• were required to use opioids for medical purposes,

• earned more than $200 in taxable income over the previous 30 days,

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

• were pregnant or breastfeeding,

• had serum aminotransferase levels more than three times over normal.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Center for Learning and Health	Baltimore	Maryland	United States	21224

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Kenneth Silverman, Ph.D., Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT00684788
• Other Study ID Numbers: NA_00000928-1; R01DA019497
• First Posted: May 28, 2008
• Last Update Posted: Dec 26, 2017
• Last Verified: Nov 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Johns Hopkins University: opiate dependence; naltrexone; reinforcement; behavior therapy; cocaine dependence; risk reduction behavior
• Additional relevant MeSH terms: Opioid-Related Disorders

Study Results

Participant Flow

Recruitment Details	Volunteers were recruited from detoxification programs in Baltimore, MD and through street outreach between October, 2006 and April, 2008.
Pre-assignment Detail	Participants were required to complete opioid detoxification and were invited to attend the therapeutic workplace for induction onto oral naltrexone. During induction, participants were required to take scheduled oral naltrexone doses to gain access to the therapeutic workplace. Induction continued until three consecutive doses were ingested.

Arm/Group Title	Work Plus Naltrexone Prescription	Work Plus Naltrexone Contingency
Arm/Group Description	Participants who completed the oral naltrexone induction were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. "Work Plus Naltrexone Prescription" participants were encouraged to take depot naltrexone for 6 months, but access to working and earning salary will not be contingent on doing so.	Participants who completed the oral naltrexone induction were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone injections for 6 months.
Period Title: Overall Study
STARTED	17	18
COMPLETED	17	18
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Work Plus Naltrexone Prescription	Work Plus Naltrexone Contingency	Total
Arm/Group Description	An extended-release depot formulation of naltrexone was used. Participants were offered an inpatient opioid detoxification and an oral naltrexone induction. Participants who complete the oral naltrexone induction (N=35) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. "Work Plus Naltrexone Prescription" participants were encouraged to take depot naltrexone for 6 months, but access to working and earning salary will not be contingent on doing so.	An extended-release depot formulation of naltrexone was used. Participants were offered an inpatient opioid detoxification and an oral naltrexone induction. Participants who complete the oral naltrexone induction (N=35) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the "Work Plus Naltrexone Contingency" condition earned access to working and earning salary by taking depot naltrexone injections for 6 months.	Total of all reporting groups
Overall Participants	17	18	35
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42 (6)	43 (7)	42 (6)
Sex: Female, Male (Count of Participants)
Female	8 47.1%	8 44.4%	16 45.7%
Male	9 52.9%	10 55.6%	19 54.3%
Region of Enrollment (participants) [Number]
United States	17 100%	18 100%	35 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Depot Naltrexone Doses Received
Description	The number of depot naltrexone injections received/divided by the total number of injections possible for each participant.
Time Frame	18 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Work Plus Naltrexone Prescription	Work Plus Naltrexone Contingency
Arm/Group Description	An extended-release depot formulation of naltrexone was used. Participants will be offered an inpatient opioid detoxification and an oral naltrexone induction. Participants who completed the oral naltrexone induction (N=35) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the "Work Plus Naltrexone Contingency" condition earned access to working and earning salary by taking depot naltrexone injections for 6 months. "Work Plus Naltrexone Prescription" participants were encouraged to take depot naltrexone for 6 months, but access to working and earning salary will not be contingent on doing so.	Participants will be offered an inpatient opioid detoxification and an oral naltrexone induction. Participants who completed the oral naltrexone induction (N=35) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the "Work Plus Naltrexone Contingency" condition earned access to working and earning salary by taking depot naltrexone injections for 6 months. "Work Plus Naltrexone Prescription" participants were encouraged to take depot naltrexone for 6 months, but access to working and earning salary will not be contingent on doing so.
Measure Participants	17	18
Mean (Full Range) [percentage of injections]	42.2	80.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Work Plus Naltrexone Prescription, Work Plus Naltrexone Contingency
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	=0.008
	Comments
	Method	General Estimating Equation (GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	5.68
	Confidence Interval	(2-Sided) 95%; 1.61 to 20.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	The Time to the First Missed Dose of Depot Naltrexone
Description	The number of weeks until the first missed dose of depot naltrexone
Time Frame	18 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Work Plus Naltrexone Prescription	Work Plus Naltrexone Contingency
Arm/Group Description	Participants were offered depot naltrexone injections and were not required to take scheduled injections to work.	Participants were offered depot naltrexone injections and were required to take scheduled injections to work.
Measure Participants	17	18
Mean (Standard Deviation) [weeks]	9.3 (6.8)	15.5 (4.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Work Plus Naltrexone Prescription, Work Plus Naltrexone Contingency
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0033
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Percentage of 30-day Assessments Urine Samples Negative for Opiates
Description	(The number of urine samples that were negative for opiates/total number of urine samples)x 100
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Work Plus Naltrexone Prescription	Work Plus Naltrexone Contingency
Arm/Group Description	"Work Plus Naltrexone Prescription" participants were encouraged to take depot naltrexone, but access to working and earning salary will not be contingent on doing so.	Participants in the "Work Plus Naltrexone Contingency" condition earned access to working and earning salary by taking depot naltrexone injections.
Measure Participants	17	18
Mean (Full Range) [percentage of opiate negative]	61.8	73.6

4. Secondary Outcome

Title	Percentage of Monday, Wednesday, Friday Urine Samples Negative for Opiates
Description	Total number of opiate-negative urine samples divided by the total number of possible urine samples X 100
Time Frame	18 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Work Plus Naltrexone Prescription	Work Plus Naltrexone Contingency
Arm/Group Description	Participants who completed the oral naltrexone induction were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. "Work Plus Naltrexone Prescription" participants were encouraged to take depot naltrexone for 6 months, but access to working and earning salary will not be contingent on doing so.	Participants who completed the oral naltrexone induction were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone injections for 6 months.
Measure Participants	17	18
Mean (Full Range) [percentage of opiate negative]	51.6	72.0

5. Secondary Outcome

Title	Percentage of 30-day Assessments Urine Samples Negative for Cocaine
Description	(The number of urine samples that were negative for cocaine/total number of urine samples)x 100
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Work Plus Naltrexone Prescription	Work Plus Naltrexone Contingency
Arm/Group Description	Participants who completed the oral naltrexone induction were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. "Work Plus Naltrexone Prescription" participants were encouraged to take depot naltrexone for 6 months, but access to working and earning salary will not be contingent on doing so.	Participants who completed the oral naltrexone induction were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone injections for 6 months.
Measure Participants	17	18
Mean (Full Range) [percentage of cocaine negative]	54.4	55.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Work Plus Naltrexone Prescription, Work Plus Naltrexone Contingency
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.939
	Comments
	Method	General Estimating Equation (GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95%; 0.32 to 3.42
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Percentage of Monday, Wednesday, Friday Urine Samples Negative for Cocaine
Description	Total number of cocaine-negative urine samples divided by the total number of possible urine samples X 100
Time Frame	18 weeks

Outcome Measure Data

Analysis Population Description

intent to treat

Arm/Group Title	Work Plus Naltrexone Prescription	Work Plus Naltrexone Contingency
Arm/Group Description	Participants who completed the oral naltrexone induction were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. "Work Plus Naltrexone Prescription" participants were encouraged to take depot naltrexone for 6 months, but access to working and earning salary will not be contingent on doing so.	Participants who completed the oral naltrexone induction were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone injections for 6 months.
Measure Participants	17	18
Mean (Full Range) [percentage of cocaine negative]	48.9	55.6

7. Secondary Outcome

Title	HIV Risk Behaviors
Description	Went to a crack house
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Work Plus Naltrexone Prescription	Work Plus Naltrexone Contingency
Arm/Group Description	Participants who completed the oral naltrexone induction were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. "Work Plus Naltrexone Prescription" participants were encouraged to take depot naltrexone for 6 months, but access to working and earning salary will not be contingent on doing so.	Participants who completed the oral naltrexone induction were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone injections for 6 months.
Measure Participants	17	18
Mean (Standard Deviation) [percentage of months reported]	5 (22)	5 (23)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Work Plus Naltrexone Prescription, Work Plus Naltrexone Contingency
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.959
	Comments
	Method	General Estimating Equation (GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.074
	Confidence Interval	(2-Sided) 95%; 0.071 to 16.245
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	6 months
Arm/Group Title	Work Plus Naltrexone Prescription		Work Plus Naltrexone Contingency
Arm/Group Description	An extended-release depot formulation of naltrexone was used. Participants were offered an inpatient opioid detoxification and an oral naltrexone induction. Participants who completed the oral naltrexone induction (N=35) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the "Work Plus Naltrexone Contingency" condition earned access to working and earning salary by taking depot naltrexone injections for 6 months.		An extended-release depot formulation of naltrexone was used. Participants were offered an inpatient opioid detoxification and an oral naltrexone induction. Participants who completed the oral naltrexone induction (N=35) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the "Work Plus Naltrexone Contingency" condition earned access to working and earning salary by taking depot naltrexone injections for 6 months. "
All Cause Mortality
	Work Plus Naltrexone Prescription		Work Plus Naltrexone Contingency
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/18 (0%)
Serious Adverse Events
	Work Plus Naltrexone Prescription		Work Plus Naltrexone Contingency
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Work Plus Naltrexone Prescription		Work Plus Naltrexone Contingency
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/17 (23.5%)		9/18 (50%)
Gastrointestinal disorders
Nausea	0/17 (0%)	0	2/18 (11.1%)	2
General disorders
Sleeplessness	1/17 (5.9%)	1	1/18 (5.6%)	1
Hepatobiliary disorders
Abnormal Liver Function Test	0/17 (0%)	0	1/18 (5.6%)	1
Reproductive system and breast disorders
Reduced sex drive	1/17 (5.9%)	1	1/18 (5.6%)	1
Skin and subcutaneous tissue disorders
Injection site reaction	3/17 (17.6%)	3	4/18 (22.2%)	7
Rash	0/17 (0%)	0	1/18 (5.6%)	1
Vascular disorders
Headache	0/17 (0%)	0	1/18 (5.6%)	1

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.