Trial Outcomes & Findings for Employment-Based Depot Naltrexone Clinical Trial (NCT NCT00684788)
NCT ID: NCT00684788
Last Updated: 2017-12-26
Results Overview
The number of depot naltrexone injections received/divided by the total number of injections possible for each participant.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
18 Weeks
Results posted on
2017-12-26
Participant Flow
Volunteers were recruited from detoxification programs in Baltimore, MD and through street outreach between October, 2006 and April, 2008.
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.
Participant milestones
| Measure |
Work Plus Naltrexone Prescription
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.
|
Work Plus Naltrexone Contingency
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.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
|
Overall Study
COMPLETED
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Employment-Based Depot Naltrexone Clinical Trial
Baseline characteristics by cohort
| Measure |
Work Plus Naltrexone Prescription
n=17 Participants
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.
|
Work Plus Naltrexone Contingency
n=18 Participants
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
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 6 • n=93 Participants
|
43 years
STANDARD_DEVIATION 7 • n=4 Participants
|
42 years
STANDARD_DEVIATION 6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=93 Participants
|
18 participants
n=4 Participants
|
35 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 18 WeeksThe number of depot naltrexone injections received/divided by the total number of injections possible for each participant.
Outcome measures
| Measure |
Work Plus Naltrexone Prescription
n=17 Participants
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.
|
Work Plus Naltrexone Contingency
n=18 Participants
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.
|
|---|---|---|
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Percentage of Depot Naltrexone Doses Received
|
42.2 percentage of injections
Interval 0.0 to 100.0
|
80.6 percentage of injections
Interval 16.67 to 100.0
|
SECONDARY outcome
Timeframe: 18 weeksThe number of weeks until the first missed dose of depot naltrexone
Outcome measures
| Measure |
Work Plus Naltrexone Prescription
n=17 Participants
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.
|
Work Plus Naltrexone Contingency
n=18 Participants
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.
|
|---|---|---|
|
The Time to the First Missed Dose of Depot Naltrexone
|
9.3 weeks
Standard Deviation 6.8
|
15.5 weeks
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: 4 months(The number of urine samples that were negative for opiates/total number of urine samples)x 100
Outcome measures
| Measure |
Work Plus Naltrexone Prescription
n=17 Participants
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.
|
Work Plus Naltrexone Contingency
n=18 Participants
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.
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|---|---|---|
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Percentage of 30-day Assessments Urine Samples Negative for Opiates
|
61.8 percentage of opiate negative
Interval 0.0 to 100.0
|
73.6 percentage of opiate negative
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: 18 weeksTotal number of opiate-negative urine samples divided by the total number of possible urine samples X 100
Outcome measures
| Measure |
Work Plus Naltrexone Prescription
n=17 Participants
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.
|
Work Plus Naltrexone Contingency
n=18 Participants
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.
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|---|---|---|
|
Percentage of Monday, Wednesday, Friday Urine Samples Negative for Opiates
|
51.6 percentage of opiate negative
Interval 0.0 to 100.0
|
72.0 percentage of opiate negative
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: 4 months(The number of urine samples that were negative for cocaine/total number of urine samples)x 100
Outcome measures
| Measure |
Work Plus Naltrexone Prescription
n=17 Participants
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.
|
Work Plus Naltrexone Contingency
n=18 Participants
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.
|
|---|---|---|
|
Percentage of 30-day Assessments Urine Samples Negative for Cocaine
|
54.4 percentage of cocaine negative
Interval 0.0 to 100.0
|
55.6 percentage of cocaine negative
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: 18 weeksPopulation: intent to treat
Total number of cocaine-negative urine samples divided by the total number of possible urine samples X 100
Outcome measures
| Measure |
Work Plus Naltrexone Prescription
n=17 Participants
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.
|
Work Plus Naltrexone Contingency
n=18 Participants
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.
|
|---|---|---|
|
Percentage of Monday, Wednesday, Friday Urine Samples Negative for Cocaine
|
48.9 percentage of cocaine negative
Interval 0.0 to 100.0
|
55.6 percentage of cocaine negative
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: 4 monthsWent to a crack house
Outcome measures
| Measure |
Work Plus Naltrexone Prescription
n=17 Participants
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.
|
Work Plus Naltrexone Contingency
n=18 Participants
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.
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|---|---|---|
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HIV Risk Behaviors
|
5 percentage of months reported
Standard Deviation 22
|
5 percentage of months reported
Standard Deviation 23
|
Adverse Events
Work Plus Naltrexone Prescription
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Work Plus Naltrexone Contingency
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Work Plus Naltrexone Prescription
n=17 participants at risk
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.
|
Work Plus Naltrexone Contingency
n=18 participants at risk
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. "
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|---|---|---|
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Hepatobiliary disorders
Abnormal Liver Function Test
|
0.00%
0/17 • 6 months
|
5.6%
1/18 • Number of events 1 • 6 months
|
|
Vascular disorders
Headache
|
0.00%
0/17 • 6 months
|
5.6%
1/18 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
17.6%
3/17 • Number of events 3 • 6 months
|
22.2%
4/18 • Number of events 7 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/17 • 6 months
|
11.1%
2/18 • Number of events 2 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/17 • 6 months
|
5.6%
1/18 • Number of events 1 • 6 months
|
|
Reproductive system and breast disorders
Reduced sex drive
|
5.9%
1/17 • Number of events 1 • 6 months
|
5.6%
1/18 • Number of events 1 • 6 months
|
|
General disorders
Sleeplessness
|
5.9%
1/17 • Number of events 1 • 6 months
|
5.6%
1/18 • Number of events 1 • 6 months
|
Additional Information
Dr. Kenneth Silverman
Hopkins School of Medicine: Department of Psychiatry
Phone: 410-550-2694
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place