Trial Outcomes & Findings for Employment-Based Depot Naltrexone Clinical Trial II (NCT NCT00684775)
NCT ID: NCT00684775
Last Updated: 2018-01-23
Results Overview
The percentage of depot naltrexone doses that participants received
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
24 weeks
Results posted on
2018-01-23
Participant Flow
Participant milestones
| Measure |
Work Plus Naltrexone Prescription
Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the "Work Plus Naltrexone Prescription" condition could work and earn salary independent of whether or not they took depot naltrexone injections.
|
Work Plus Naltrexone Contingency
Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone for 6 months. "Work Plus Naltrexone Contingency" participants were required to take monthly depot naltrexone injections to work and earn salary.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Employment-Based Depot Naltrexone Clinical Trial II
Baseline characteristics by cohort
| Measure |
1 Work Plus Naltrexone Prescription
n=19 Participants
Work Plus Naltrexone Prescription
employment-based reinforcement: Vivitrol, an extended-release depot formulation of naltrexone, will be used. Participants will be offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) 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. Participants in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone injections 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.
|
2 Work Plus Naltrexone Contingency
n=19 Participants
Work Plus Naltrexone Contingency
employment-based reinforcement: Vivitrol, an extended-release depot formulation of naltrexone, will be used. Participants will be offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) 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. Participants in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone injections 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.
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Total
n=38 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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42 years
STANDARD_DEVIATION 10 • n=99 Participants
|
45 years
STANDARD_DEVIATION 8 • n=107 Participants
|
44 years
STANDARD_DEVIATION 9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
16 participants
n=99 Participants
|
18 participants
n=107 Participants
|
34 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
3 participants
n=99 Participants
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1 participants
n=107 Participants
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4 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: intent-to-treat
The percentage of depot naltrexone doses that participants received
Outcome measures
| Measure |
Work Plus Naltrexone Prescription
n=19 Participants
Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone injections for 6 months. Participants in the "Work Plus Naltrexone Prescription" condition could work and earn wages independent of whether or not the took scheduled injections.
|
Work Plus Naltrexone Contingency
n=19 Participants
Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone for 6 months. Participants in the "Work Plus Naltrexone Contingency" condition earned access to working and earning salary by taking depot naltrexone injections once per month.
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|---|---|---|
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Naltrexone Injections Received
|
51.8 Percentage of injections received
Interval 0.0 to 100.0
|
86.8 Percentage of injections received
Interval 33.0 to 100.0
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PRIMARY outcome
Timeframe: 24 weeksThe time to the first missed dose of depot naltrexone
Outcome measures
| Measure |
Work Plus Naltrexone Prescription
n=19 Participants
Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone injections for 6 months. Participants in the "Work Plus Naltrexone Prescription" condition could work and earn wages independent of whether or not the took scheduled injections.
|
Work Plus Naltrexone Contingency
n=19 Participants
Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone for 6 months. Participants in the "Work Plus Naltrexone Contingency" condition earned access to working and earning salary by taking depot naltrexone injections once per month.
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|---|---|---|
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Time to the First Missed Dose
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14.74 weeks
Standard Deviation 7.67
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20.84 weeks
Standard Deviation 5.59
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SECONDARY outcome
Timeframe: Collected every 30 days for 150 daysPopulation: intent to treat
Percentage of urine samples collected at the 30-day assessments that are negative for opiates
Outcome measures
| Measure |
Work Plus Naltrexone Prescription
n=19 Participants
Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone injections for 6 months. Participants in the "Work Plus Naltrexone Prescription" condition could work and earn wages independent of whether or not the took scheduled injections.
|
Work Plus Naltrexone Contingency
n=19 Participants
Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone for 6 months. Participants in the "Work Plus Naltrexone Contingency" condition earned access to working and earning salary by taking depot naltrexone injections once per month.
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|---|---|---|
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Percentage of 30-day Urine Samples Negative for Opiates
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65.3 percentage of opiate negative
Interval 0.0 to 100.0
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71.6 percentage of opiate negative
Interval 0.0 to 100.0
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SECONDARY outcome
Timeframe: Collected every Monday, Wednesday and Friday for 24 weeksPopulation: intent to treat
Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for cocaine
Outcome measures
| Measure |
Work Plus Naltrexone Prescription
n=19 Participants
Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone injections for 6 months. Participants in the "Work Plus Naltrexone Prescription" condition could work and earn wages independent of whether or not the took scheduled injections.
|
Work Plus Naltrexone Contingency
n=19 Participants
Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone for 6 months. Participants in the "Work Plus Naltrexone Contingency" condition earned access to working and earning salary by taking depot naltrexone injections once per month.
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|---|---|---|
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Percentage of M-W-F Samples Negative for Cocaine
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45.3 percentage of mwf cocaine negative
Interval 0.0 to 97.0
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54.6 percentage of mwf cocaine negative
Interval 1.0 to 100.0
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SECONDARY outcome
Timeframe: Collected every 30 days for 150 daysPopulation: intent to treat
The percentage of urine samples collected at 30-day assessments that are negative for cocaine.
Outcome measures
| Measure |
Work Plus Naltrexone Prescription
n=19 Participants
Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone injections for 6 months. Participants in the "Work Plus Naltrexone Prescription" condition could work and earn wages independent of whether or not the took scheduled injections.
|
Work Plus Naltrexone Contingency
n=19 Participants
Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone for 6 months. Participants in the "Work Plus Naltrexone Contingency" condition earned access to working and earning salary by taking depot naltrexone injections once per month.
|
|---|---|---|
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Average Percentage of 30-day Urine Samples Negative for Cocaine
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53.7 percentage cocaine negative urine sample
Interval 0.0 to 100.0
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57.9 percentage cocaine negative urine sample
Interval 0.0 to 100.0
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SECONDARY outcome
Timeframe: 24 weeksbehaviors that place participants at risk for acquiring or transmitting HIV infection
Outcome measures
| Measure |
Work Plus Naltrexone Prescription
n=19 Participants
Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone injections for 6 months. Participants in the "Work Plus Naltrexone Prescription" condition could work and earn wages independent of whether or not the took scheduled injections.
|
Work Plus Naltrexone Contingency
n=19 Participants
Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone for 6 months. Participants in the "Work Plus Naltrexone Contingency" condition earned access to working and earning salary by taking depot naltrexone injections once per month.
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|---|---|---|
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HIV Risk Behaviors
|
2.1 percentage of months reported
Standard Deviation 14.4
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0 percentage of months reported
Standard Deviation 0
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SECONDARY outcome
Timeframe: Collected every Monday, Wednesday and Friday for 24 weeksPopulation: intent to treatment
Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for opiates
Outcome measures
| Measure |
Work Plus Naltrexone Prescription
n=19 Participants
Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone injections for 6 months. Participants in the "Work Plus Naltrexone Prescription" condition could work and earn wages independent of whether or not the took scheduled injections.
|
Work Plus Naltrexone Contingency
n=19 Participants
Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone for 6 months. Participants in the "Work Plus Naltrexone Contingency" condition earned access to working and earning salary by taking depot naltrexone injections once per month.
|
|---|---|---|
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Percentage of M,W,F Urine Samples Negative for Opiates
|
51.8 percentage of opiate negative
Interval 4.0 to 99.0
|
66.2 percentage of opiate negative
Interval 7.0 to 100.0
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Adverse Events
1 Work Plus Naltrexone Prescription
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
2 Work Plus Naltrexone Contingency
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1 Work Plus Naltrexone Prescription
n=19 participants at risk
Work Plus Naltrexone Prescription
employment-based reinforcement: Vivitrol, an extended-release depot formulation of naltrexone, will be used. Participants will be offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) 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. Participants in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone injections 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.
|
2 Work Plus Naltrexone Contingency
n=19 participants at risk
Work Plus Naltrexone Contingency
employment-based reinforcement: Vivitrol, an extended-release depot formulation of naltrexone, will be used. Participants will be offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) 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. Participants in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone injections 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.
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|---|---|---|
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Skin and subcutaneous tissue disorders
Injection site reaction
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5.3%
1/19 • Number of events 1 • Every month for 6 months
|
21.1%
4/19 • Number of events 4 • Every month for 6 months
|
|
Reproductive system and breast disorders
Reduced sex drive
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0.00%
0/19 • Every month for 6 months
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5.3%
1/19 • Number of events 1 • Every month for 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
1/19 • Number of events 1 • Every month for 6 months
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0.00%
0/19 • Every month for 6 months
|
|
General disorders
Sleeplessness
|
0.00%
0/19 • Every month for 6 months
|
5.3%
1/19 • Number of events 1 • Every month for 6 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/19 • Every month for 6 months
|
5.3%
1/19 • Number of events 1 • Every month for 6 months
|
Additional Information
Dr. Kenneth Silverman
Johns 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