Trial Outcomes & Findings for Employment-based Reinforcement of Naltrexone Ingestion and Abstinence (NCT NCT00149669)
NCT ID: NCT00149669
Last Updated: 2017-09-14
Results Overview
The number of urine samples positive for naltrexone divided by the total number of urine samples times 100.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
6 months
Results posted on
2017-09-14
Participant Flow
Participant milestones
| Measure |
Work Plus Naltrexone Prescription
Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
|
Work Plus Naltrexone Contingency
Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
35
|
|
Overall Study
COMPLETED
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Employment-based Reinforcement of Naltrexone Ingestion and Abstinence
Baseline characteristics by cohort
| Measure |
Work Plus Naltrexone Prescription
n=32 Participants
Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
|
Work Plus Naltrexone Contingency
n=35 Participants
Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
|
Total
n=67 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
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 7 • n=5 Participants
|
43 years
STANDARD_DEVIATION 9 • n=7 Participants
|
45 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
35 participants
n=7 Participants
|
67 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: intent to treat
The number of urine samples positive for naltrexone divided by the total number of urine samples times 100.
Outcome measures
| Measure |
Work Plus Naltrexone Prescription
n=32 Participants
Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
|
Work Plus Naltrexone Contingency
n=35 Participants
Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
|
|---|---|---|
|
Percentage of Urine Samples Positive for Naltrexone
|
21 Percentage of Urine Samples
Interval 0.0 to 100.0
|
72 Percentage of Urine Samples
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: intent to treat
the number of urine samples that were negative for cocaine divided by the total number of urine samples) x 100
Outcome measures
| Measure |
Work Plus Naltrexone Prescription
n=32 Participants
Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
|
Work Plus Naltrexone Contingency
n=35 Participants
Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
|
|---|---|---|
|
Percentage of Urine Samples Negative for Cocaine
|
53 Percentage of Urine Samples
Interval 0.0 to 100.0
|
56 Percentage of Urine Samples
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: intent to treat
The number of urine samples negative for opiates divided by the total number of urine samples times 100.
Outcome measures
| Measure |
Work Plus Naltrexone Prescription
n=32 Participants
Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
|
Work Plus Naltrexone Contingency
n=35 Participants
Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
|
|---|---|---|
|
Percentage of Urine Samples Negative for Opiates
|
60 Percentage of Urine Samples
Interval 0.0 to 100.0
|
71 Percentage of Urine Samples
Interval 0.0 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: These data were not analyzed due to limited funding. Funding this project has ended and we have no money to continue any summary or analyses.
Behaviors that place participants at risk for acquiring or transmitting HIV
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: These data were not analyzed due to limited funding. Funding this project has ended and we have no money to continue any summary or analyses.
The costs and economic benefits of the intervention
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: These data were not analyzed due to limited funding. Funding this project has ended and we have no money to continue any summary or analyses.
The percentage of urine and breath samples that are negative for other drugs of abuse
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: These data were not analyzed due to limited funding. Funding this project has ended and we have no money to continue any summary or analyses.
The number of urine samples that were positive for cocaine
Outcome measures
Outcome data not reported
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: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Work Plus Naltrexone Prescription
n=32 participants at risk
Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
|
Work Plus Naltrexone Contingency
n=35 participants at risk
Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
|
|---|---|---|
|
General disorders
death by narcotic intoxication
|
0.00%
0/32
|
2.9%
1/35 • Number of events 1
|
Other adverse events
| Measure |
Work Plus Naltrexone Prescription
n=32 participants at risk
Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
|
Work Plus Naltrexone Contingency
n=35 participants at risk
Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
|
|---|---|---|
|
Reproductive system and breast disorders
Ejaculation difficulty
|
3.1%
1/32 • Number of events 1
|
5.7%
2/35 • Number of events 3
|
|
General disorders
General medical treatment,
|
3.1%
1/32 • Number of events 1
|
0.00%
0/35
|
|
General disorders
Inpatient heroin detoxification
|
3.1%
1/32 • Number of events 1
|
0.00%
0/35
|
|
General disorders
Jitters or shakes
|
3.1%
1/32 • Number of events 1
|
0.00%
0/35
|
|
Hepatobiliary disorders
Abnormal Liver Function Test
|
0.00%
0/32
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal cramps
|
0.00%
0/32
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting, diarrhea, chills
|
0.00%
0/32
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
E.R. for nausea
|
0.00%
0/32
|
2.9%
1/35 • Number of events 1
|
|
Cardiac disorders
Rapid heart rate
|
0.00%
0/32
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
E.R. for adnominal pain
|
0.00%
0/32
|
2.9%
1/35 • Number of events 1
|
|
General disorders
headache
|
0.00%
0/32
|
2.9%
1/35 • Number of events 2
|
|
General disorders
Insomnia
|
0.00%
0/32
|
2.9%
1/35 • Number of events 1
|
|
General disorders
Withdrawal
|
0.00%
0/32
|
2.9%
1/35 • Number of events 1
|
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