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Employment-based Reinforcement of Naltrexone Ingestion and Abstinence

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ClinicalTrials.gov Identifier: NCT00149669
Recruitment Status : Completed
First Posted : September 8, 2005
Results First Posted : August 16, 2017
Last Update Posted : September 14, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cocaine-Related Disorders
Heroin Dependence
Opioid-Related Disorders
Substance Abuse, Intravenous
Intervention Behavioral: employment-based reinforcement
Enrollment 67

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Work Plus Naltrexone Prescription Work Plus Naltrexone Contingency
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 32 35
Completed 29 30
Not Completed 3 5
Arm/Group Title Work Plus Naltrexone Prescription Work Plus Naltrexone Contingency Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 32 35 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 35 participants 67 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
32
 100.0%
35
 100.0%
67
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 35 participants 67 participants
47  (7) 43  (9) 45  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 35 participants 67 participants
Female
10
  31.3%
16
  45.7%
26
  38.8%
Male
22
  68.8%
19
  54.3%
41
  61.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants 35 participants 67 participants
32 35 67
1.Primary Outcome
Title Percentage of Urine Samples Positive for Naltrexone
Hide Description The number of urine samples positive for naltrexone divided by the total number of urine samples times 100.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
intent to treat
Arm/Group Title Work Plus Naltrexone Prescription Work Plus Naltrexone Contingency
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 32 35
Mean (Full Range)
Unit of Measure: Percentage of Urine Samples
21
(0 to 100)
72
(0 to 100)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Work Plus Naltrexone Prescription, Work Plus Naltrexone Contingency
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method General Estimating Equation (GEE)
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 8.67
Confidence Interval (2-Sided) 95%
4.24 to 17.73
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Urine Samples Negative for Cocaine
Hide Description the number of urine samples that were negative for cocaine divided by the total number of urine samples) x 100
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
intent to treat
Arm/Group Title Work Plus Naltrexone Prescription Work Plus Naltrexone Contingency
Hide Arm/Group Description:
Participants were prescribed naltrexone, but were not be required to ingest it to work. Participants could work and earn money, independent of whether or not they continued to take naltrexone.
Participants were required to ingest naltrexone to work, and received a brief pay decrease for missing a dose (employment-based reinforcement of naltrexone ingestion).
Overall Number of Participants Analyzed 32 35
Mean (Full Range)
Unit of Measure: Percentage of Urine Samples
53
(0 to 100)
56
(0 to 100)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Work Plus Naltrexone Prescription, Work Plus Naltrexone Contingency
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments [Not Specified]
Method General Estimating Equation (GEE)
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
.43 to 1.95
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Urine Samples Negative for Opiates
Hide Description The number of urine samples negative for opiates divided by the total number of urine samples times 100.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
intent to treat
Arm/Group Title Work Plus Naltrexone Prescription Work Plus Naltrexone Contingency
Hide Arm/Group Description:
Participants were prescribed naltrexone, but were not be required to ingest it to work. Participants could work and earn money, independent of whether or not they continued to take naltrexone.
Participants were required to ingest naltrexone to work, and received a brief pay decrease for missing a dose (employment-based reinforcement of naltrexone ingestion).
Overall Number of Participants Analyzed 32 35
Mean (Full Range)
Unit of Measure: Percentage of Urine Samples
60
(0 to 100)
71
(0 to 100)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Work Plus Naltrexone Prescription, Work Plus Naltrexone Contingency
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.19
Comments [Not Specified]
Method General Estimating Equation (GEE)
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.61
Confidence Interval (2-Sided) 95%
0.29 to 1.26
Estimation Comments [Not Specified]
4.Other Pre-specified Outcome
Title HIV Risk Behaviors
Hide Description Behaviors that place participants at risk for acquiring or transmitting HIV
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Work Plus Naltrexone Prescription Work Plus Naltrexone Contingency
Hide Arm/Group Description:
Participants were prescribed naltrexone, but were not be required to ingest it to work. Participants could work and earn money, independent of whether or not they continued to take naltrexone.
Participants were required to ingest naltrexone to work, and received a brief pay decrease for missing a dose (employment-based reinforcement of naltrexone ingestion).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Other Pre-specified Outcome
Title Cost Benefit Analysis
Hide Description The costs and economic benefits of the intervention
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Work Plus Naltrexone Prescription Work Plus Naltrexone Contingency
Hide Arm/Group Description:
Participants were prescribed naltrexone, but were not be required to ingest it to work. Participants could work and earn money, independent of whether or not they continued to take naltrexone.
Participants were required to ingest naltrexone to work, and received a brief pay decrease for missing a dose (employment-based reinforcement of naltrexone ingestion).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Other Pre-specified Outcome
Title Percentage of Urine/Breath Samples Negative for Other Drugs of Abuse
Hide Description The percentage of urine and breath samples that are negative for other drugs of abuse
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Work Plus Naltrexone Prescription Work Plus Naltrexone Contingency
Hide Arm/Group Description:
Participants were prescribed naltrexone, but were not be required to ingest it to work. Participants could work and earn money, independent of whether or not they continued to take naltrexone.
Participants were required to ingest naltrexone to work, and received a brief pay decrease for missing a dose (employment-based reinforcement of naltrexone ingestion).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Other Pre-specified Outcome
Title Cocaine Positive Urine Samples
Hide Description The number of urine samples that were positive for cocaine
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Work Plus Naltrexone Prescription Work Plus Naltrexone Contingency
Hide Arm/Group Description:
Participants were prescribed naltrexone, but were not be required to ingest it to work. Participants could work and earn money, independent of whether or not they continued to take naltrexone.
Participants were required to ingest naltrexone to work, and received a brief pay decrease for missing a dose (employment-based reinforcement of naltrexone ingestion).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Work Plus Naltrexone Prescription Work Plus Naltrexone Contingency
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Work Plus Naltrexone Prescription Work Plus Naltrexone Contingency
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Work Plus Naltrexone Prescription Work Plus Naltrexone Contingency
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/32 (0.00%)      1/35 (2.86%)    
General disorders     
death by narcotic intoxication   0/32 (0.00%)  0 1/35 (2.86%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Work Plus Naltrexone Prescription Work Plus Naltrexone Contingency
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/32 (12.50%)      7/35 (20.00%)    
Cardiac disorders     
Rapid heart rate   0/32 (0.00%)  0 1/35 (2.86%)  1
Gastrointestinal disorders     
Abdominal cramps   0/32 (0.00%)  0 1/35 (2.86%)  1
Vomiting, diarrhea, chills   0/32 (0.00%)  0 1/35 (2.86%)  1
E.R. for nausea   0/32 (0.00%)  0 1/35 (2.86%)  1
E.R. for adnominal pain   0/32 (0.00%)  0 1/35 (2.86%)  1
General disorders     
General medical treatment,   1/32 (3.13%)  1 0/35 (0.00%)  0
Inpatient heroin detoxification   1/32 (3.13%)  1 0/35 (0.00%)  0
Jitters or shakes   1/32 (3.13%)  1 0/35 (0.00%)  0
headache   0/32 (0.00%)  0 1/35 (2.86%)  2
Insomnia   0/32 (0.00%)  0 1/35 (2.86%)  1
Withdrawal   0/32 (0.00%)  0 1/35 (2.86%)  1
Hepatobiliary disorders     
Abnormal Liver Function Test   0/32 (0.00%)  0 1/35 (2.86%)  1
Reproductive system and breast disorders     
Ejaculation difficulty   1/32 (3.13%)  1 2/35 (5.71%)  3
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Name/Title: Kenneth Silverman
Organization: Johns Hopkins University School of Medicine
Phone: 410-550-2694
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00149669     History of Changes
Other Study ID Numbers: NA_00039284
R01DA019386 ( U.S. NIH Grant/Contract )
NA_00039284 ( Other Identifier: Johns Hopkins Medicine IRB )
First Submitted: September 6, 2005
First Posted: September 8, 2005
Results First Submitted: September 2, 2016
Results First Posted: August 16, 2017
Last Update Posted: September 14, 2017