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The Therapeutic Workplace Initiation Study

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ClinicalTrials.gov Identifier: NCT00249470
Recruitment Status : Completed
First Posted : November 7, 2005
Results First Posted : December 16, 2016
Last Update Posted : December 27, 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
Opioid-Related Disorders
Heroin Dependence
Substance Abuse, Intravenous
Interventions Behavioral: Abstinence & Work
Behavioral: Work Only
Enrollment 117
Recruitment Details  
Pre-assignment Details 56 completed the induction period and were randomly assigned to the two study groups.
Arm/Group Title Abstinence & Work Work Only
Hide Arm/Group Description

Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.

Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.

Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.

Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.

Period Title: Overall Study
Started 28 28
Completed 28 28
Not Completed 0 0
Arm/Group Title Abstinence & Work Work Only Total
Hide Arm/Group Description

Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.

Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.

Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.

Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.

Total of all reporting groups
Overall Number of Baseline Participants 28 28 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 28 participants 56 participants
43.9  (6.5) 47.5  (5.8) 45.7  (6.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 56 participants
Female
17
  60.7%
17
  60.7%
34
  60.7%
Male
11
  39.3%
11
  39.3%
22
  39.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 28 participants 56 participants
28 28 56
1.Primary Outcome
Title Cocaine Abstinence
Hide Description Percentage of Monday, Wednesday, Friday urine samples that are negative for cocaine
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Abstinence & Work Work Only
Hide Arm/Group Description:

Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.

Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.

Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.

Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.

Overall Number of Participants Analyzed 28 28
Mean (Full Range)
Unit of Measure: percentage of cocaine negative
29
(0 to 99)
10
(0 to 64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abstinence & Work, Work Only
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .004
Comments [Not Specified]
Method General Estimating Equation (GEE)
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.80
Confidence Interval (2-Sided) 95%
2.03 to 16.56
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent Opiate Negative
Hide Description (total number of opiate-negative urine samples divided by the total number of urine samples provided)*100
Time Frame every month for 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
intent to treat
Arm/Group Title Abstinence & Work Work Only
Hide Arm/Group Description:

Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.

Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.

Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.

Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.

Overall Number of Participants Analyzed 28 28
Mean (Full Range)
Unit of Measure: percentage of opiate negative
55.4
(0 to 100)
62.5
(0 to 100)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abstinence & Work, Work Only
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%
0.40 to 2.08
Estimation Comments [Not Specified]
3.Secondary Outcome
Title HIV Risk Behaviors
Hide Description Report no injection drug use or crack cocaine use.
Time Frame every month for 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The data represent the mean percentage of participants that reported no injection drug use or crack cocaine use. Missing assessments were considered positive (i.e., injection drug or crack cocaine use).
Arm/Group Title Abstinence & Work Work Only
Hide Arm/Group Description:

Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.

Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.

Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.

Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.

Overall Number of Participants Analyzed 28 28
Mean (Full Range)
Unit of Measure: percentage of participants
28.0
(0 to 78)
16.1
(0 to 67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abstinence & Work, Work Only
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method General Estimating Equation (GEE)
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.37
Confidence Interval (2-Sided) 95%
1.21 to 9.37
Estimation Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Abstinence & Work Work Only
Hide Arm/Group Description

Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.

Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.

Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.

Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.

All-Cause Mortality
Abstinence & Work Work Only
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Abstinence & Work Work Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/28 (14.29%)      2/28 (7.14%)    
Cardiac disorders     
Death from heart attack  [1]  1/28 (3.57%)  1 0/28 (0.00%)  0
Hospitalization for congestive heart failure  [2]  1/28 (3.57%)  1 0/28 (0.00%)  0
Gastrointestinal disorders     
Hospitalization for abdominal pain  [2]  1/28 (3.57%)  1 0/28 (0.00%)  0
General disorders     
Hospitalization for general medical treatment  [2]  1/28 (3.57%)  1 1/28 (3.57%)  1
Hospitalization for inpatient surgery  [2]  1/28 (3.57%)  1 0/28 (0.00%)  0
Infections and infestations     
Hospitalization for infection  [2]  0/28 (0.00%)  0 1/28 (3.57%)  1
Indicates events were collected by systematic assessment
[1]
Death occurred about 5 months after leaving the study.
[2]
Not related
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Abstinence & Work Work Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/28 (0.00%)      0/28 (0.00%)    
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: Dr. Kenneth Silverman
Organization: Johns Hopkins School of Medicine: Department of Psychiatry
Phone: 410-550-2694
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00249470     History of Changes
Other Study ID Numbers: WIRB 2162
R01DA012564 ( U.S. NIH Grant/Contract )
First Submitted: November 3, 2005
First Posted: November 7, 2005
Results First Submitted: September 2, 2016
Results First Posted: December 16, 2016
Last Update Posted: December 27, 2017