Trial Outcomes & Findings for Employment-based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction. - 1 (NCT NCT00249496)
NCT ID: NCT00249496
Last Updated: 2017-09-18
Results Overview
The percentage of urine samples collected at monthly assessments that are negative for cocaine.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
1 year
Results posted on
2017-09-18
Participant Flow
Participants (N=128) were enrolled in Phase 1 of the therapeutic workplace. Participants (N=51) who became abstinent and skilled were randomly assigned to an Abstinence \& Employment (Contingency Management), or an Employment Only group.
Participant milestones
| Measure |
Employment Only
Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.
Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.
|
Contingency Management
Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.
Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
27
|
|
Overall Study
COMPLETED
|
24
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Employment-based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction. - 1
Baseline characteristics by cohort
| Measure |
Employment Only
n=24 Participants
Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.
Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.
|
Contingency Management
n=27 Participants
Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.
Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.
|
Total
n=51 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
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 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
|
42.5 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
43.2 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
42.9 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
27 participants
n=7 Participants
|
51 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearThe percentage of urine samples collected at monthly assessments that are negative for cocaine.
Outcome measures
| Measure |
Employment Only
n=24 Participants
Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.
Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.
|
Contingency Management
n=26 Participants
Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.
Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.
|
|---|---|---|
|
Percentage of Monthly Urine Samples That Are Negative for Cocaine
|
51.8 percentage of urine samples
Interval 0.0 to 100.0
|
79.3 percentage of urine samples
Interval 8.0 to 100.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: This measure was not analyzed due to limited funding to confirm the accuracy/completeness of the Mon, Wed, Fri urine data
(The number of Monday, Wednesday and Friday urine samples negative for cocaine/total number of urine samples) x 100. We have not confirmed the accuracy/completeness of the Mon, Wed, Fri urine data at this point. In addition, the monthly data had less missing data than the Monday, Wednesday and Friday data and were sufficient to show the main results of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: intent to treat
(The number of monthly urine samples negative for opiates/total number of urine samples) x 100
Outcome measures
| Measure |
Employment Only
n=24 Participants
Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.
Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.
|
Contingency Management
n=27 Participants
Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.
Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.
|
|---|---|---|
|
Percentage of 30-day Assessment Urine Samples Negative for Opiates
|
90.6 percentage of opiate negative
Interval 25.0 to 100.0
|
88.6 percentage of opiate negative
Interval 8.0 to 100.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: This measure was not analyzed due to limited funding to confirm the accuracy/completeness of the Mon, Wed, Fri urine data.
(The number of Monday, Wednesday and Friday urine samples negative for opiates/total number of urine samples) x 100. We have not confirmed the accuracy/completeness of the Mon, Wed, Fri urine data at this point. In addition, the monthly data had less missing data than the Monday, Wednesday and Friday data and were sufficient to show the main results of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: intent to treat
Percentage of people reporting that they traded sex for drugs or money
Outcome measures
| Measure |
Employment Only
n=24 Participants
Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.
Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.
|
Contingency Management
n=27 Participants
Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.
Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.
|
|---|---|---|
|
HIV Risk Behaviors
|
16.7 percentage of participants
Interval 0.0 to 100.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
Adverse Events
Employment Only
Serious events: 10 serious events
Other events: 17 other events
Deaths: 0 deaths
Contingency Management
Serious events: 10 serious events
Other events: 19 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Employment Only
n=24 participants at risk
Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.
Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.
|
Contingency Management
n=27 participants at risk
Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.
Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.
|
|---|---|---|
|
Gastrointestinal disorders
Hospitalization for abdominal pain
|
0.00%
0/24 • 18 months
|
3.7%
1/27 • Number of events 2 • 18 months
|
|
Psychiatric disorders
Hospitalization for anxiety
|
4.2%
1/24 • Number of events 1 • 18 months
|
0.00%
0/27 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Hospitalization for back pain
|
0.00%
0/24 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
|
Injury, poisoning and procedural complications
Hospitalization for car accident
|
8.3%
2/24 • Number of events 2 • 18 months
|
0.00%
0/27 • 18 months
|
|
Cardiac disorders
Hospitalization for chest pain
|
0.00%
0/24 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
|
Cardiac disorders
Hospitalization for congestive heart failure
|
0.00%
0/24 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
|
Psychiatric disorders
Hospitalization for depression
|
4.2%
1/24 • Number of events 1 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
|
Injury, poisoning and procedural complications
Hospitalization for food poisoning
|
4.2%
1/24 • Number of events 1 • 18 months
|
0.00%
0/27 • 18 months
|
|
Vascular disorders
Hospitalization for high blood sugar
|
4.2%
1/24 • Number of events 1 • 18 months
|
0.00%
0/27 • 18 months
|
|
Infections and infestations
Hospitalization for infection
|
0.00%
0/24 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
|
General disorders
Hospitalization for methadone withdrawal
|
0.00%
0/24 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
|
Surgical and medical procedures
Hospitalization for outpatient surgery
|
8.3%
2/24 • Number of events 2 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
|
Nervous system disorders
Hospitalization for pinched nerve
|
4.2%
1/24 • Number of events 1 • 18 months
|
0.00%
0/27 • 18 months
|
|
General disorders
Hospitalization for pneumonia
|
4.2%
1/24 • Number of events 1 • 18 months
|
7.4%
2/27 • Number of events 2 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for shortness of breath
|
0.00%
0/24 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
|
Social circumstances
Incarcerated
|
4.2%
1/24 • Number of events 1 • 18 months
|
0.00%
0/27 • 18 months
|
|
General disorders
Inpatient drug detoxification, self referred
|
0.00%
0/24 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
|
General disorders
Death, cause undetermined
|
0.00%
0/24 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
Other adverse events
| Measure |
Employment Only
n=24 participants at risk
Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.
Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.
|
Contingency Management
n=27 participants at risk
Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.
Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.
|
|---|---|---|
|
Psychiatric disorders
Anxiety attack, not hospitalized
|
0.00%
0/24 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Arm, wrist, and/or hand pain, not hospitalized
|
12.5%
3/24 • Number of events 3 • 18 months
|
7.4%
2/27 • Number of events 2 • 18 months
|
|
Social circumstances
Assault, not hospitalized
|
4.2%
1/24 • Number of events 1 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma attack, not hospitalized
|
4.2%
1/24 • Number of events 1 • 18 months
|
0.00%
0/27 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Back pain, not hospitalized
|
0.00%
0/24 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
|
Psychiatric disorders
Depression, not hospitalized
|
0.00%
0/24 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
E.R. for abdominal pain
|
0.00%
0/24 • 18 months
|
7.4%
2/27 • Number of events 2 • 18 months
|
|
Injury, poisoning and procedural complications
E.R. for animal bite
|
0.00%
0/24 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
E.R. for asthma attack
|
4.2%
1/24 • Number of events 1 • 18 months
|
0.00%
0/27 • 18 months
|
|
Musculoskeletal and connective tissue disorders
E.R. for back pain
|
16.7%
4/24 • Number of events 4 • 18 months
|
0.00%
0/27 • 18 months
|
|
Musculoskeletal and connective tissue disorders
E.R. for broken bone(s)
|
0.00%
0/24 • 18 months
|
7.4%
2/27 • Number of events 2 • 18 months
|
|
Cardiac disorders
E.R. for chest pains
|
4.2%
1/24 • Number of events 1 • 18 months
|
0.00%
0/27 • 18 months
|
|
Psychiatric disorders
E.R. for depression
|
0.00%
0/24 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
E.R. for gastroenteritis
|
4.2%
1/24 • Number of events 1 • 18 months
|
3.7%
1/27 • Number of events 4 • 18 months
|
|
General disorders
E.R. for general medical treatment
|
8.3%
2/24 • Number of events 2 • 18 months
|
11.1%
3/27 • Number of events 3 • 18 months
|
|
General disorders
E.R for head injury
|
0.00%
0/24 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
|
Vascular disorders
E.R. for hypertension
|
0.00%
0/24 • 18 months
|
7.4%
2/27 • Number of events 2 • 18 months
|
|
Infections and infestations
E.R. for infection
|
4.2%
1/24 • Number of events 1 • 18 months
|
7.4%
2/27 • Number of events 2 • 18 months
|
|
General disorders
E.R. for methadone withdrawal
|
4.2%
1/24 • Number of events 1 • 18 months
|
0.00%
0/27 • 18 months
|
|
Pregnancy, puerperium and perinatal conditions
E.R. for miscarriage
|
4.2%
1/24 • Number of events 1 • 18 months
|
0.00%
0/27 • 18 months
|
|
Gastrointestinal disorders
E.R. for nausea
|
4.2%
1/24 • Number of events 2 • 18 months
|
0.00%
0/27 • 18 months
|
|
General disorders
E.R. for pneumonia
|
4.2%
1/24 • Number of events 1 • 18 months
|
0.00%
0/27 • 18 months
|
|
Injury, poisoning and procedural complications
Injury outside of CLH, not hospitalized
|
16.7%
4/24 • Number of events 4 • 18 months
|
14.8%
4/27 • Number of events 5 • 18 months
|
|
Social circumstances
Loss of medical benefits
|
0.00%
0/24 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
|
General disorders
Methadone withdrawal, not hospitalized
|
4.2%
1/24 • Number of events 1 • 18 months
|
0.00%
0/27 • 18 months
|
|
Injury, poisoning and procedural complications
Minor injury at CLH (i.e. scraped knee
|
4.2%
1/24 • Number of events 1 • 18 months
|
7.4%
2/27 • Number of events 3 • 18 months
|
|
Surgical and medical procedures
Outpatient dental surgery
|
0.00%
0/24 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
|
Nervous system disorders
Seizure, not hospitalized
|
4.2%
1/24 • Number of events 1 • 18 months
|
0.00%
0/27 • 18 months
|
|
General disorders
Sick, not hospitalized
|
4.2%
1/24 • Number of events 2 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
|
Psychiatric disorders
Suicidal ideation
|
4.2%
1/24 • Number of events 1 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
|
Social circumstances
Theft
|
0.00%
0/24 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
|
Social circumstances
Threats of physical violence
|
16.7%
4/24 • Number of events 5 • 18 months
|
25.9%
7/27 • Number of events 7 • 18 months
|
|
Metabolism and nutrition disorders
Vomiting
|
0.00%
0/24 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
|
Injury, poisoning and procedural complications
Wrist injury
|
0.00%
0/24 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 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