Alcohol UseNCT00249496
Employment-based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction. - 1
A study testing Contingency management and Employment Only in people with Alcohol Use and Drug Use, run by Johns Hopkins University at 1 site in United States.
Trial summary
This application is a competing continuation of a grant in which we developed and pilot tested a computerized Therapeutic Workplace designed to train and employ adults as data entry operators. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use, Drug Use, Risk Behavior
- What is being tested?
- Contingency management and Employment Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Aug 2007
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Applicants in methadone treatment may be eligible to participate in Phase 1 of the study.
- Applicants will be blind to the full details of the eligibility criteria.
- Unemployed
- Provided a urine sample at intake with a detectable concentration of cocaine metabolite or provided a cocaine positive sample during regular urinalysis testing at a methadone maintenance program
- Met DSM-IV criteria for cocaine dependence
- Were receiving welfare benefits in Baltimore, MD
- Received a score of less than or equal to 80% correct on a reading assessment
Who cannot join
- Being at imminent risk for suicide
- Reported hallucinations
- Being incarcerated or otherwise under constant monitoring
- Earned less than or equal to $200 in unreported taxable income from legal activity in the previous month
- Having physical limitations that prevented typing
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Learning and Health
Baltimore, Maryland, 21224
About this study
Official title: Therapeutic Workplace Maintenance Study
This application is a competing continuation of a grant in which we developed and pilot tested a computerized Therapeutic Workplace designed to train and employ adults as data entry operators. A randomized trial is planned over 5 years to investigate the Therapeutic Workplace business as a maintenance intervention to sustain long-term abstinence and employment. Welfare recipients in methadone treatment, actively using cocaine, and at risk for contracting or spreading HIV infection will participate in an initial Therapeutic Workplace training phase. Participants who become abstinent and skilled will be randomly assigned to an Abstinence \& Employment, or an Employment Only group. Participants in the Abstinence \& Employment 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. Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work. This study will provide a rigorous evaluation of the efficacy of the Therapeutic Workplace business as a long-term treatment of cocaine addiction and unemployment; determine the benefits of requiring daily evidence of abstinence to work; and provide information on the extent to which a Therapeutic Workplace business can become self-sustaining. This research could provide firm scientific foundation for the dissemination of Therapeutic Workplace businesses in the long-term treatment of cocaine addiction and unemployment. The main hypothesis being tested is that cocaine abstinence will be reliably maintained during the yearlong intervention evaluation period only in the group exposed to the explicit abstinence maintenance intervention. We expect that cocaine abstinence in the Abstinence and Employment group will be significantly greater than cocaine abstinence in the Employment Only group.
Read the detailed description
STUDY PARTICIPANTS This study was approved by the Western Institutional Review Board. Participants were recruited in methadone clinics throughout Baltimore. Recruitment began in October 2003, and the study was completed in August 2007. Of the 251 individuals assessed for eligibility, 128 met these criteria and were invited to participate in the study.
SETTING The study was conducted at the Center for Learning and Health, Johns Hopkins School of Medicine, Baltimore, MD. The workplace included a sign-in station, a urinalysis laboratory, and three workrooms. The workrooms contained 47 computer workstations.
PRE-RANDOMIZATION PROCEDURES Intake Assessment At intake, participants signed informed consent and completed an interview. Urine samples were collected and tested for cocaine, opiates, benzodiazepines, methadone, and amphetamines. A questionnaire was administered to assess participants' capacity to operate a keyboard. The Composite International Diagnostic Interview (CIDI), 2nd ed. was administered to assess drug dependence. Other assessment tools included the Addiction Severity Index - Lite (ASI-Lite), the Risk Assessment Battery (RAB), the Wide Range Achievement Test (WRAT-3), and a reading assessment. Participants were paid $30 in vouchers for completing the interview.
Workroom and Urinalysis Procedures Eligible participants were enrolled in phase 1 and could work in the workplace from 10 AM-12 PM and 1 PM-3 PM every weekday for 6 months. During this phase, participants worked on computerized training programs designed to teach them to become data entry operators. On Monday, Wednesday and Friday, participants provided a urine sample under observation. Breath samples were tested for alcohol. Urine samples were tested for opiates and cocaine and participants received graphs showing current and prior drug test results. Participants earned a base pay of $8.00 per hour in vouchers. Additionally, participants could earn approximately $2.00 per hour in vouchers in productivity pay for working on training programs. Earnings accumulated in the participant's account until exchanged for a gift card or other approved goods and services.
Initially, participants could attend the workplace independent of their urinalysis results. This "workplace induction" continued for at least 4 weeks and until the participant worked for at least 5 min on 15 workdays. After workplace induction, participants were required to provide evidence of cocaine abstinence to work and to maintain maximum pay. Specifically, participants gained access to their workrooms if urinary benzoylecgonine concentration was <300 ng/mL or at least 20% lower per day since the last sample submitted. Participants who provided a cocaine-positive urine sample could not work until they provided a new sample that met the criteria. Upon return to work, the rate of base pay was reduced to $1.00 per hour. Base pay was then increased by $1.00 per hour every day that a participant provided a sample that met the criteria and worked at least 5 minutes until reaching $8.00 per hour. Missing samples were treated as positive. After a participant provided cocaine-negative samples for three consecutive weeks, the abstinence contingency was extended to opiates (ie, urinary benzoylecgonine and morphine concentrations of <300 ng/mL, or decreases in benzoylecgonine and morphine concentrations by at least 20% per day since the last sample submitted). After providing cocaine- and opiate-negative samples for three consecutive weeks the contingency was expanded to include alcohol if the participant had provided alcohol positive (≥0.003 ng/L) samples during the opiate and cocaine contingency period. This stepped contingency program is described in detail elsewhere.
The training programs were designed for individuals with no typing skills. The programs were divided into small steps. Participants practiced steps in one-minute intervals until meeting mastery criteria for the step. Participants earned $0.03 per 20 correct characters typed, and lost $0.01 per 2 incorrect characters typed. Additional productivity pay ranging from $0.25 to $2.00 was provided for achieving step mastery. Participants who finished the typing program proceeded to a data entry training program, which included similar productivity pay contingencies. A detailed report of the results of phase 1 is provided elsewhere.
RANDOMIZATION Eligibility for phase 2 was assessed at the end of the fifth month of phase 1. Participants who attended the workplace on at least 50% of possible days and provided urine samples that met the reinforcement criteria on at least 80% of the collection opportunities during the four weeks prior to assessment, and who attained minimal typing proficiency qualified to participate in phase 2. Individuals not meeting criteria at the end of the fifth month who were still attending the workplace at least occasionally were reevaluated in the sixth month. This reevaluation occurred for seven participants, all of whom were admitted to phase 2 of the study. After meeting phase 2 eligibility criteria, participants were randomly assigned to employment only (n = 24) or abstinence-contingent employment (n = 27), and hired as employees of the nonprofit data entry business for one year. One eligible person declined to participate in phase 2 due to fears of losing social security benefits due to employment, and another was assigned to a discontinued study group (see below). The two groups did not differ significantly on any demographic measure assessed at intake. The phase 2 participants' mean age was 43 years, 77% were female, 88% were black, and 98% were living in poverty.
All stratification and randomization procedures were computerized and carried out by a data coordinator who did not have contact with participants. Participants were stratified according to whether 50% or more of the urine samples collected during the first four weeks of the induction period were positive for opiates; whether 75% or more of these samples were positive for cocaine; and whether they achieved an exceptionally high level of tying proficiency. Personnel who conducted monthly assessments were blind to group assignment.
POST-RANDOMIZATION PROCEDURES Phase 2 Assessments An interview was conducted immediately prior to randomization that included drug testing, the ASI-Lite, the RAB, the Vocational Educational Assessment (VEA, for assessing attitudes about work and employment history), and the Treatment Services Review (TSR, for assessing the use of professional services), and questionnaires covering adverse events and workplace satisfaction. These assessments were repeated every 30 days, except for the RAB, which was only conducted during the 6th and 12th months.
Phase 2 Employment Procedures Upon enrollment in phase 2, participants began employment as data entry operators in Hopkins Data Services.40 While employed by Hopkins Data Services, participants could work from 9 AM to 4 PM, with 1 hour for lunch. Participants earned an hourly wage slightly higher than or equal to the legal minimum (originally $5.25 per hour, but increased to $6.15 per hour when the minimum wage in Maryland increased) and pay for productivity. Contingencies for productivity pay were programmed such that participants would earn approximately $4.00 per hour in productivity pay for normative performance. Participants received regular bi-weekly paychecks instead of vouchers. Although prior employees of Hopkins Data Services performed data entry jobs for paying customers,40 given the nature of the control group (ie, no contingencies on drug abstinence), participants in this study performed data entry jobs in which they entered data batches from completed orders.
Study Groups Participants assigned to the abstinence-contingent employment group were required to provide drug negative urine samples to access the workrooms on mandatory collection days . Initially, all Mondays, Wednesdays, and Fridays were mandatory days. If a participant in this group provided a positive sample or failed to provide a sample on a mandatory day, then the participant was denied access to the workplace on that day, and until the participant provided a sample that met the criteria. In addition, participants whose urine sample did not meet the criteria were given a reset in productivity pay from $4.00 per hour to $1.00 per hour. After a reset, a participant's productivity pay increased by $1.00 per hour per day that the participant worked for a minimum of five minutes, until the standard rate of approximately $4.00 per hour was reinstated.
Participants in the abstinence-contingent employment group who provided urine samples that met the criteria on 30 consecutive calendar days were placed on a random mandatory urine testing schedule. Initially, a schedule was established in which an average of one out of every two Mondays, Wednesdays, and Fridays were designated as mandatory collection and testing days. After every 30 days in which all mandatory samples met the abstinence criteria the average was further reduced by one, until an average of one out of every six Mondays, Wednesdays, and Fridays were randomly designated as mandatory days. Participants could call the workplace to inquire whether that day's urine sample collection was mandatory. If a participant provided a positive sample on a mandatory day or missed a mandatory sample then routine mandatory testing was reinstated and the schedule-thinning process repeated from the beginning. Participants were informed of schedule changes by the workplace manager and given a written notice describing the change. Participants received urinalysis feedback graphs similar to phase 1, however, only the results of mandatory tests were displayed on the graph.
Participants assigned to the employment only group were required to provide urine samples, but were permitted to work independent of the results of urinalysis. Rate of pay was also unaffected by the urinalysis results. In order to equate the urinalysis feedback across groups, employment only participants were placed on a thinning schedule of feedback in which the progressive thinning occurred every 30 days, independent of the participant's urinalysis results. Urine samples from participants in both groups were collected for data purposes every Monday, Wednesday, and Friday that a participant attended the workplace, although participants were only given feedback about the urinalysis results on selected days.
- Conditions
- Alcohol Use, Drug Use, Risk Behavior, Sexual Behavior
- Being tested
- Contingency management, Employment Only
- Keywords
- cocaine, opioids, contingency management, sexual risk, HIV
- Medical subject headings
- Alcohol Drinking, Risk-Taking, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency managementBehavioural
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.
Employment OnlyBehavioural
Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.
| Study group | Role | What they receive |
|---|---|---|
| Employment Only | Active comparator | Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work. Receives: Behavioral: Employment Only |
| Contingency Management | Experimental | 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. Receives: Behavioral: Contingency management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Monthly Urine Samples That Are Negative for Cocaine
The percentage of urine samples collected at monthly assessments that are negative for cocaine.
Measured: 1 year
Secondary outcomes (4)
Percentage of Monday, Wednesday and Friday Urine Samples That Are Negative for Cocaine
(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.
Measured: 1 year
Percentage of 30-day Assessment Urine Samples Negative for Opiates
(The number of monthly urine samples negative for opiates/total number of urine samples) x 100
Measured: 1 year
Percentage of Monday, Wednesday and Friday Urine Samples That Are Negative for Opiates
(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.
Measured: 1 year
HIV Risk Behaviors
Percentage of people reporting that they traded sex for drugs or money
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startOct 2003
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol UseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Kenneth Silverman, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249496
- Sponsor's protocol ID
- WIRB 2093
- Other IDs
- R01DA013107
- Status last verified
- Aug 2017
- First submitted
- 3 Nov 2005
- Last updated
- 18 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: The results were published in a peer-reviewed journal.
Publications
DeFulio A, Donlin WD, Wong CJ, Silverman K. Employment-based abstinence reinforcement as a maintenance intervention for the treatment of cocaine dependence: a randomized controlled trial. Addiction. 2009 Sep;104(9):1530-8. doi: 10.1111/j.1360-0443.2009.02657.x.
PubMed 19686522DeFulio A, Silverman K. Employment-based abstinence reinforcement as a maintenance intervention for the treatment of cocaine dependence: post-intervention outcomes. Addiction. 2011 May;106(5):960-7. doi: 10.1111/j.1360-0443.2011.03364.x. Epub 2011 Mar 7.
PubMed 21226886
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Workplace Maintenance Study
- ClinicalTrials.gov ID
- NCT00249496
- Acronym / sponsor ID
- WIRB 2093
- Conditions
- Alcohol Use, Drug Use, Risk Behavior, Sexual Behavior
- Keywords
- cocaine, opioids, contingency management, sexual risk, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2003
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 7 Nov 2005 (estimated)
- Results
- Posted 16 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This application is a competing continuation of a grant in which we developed and pilot tested a computerized Therapeutic Workplace designed to train and employ adults as data entry operators. A randomized trial is planned over 5 years to investigate the Therapeutic Workplace business as a maintenance intervention to sustain long-term abstinence and employment. Welfare recipients in methadone treatment, actively using cocaine, and at risk for contracting or spreading HIV infection will participate in an initial Therapeutic Workplace training phase. Participants who become abstinent and skilled will be randomly assigned to an Abstinence \& Employment, or an Employment Only group. Participants in the Abstinence \& Employment 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. Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work. This study will provide a rigorous evaluation of the efficacy of the Therapeutic Workplace business as a long-term treatment of cocaine addiction and unemployment; determine the benefits of requiring daily evidence of abstinence to work; and provide information on the extent to which a Therapeutic Workplace business can become self-sustaining. This research could provide firm scientific foundation for the dissemination of Therapeutic Workplace businesses in the long-term treatment of cocaine addiction and unemployment. The main hypothesis being tested is that cocaine abstinence will be reliably maintained during the yearlong intervention evaluation period only in the group exposed to the explicit abstinence maintenance intervention. We expect that cocaine abstinence in the Abstinence and Employment group will be significantly greater than cocaine abstinence in the Employment Only group.
Detailed description
STUDY PARTICIPANTS This study was approved by the Western Institutional Review Board. Participants were recruited in methadone clinics throughout Baltimore. Recruitment began in October 2003, and the study was completed in August 2007. Of the 251 individuals assessed for eligibility, 128 met these criteria and were invited to participate in the study.
SETTING The study was conducted at the Center for Learning and Health, Johns Hopkins School of Medicine, Baltimore, MD. The workplace included a sign-in station, a urinalysis laboratory, and three workrooms. The workrooms contained 47 computer workstations.
PRE-RANDOMIZATION PROCEDURES Intake Assessment At intake, participants signed informed consent and completed an interview. Urine samples were collected and tested for cocaine, opiates, benzodiazepines, methadone, and amphetamines. A questionnaire was administered to assess participants' capacity to operate a keyboard. The Composite International Diagnostic Interview (CIDI), 2nd ed. was administered to assess drug dependence. Other assessment tools included the Addiction Severity Index - Lite (ASI-Lite), the Risk Assessment Battery (RAB), the Wide Range Achievement Test (WRAT-3), and a reading assessment. Participants were paid $30 in vouchers for completing the interview.
Workroom and Urinalysis Procedures Eligible participants were enrolled in phase 1 and could work in the workplace from 10 AM-12 PM and 1 PM-3 PM every weekday for 6 months. During this phase, participants worked on computerized training programs designed to teach them to become data entry operators. On Monday, Wednesday and Friday, participants provided a urine sample under observation. Breath samples were tested for alcohol. Urine samples were tested for opiates and cocaine and participants received graphs showing current and prior drug test results. Participants earned a base pay of $8.00 per hour in vouchers. Additionally, participants could earn approximately $2.00 per hour in vouchers in productivity pay for working on training programs. Earnings accumulated in the participant's account until exchanged for a gift card or other approved goods and services.
Initially, participants could attend the workplace independent of their urinalysis results. This "workplace induction" continued for at least 4 weeks and until the participant worked for at least 5 min on 15 workdays. After workplace induction, participants were required to provide evidence of cocaine abstinence to work and to maintain maximum pay. Specifically, participants gained access to their workrooms if urinary benzoylecgonine concentration was <300 ng/mL or at least 20% lower per day since the last sample submitted. Participants who provided a cocaine-positive urine sample could not work until they provided a new sample that met the criteria. Upon return to work, the rate of base pay was reduced to $1.00 per hour. Base pay was then increased by $1.00 per hour every day that a participant provided a sample that met the criteria and worked at least 5 minutes until reaching $8.00 per hour. Missing samples were treated as positive. After a participant provided cocaine-negative samples for three consecutive weeks, the abstinence contingency was extended to opiates (ie, urinary benzoylecgonine and morphine concentrations of <300 ng/mL, or decreases in benzoylecgonine and morphine concentrations by at least 20% per day since the last sample submitted). After providing cocaine- and opiate-negative samples for three consecutive weeks the contingency was expanded to include alcohol if the participant had provided alcohol positive (≥0.003 ng/L) samples during the opiate and cocaine contingency period. This stepped contingency program is described in detail elsewhere.
The training programs were designed for individuals with no typing skills. The programs were divided into small steps. Participants practiced steps in one-minute intervals until meeting mastery criteria for the step. Participants earned $0.03 per 20 correct characters typed, and lost $0.01 per 2 incorrect characters typed. Additional productivity pay ranging from $0.25 to $2.00 was provided for achieving step mastery. Participants who finished the typing program proceeded to a data entry training program, which included similar productivity pay contingencies. A detailed report of the results of phase 1 is provided elsewhere.
RANDOMIZATION Eligibility for phase 2 was assessed at the end of the fifth month of phase 1. Participants who attended the workplace on at least 50% of possible days and provided urine samples that met the reinforcement criteria on at least 80% of the collection opportunities during the four weeks prior to assessment, and who attained minimal typing proficiency qualified to participate in phase 2. Individuals not meeting criteria at the end of the fifth month who were still attending the workplace at least occasionally were reevaluated in the sixth month. This reevaluation occurred for seven participants, all of whom were admitted to phase 2 of the study. After meeting phase 2 eligibility criteria, participants were randomly assigned to employment only (n = 24) or abstinence-contingent employment (n = 27), and hired as employees of the nonprofit data entry business for one year. One eligible person declined to participate in phase 2 due to fears of losing social security benefits due to employment, and another was assigned to a discontinued study group (see below). The two groups did not differ significantly on any demographic measure assessed at intake. The phase 2 participants' mean age was 43 years, 77% were female, 88% were black, and 98% were living in poverty.
All stratification and randomization procedures were computerized and carried out by a data coordinator who did not have contact with participants. Participants were stratified according to whether 50% or more of the urine samples collected during the first four weeks of the induction period were positive for opiates; whether 75% or more of these samples were positive for cocaine; and whether they achieved an exceptionally high level of tying proficiency. Personnel who conducted monthly assessments were blind to group assignment.
POST-RANDOMIZATION PROCEDURES Phase 2 Assessments An interview was conducted immediately prior to randomization that included drug testing, the ASI-Lite, the RAB, the Vocational Educational Assessment (VEA, for assessing attitudes about work and employment history), and the Treatment Services Review (TSR, for assessing the use of professional services), and questionnaires covering adverse events and workplace satisfaction. These assessments were repeated every 30 days, except for the RAB, which was only conducted during the 6th and 12th months.
Phase 2 Employment Procedures Upon enrollment in phase 2, participants began employment as data entry operators in Hopkins Data Services.40 While employed by Hopkins Data Services, participants could work from 9 AM to 4 PM, with 1 hour for lunch. Participants earned an hourly wage slightly higher than or equal to the legal minimum (originally $5.25 per hour, but increased to $6.15 per hour when the minimum wage in Maryland increased) and pay for productivity. Contingencies for productivity pay were programmed such that participants would earn approximately $4.00 per hour in productivity pay for normative performance. Participants received regular bi-weekly paychecks instead of vouchers. Although prior employees of Hopkins Data Services performed data entry jobs for paying customers,40 given the nature of the control group (ie, no contingencies on drug abstinence), participants in this study performed data entry jobs in which they entered data batches from completed orders.
Study Groups Participants assigned to the abstinence-contingent employment group were required to provide drug negative urine samples to access the workrooms on mandatory collection days . Initially, all Mondays, Wednesdays, and Fridays were mandatory days. If a participant in this group provided a positive sample or failed to provide a sample on a mandatory day, then the participant was denied access to the workplace on that day, and until the participant provided a sample that met the criteria. In addition, participants whose urine sample did not meet the criteria were given a reset in productivity pay from $4.00 per hour to $1.00 per hour. After a reset, a participant's productivity pay increased by $1.00 per hour per day that the participant worked for a minimum of five minutes, until the standard rate of approximately $4.00 per hour was reinstated.
Participants in the abstinence-contingent employment group who provided urine samples that met the criteria on 30 consecutive calendar days were placed on a random mandatory urine testing schedule. Initially, a schedule was established in which an average of one out of every two Mondays, Wednesdays, and Fridays were designated as mandatory collection and testing days. After every 30 days in which all mandatory samples met the abstinence criteria the average was further reduced by one, until an average of one out of every six Mondays, Wednesdays, and Fridays were randomly designated as mandatory days. Participants could call the workplace to inquire whether that day's urine sample collection was mandatory. If a participant provided a positive sample on a mandatory day or missed a mandatory sample then routine mandatory testing was reinstated and the schedule-thinning process repeated from the beginning. Participants were informed of schedule changes by the workplace manager and given a written notice describing the change. Participants received urinalysis feedback graphs similar to phase 1, however, only the results of mandatory tests were displayed on the graph.
Participants assigned to the employment only group were required to provide urine samples, but were permitted to work independent of the results of urinalysis. Rate of pay was also unaffected by the urinalysis results. In order to equate the urinalysis feedback across groups, employment only participants were placed on a thinning schedule of feedback in which the progressive thinning occurred every 30 days, independent of the participant's urinalysis results. Urine samples from participants in both groups were collected for data purposes every Monday, Wednesday, and Friday that a participant attended the workplace, although participants were only given feedback about the urinalysis results on selected days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Employment Only | Active comparator | Behavioral: Employment OnlyEmployment 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 | Experimental | Behavioral: Contingency managementParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Applicants in methadone treatment may be eligible to participate in Phase 1 of the study.
- Applicants will be blind to the full details of the eligibility criteria.
- Unemployed
- Provided a urine sample at intake with a detectable concentration of cocaine metabolite or provided a cocaine positive sample during regular urinalysis testing at a methadone maintenance program
- Met DSM-IV criteria for cocaine dependence
Key exclusion criteria (5 listed)
- Being at imminent risk for suicide
- Reported hallucinations
- Being incarcerated or otherwise under constant monitoring
- Earned less than or equal to $200 in unreported taxable income from legal activity in the previous month
- Having physical limitations that prevented typing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contingency managementParticipants 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. | Behavioural | Contingency Management |
| Employment OnlyEmployment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work. | Behavioural | Employment Only |
Primary outcome
Percentage of Monthly Urine Samples That Are Negative for Cocaine
Time frame: 1 year
The percentage of urine samples collected at monthly assessments that are negative for cocaine.
4 secondary outcomes
Percentage of Monday, Wednesday and Friday Urine Samples That Are Negative for Cocaine
Time frame: 1 year
Percentage of 30-day Assessment Urine Samples Negative for Opiates
Time frame: 1 year
Percentage of Monday, Wednesday and Friday Urine Samples That Are Negative for Opiates
Time frame: 1 year
HIV Risk Behaviors
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19686522DeFulio A, Donlin WD, Wong CJ, Silverman K. Employment-based abstinence reinforcement as a maintenance intervention for the treatment of cocaine dependence: a randomized controlled trial. Addiction. 2009 Sep;104(9):1530-8. doi: 10.1111/j.1360-0443.2009.02657.x.
- Derived from this study: PubMed 21226886DeFulio A, Silverman K. Employment-based abstinence reinforcement as a maintenance intervention for the treatment of cocaine dependence: post-intervention outcomes. Addiction. 2011 May;106(5):960-7. doi: 10.1111/j.1360-0443.2011.03364.x. Epub 2011 Mar 7.
- Individual participant dataSharing planned: No. The results were published in a peer-reviewed journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Silverman, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency management and Employment Only in people with Alcohol Use and Drug Use, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Monthly Urine Samples That Are Negative for Cocaine (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00249496, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2017.