The Therapeutic Workplace Initiation Study

Methods Setting and Materials This study was conducted at the Center for Learning and Health,
a treatment-research unit at the Johns Hopkins Bayview Medical Center, Baltimore, MD. The
therapeutic workplace included a workplace sign-in station and urinalysis laboratory, and
three workrooms (and associated staff space) where training occurred. When participants
arrived at the workplace each day, they reported to the workplace sign-in station located at
the entrance to the urinalysis laboratory. Staff sat on the laboratory side of the entrance
at the workplace sign-in station desk, which was equipped with a Dell personal computer and
electronic barcode reader (Unitech® Barcode Slot Reader model # MS140I-2, St Louis, MO).

Urine and breath samples were collected and tested in the urinalysis laboratory. Breath
samples were tested for alcohol with the AlcoSensor III (Intoximeter, St. Louis, MO). Females
provided urine samples directly into Commode Specimen Containers (Catalog #00077, Sage
Products, Inc., Crystal Lake, IL) that were placed directly on the toilet. The urine samples
were then temperature tested and transferred to storage cups. Males provided samples directly
into paper cups, which were then temperature tested and transferred to storage cups. All
urine samples were temperature tested using an F-1500 Electronic Thermometer (Sherwood
Medical, St. Louis, MO). The urinalysis laboratory contained an Abbott AxSYM® immunoassay
system for urine testing. The AxSYM® employs fluorescent polarization immunoassay (FPIA)
technology (Abbott Laboratories, Abbott Park, IL).

Participants received the therapeutic workplace training programs in three workrooms (a total
of 161 m2) that contained a total of 47 individual three-sided workstations (155 cm tall x 64
cm deep x 126 cm wide). Each workstation was equipped with a desktop (60 cm deep x 121 cm
wide); a height adjustable chair with arms; a Dell personal computer, keyboard and mouse.
Keyboards were covered with removable plastic covers (Protect Keyboard Cover, West Bountiful,
UT) that were painted black that so that the letters on the keys could not be read while
typing. Each participant was given a water bottle, headphones for listening to music CDs
during training on the personal computer, a cooler for storing lunch, and picture frames to
personalize the workstation.

The three workrooms opened into a central area (31 m2) where the workroom assistants sat to
monitor the activities of participants in the workrooms. Participants had to pass through the
central staff area to enter and leave the workrooms. The central area was equipped with three
desks, each with a personal computer. Each desk also was equipped with a Unitech® electronic
barcode slot reader.

All of the participant and staff computers were interconnected through a high-speed (T1) line
to central Dell PowerEdge servers. All of the typing, keypad and data entry training
programs; monitoring of the work time and earnings; and the voucher system were controlled by
a custom web-based therapeutic workplace software application program that resided on one of
the PowerEdge servers (Silverman et al., 2005).

Recruitment and Participant Selection The Western Institutional Review Board approved this
study. Participants were enrolled in this study from April 2003 to November 2003. To recruit
participants, flyers and letters were distributed to 11 Baltimore City methadone programs
inviting unemployed adults in methadone treatment to apply to enroll in a study that provided
job skills training and monetary vouchers. Research staff also visited the methadone
treatment programs to describe the study to methadone treatment staff (e.g., counselors).

Interested individuals who approached or called research staff first completed an anonymous
brief screening interview in which they were asked 8 questions designed to determine quickly
if they might be eligible for the study. Some of the questions were added to conceal the
eligibility requirements. The interview asked the individuals' age, marital status,
employment status, drugs and routes of administration used in the past 30 days, what type of
drug abuse treatment they currently receive, whether they receive welfare benefits, how much
they earned through employment in the past 30 days, and whether they have any of several
medical conditions (e.g., asthma, HIV). Brief screening interviews were conducted over the
phone, in person at the methadone treatment programs, or in person at the Center for Learning
and Health. Applicants were invited to participate in a full screening interview if they
reported that they were 18 years or older, were unemployed, injected heroin or cocaine, used
cocaine or crack in the past 30 days, and if they were currently enrolled in methadone
maintenance treatment in Baltimore City.

Full screening interview. At the beginning of the full screening interview, participants were
invited to sign the initial screening consent form. Participants were required to pass a
written quiz about the details of the consent form to participate. Participants were also
required to read a paragraph of the consent form aloud and to read at least 80% of the words
correctly to continue in the full screening interview.

Baseline period. Eligible participants were invited to attend the workplace for 4 hours every
weekday for 8 weeks. Mandatory urine samples were collected prior to work every Monday,
Wednesday and Friday. All samples were tested for cocaine and opiates. During the first 4
weeks, participants could attend the workplace independent of their urinalysis results and
earn a base pay of $8.00 per hour plus pay for performance on training programs. To encourage
brief breaks, participants could earn 5 minutes of paid break for every 55 minutes worked.
Pay was earned in vouchers exchangeable for goods and services. At the end of baseline,
participants who attended the workplace at least 50% of the workdays, provided at least two
cocaine-positive urine samples, and were still enrolled in methadone treatment were invited
to participate in the main randomized controlled portion of the study. Other participants
could continue to work for 4 additional weeks, but were required to provide urine samples
that indicated recent abstinence from opiates and cocaine to work.

Experimental Design and Groups Stratification and random assignment. Participants enrolled in
the main study (N = 56) were randomly assigned to the Work Only (n = 28) or Abstinence & Work
(n = 28) group. Immediately prior to actual assignment, a study coordinator, who did not have
direct contact with participants, randomized participants using a computer program and a
stratification procedure (similar to Silverman et al., 2004) based on a) whether 75% or more
of the participant's baseline urine samples tested positive for cocaine (Y/N), and b) whether
100% of the participant's baseline urine samples tested positive for cocaine (Y/N).

Study groups. Both groups were invited to attend the workplace throughout a 26-week
intervention period. Participants in both groups continued to provide mandatory urine samples
and could earn base and performance pay. Both groups also received the same feedback as to
the results of the urinalysis testing. The two groups differed only in that participants in
the Abstinence & Work group were required to provide urine samples that indicated recent
cocaine abstinence (i.e., decreased urinary benzoylecgonine concentration of 20% per day from
the last sample provided or benzoylecgonine concentration at or below 300 ng/mL; adapted from
procedures developed by Preston, Schuster, Silverman & Cone, 1997) to gain access to the
workplace and to maintain the maximum base pay of $8.00 per hour. If the participant ever
provided a urine sample that did not meet the criteria for recent cocaine abstinence or if
the participant failed to provide a scheduled sample, the participant was not allowed to work
that day and the participant's base pay was decreased to $1.00 per hour. In addition, the
participant was required to provide a urine sample every workday until the participant
provided a sample that met the abstinence requirement. After a participant's base pay was
reset, it increased by $1.00 per hour to a maximum of $8.00 per hour for every day that the
participant met the cocaine abstinence requirement and worked at least 5 minutes. The voucher
system and the schedule of escalating reinforcement for sustained abstinence and workplace
attendance was adapted from a system developed by Higgins et al., 1991.

General Workplace Procedures Urine collection, testing and feedback. After signing into the
workplace on mandatory urine days (typically Monday, Wednesday and Friday of each week),
participants were required to provide a urine and breath sample under observation by a
same-gender research staff member. Urine collection was performed using well-developed and
elaborate urine-collection procedures designed to ensure the collection of valid urine
samples. Urine samples were tested for cocaine and opiates.

For participants who had to provide evidence of recent cocaine abstinence to enter the
workroom, immediately after the participant provided the urine sample, the sample was tested
and the results (i.e., the quantitative value in ng/mL for benzoylecgonine and the
dichotomous result of negative or positive for opiates) were entered into the therapeutic
workplace software. The software automatically determined whether or not the sample met the
cocaine abstinence criterion for that day, displayed a message reporting the result of that
determination, and printed a feedback graph to be given to the participant. The feedback
graph showed on a log scale the benzoylecgonine concentrations of all samples provided by the
participant over consecutive calendar days, along with a line indicating the criterion for
cocaine abstinence for each of the days. In addition, a text box was printed to the side of
the graph that indicated the results for the current day including the benzoylecgonine
concentration, whether the sample tested negative or positive for opiates, and if the
participant was granted access to the workplace. If the sample met the cocaine abstinence
requirement, the sign-in station assistant gave the participant his or her bar-coded picture
ID card to bring to the workroom assistant to gain entrance to the participant's workroom.

During conditions in which there were no contingencies on cocaine abstinence to gain access
to the workplace (i.e., during the baseline period and during the intervention period for the
Work Only participants), immediately after a participant provided a urine sample and before
the sample was tested, the sign-in station assistant handed the participant his or her
bar-coded picture ID card to bring to the workroom assistant to gain entrance to the
participant's workroom. Later that day, the participant's sample was tested, the results were
entered into the therapeutic workplace software, and a feedback graph (identical to the one
described above) was printed and delivered to the participant.

Baseline inclusion criteria:

- are at least 18 years of age

- are enrolled in methadone maintenance treatment in Baltimore

- provide a cocaine-positive urine sample at time of initial screening

- self-report cocaine use through intravenous route

- have visible evidence of intravenous drug use (i.e., track marks).

Baseline exclusion criteria:

- report current suicidal ideation

- if the individual reports hallucinations

- have physical limitations (e.g., broken fingers) that prevent the subject from typing.

- Applicants reporting hallucinations are excluded because this is a characteristic of a
psychiatric disorder that is likely to result in behaviors that could disrupt the
workplace or functioning or limit their ability to provide informed consent.

Main study inclusion criteria:

- have attended the workplace regularly during 4-week baseline periods

- are still in methadone maintenance treatment at the end of the 4-week baseline period

- have provided at least two urine samples that test positive for cocaine during the
baseline period

- Individuals who are excluded from the main study will be allowed to complete their
8-week training program in the Therapeutic Workplace. They may also be invited to
participate in other studies ongoing at the Center for Learning and Health where this
research takes place.