Evaluating Three Methods for Helping Syringe Exchangers Begin Methadone Maintenance



Status:Completed
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:8/1/2018
Start Date:July 2010
End Date:October 2015

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This research is being done to evaluate the effectiveness of three different treatment
strategies for helping subjects begin and adjust to methadone maintenance treatment at
Addiction Treatment Services (ATS). Subjects will be randomly assigned to one of three
treatment conditions: 1) Voucher-Based Stepped Care (VBSC) induction, 2) Low-threshold
Stepped Care (LTSC) induction, or 3) Routine Stepped Care (RSC) induction. It is hypothesized
that subjects in both the VBSC and LTSC condition will remain in treatment longer than
subjects in the RSC condition. In addition, it is hypothesized that VBSC and LTSC subjects
will have less drug-positive urine samples and will report less infectious disease risk
behaviors than RSC subjects.

This study will evaluate two alternative methods of inducting syringe exchange referrals into
routine methadone treatment. The sample (N=390) will be opioid-dependent injection drug users
referred by the Baltimore Needle Exchange Program (BNEP) for routine outpatient methadone
treatment using a stepped care model. Subjects will be randomly assigned to one of three
3-month treatment induction conditions: 1) Low Threshold Stepped Care induction (LTSC), 2)
Voucher-Based Stepped Care induction (VBSC), or 3) Routine Stepped-Care induction (RSC). The
LTSC condition will noticeably reduce treatment demands on new admissions during the 90-day
induction period and is conceptually related to an interim maintenance schedule. It is
expected to increase patient recognition of the reinforcing effects and benefits of
methadone, improve the transition to more comprehensive schedules of care, and increase early
retention. The VBSC condition adds an attendance reinforcement intervention to the routine
stepped care induction schedule over the first 90-days of treatment. It is expected to
improve early treatment engagement and retention. Subjects in each of these conditions will
transition to routine stepped-care (no voucher-based reinforcement) following the 90-day
induction period. The RSC condition will serve as a comparison group and represents routine
care in the program where the study will be conducted. All subjects will be followed for
6-months. Retention, drug use (via urinalysis and self-report), and other infectious disease
risk behaviors (e.g., syringe sharing; number of injections) are the primary outcome
measures. The proposed design will also test mediational models to evaluate changes in
objective indices of engagement (methadone and counseling adherence) and psychological
constructs (treatment readiness and satisfaction) as predictors of outcome. Regression models
will be used to evaluate the amount of reduction of drug use necessary to effect varying
amounts of change in HIV risk behavior. Finally, data will be collected and compared on the
treatment costs of each induction strategy.

Inclusion Criteria:

- Participation in the Baltimore Needle Exchange Program (BNEP)

- Expressed interest in treatment with methadone.

Exclusion Criteria:

- Pregnancy

- Currently in a treatment program using methadone or other agonist medications

- Failure to meet DSM-IV criteria for opioid physical dependence and CSAT guidelines for
long-term use of opioid agonist medications

- Presence of an acute medical problem that requires immediate and intense medical
management (e.g., AIDS defining illness; tuberculosis; unstable diabetes,
hypertension, and other problems)

- Presence of a formal thought disorder, delusions, hallucinations, or imminent risk of
harm to self or others (symptoms commonly associated with schizophrenia, bipolar
disorder, and other major mental illnesses).
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