Evaluating Three Methods for Helping Syringe Exchangers Begin Methadone Maintenance

Johns Hopkins University

Status: Completed

Conditions: Substance Abuse Disorder

Treatments: Behavioral: Low intensity care; Behavioral: Voucher reinforcement

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01142986

2R01DA012347

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 223 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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223 participants in 3 patient groups

Low Threshold Stepped Care (LTSC)

Experimental group

Description:

Subjects in this condition will receive low intensity care during the first 3-months (13 weeks) of study participation, and usual counseling care during the final 3-months (13 weeks) of participation.

Treatment:

Behavioral: Low intensity care

Voucher-Based Stepped Care (VBSC)

Experimental group

Description:

Subjects in this condition will receive usual counseling care during the entire 6 months of study participation. They will receive voucher reinforcement, and will have the opportunity to earn voucher incentives during the first 3-months of care (13 weeks).

Treatment:

Behavioral: Voucher reinforcement

Routine Stepped-Care (RSC)

No Intervention group

Description:

Subjects in this condition will receive usual counseling care during the entire 6-month study (26 weeks).