Clinical trial NCT01142986: Evaluating Three Methods for Helping Syringe Exchangers Begin Methadone Maintenance
Official title: Evaluating Three Methods for Helping Syringe Exchangers Begin Methadone Maintenance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse Disorder
Keywords: Methadone
Syringe exchange
Treatment retention
Voucher incentives
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-06-14
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Treatment retention and time to dropout
timeFrame: Weekly for 26 weeks
measure: Substance use
timeFrame: Weekly for 26 weeks
measure: Infectious disease risk behaviors
timeFrame: Monthly for 6 months
Secondary outcomes:
measure: Other problem severity
timeFrame: Monthly for 6 months
measure: Counseling engagement
timeFrame: Weekly for 26 weeks
measure: Methadone dose
timeFrame: Weekly for 26 weeks
measure: Treatment readiness
timeFrame: Monthly for 6 months
measure: Treatment satisfaction
timeFrame: Monthly for 6 months
measure: Use of syringe exchange and other community-based services
timeFrame: Monthly for 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Addiction Treatment Services
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Michael Kidorf, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: