Evaluating Three Methods for Helping Syringe Exchangers Begin Methadone Maintenance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

223 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Substance Abuse Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Low Threshold Stepped Care (LTSC)

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.

Group Type EXPERIMENTAL

Low intensity care

Intervention Type BEHAVIORAL

During the first 3-months (13 weeks), subjects will be scheduled to attend one individual counseling session per month. Subjects will not be required to attend any group counseling sessions during this time. After the first 3-months of care, subjects will start usual counseling care, at which time they will be required to attend one individual counseling session per week, and may be required to attend additional individual and group counseling sessions each week for missed sessions or continued use of drugs or alcohol.

Voucher-Based Stepped Care (VBSC)

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).

Group Type EXPERIMENTAL

Voucher reinforcement

Intervention Type BEHAVIORAL

Subjects will receive usual counseling care during the 26 weeks of study participation.They will be required to attend one individual counseling session per week, and will be required to attend additional individual and group sessions each week for missed session or continued use of drugs or alcohol.In addition, subjects in this condition will have the opportunity to earn voucher incentives each week during the first 13 weeks of care.These incentives can be earned by taking daily methadone doses and attending all scheduled counseling sessions (individual and group).The first voucher is worth $12.00, and each voucher after that is worth an additional $13.50. Bonuses of $30.00 will be awarded for each 3 consecutive weeks of compliance.The total amount possible to earn in the study is $1329.00. Each week that the subject is not compliant,they will not earn a voucher and the value of the next voucher will be reset to $12.00.The vouchers can be used for goods and services in the community.

Routine Stepped-Care (RSC)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Low intensity care

During the first 3-months (13 weeks), subjects will be scheduled to attend one individual counseling session per month. Subjects will not be required to attend any group counseling sessions during this time. After the first 3-months of care, subjects will start usual counseling care, at which time they will be required to attend one individual counseling session per week, and may be required to attend additional individual and group counseling sessions each week for missed sessions or continued use of drugs or alcohol.

Intervention Type BEHAVIORAL

Voucher reinforcement

Subjects will receive usual counseling care during the 26 weeks of study participation.They will be required to attend one individual counseling session per week, and will be required to attend additional individual and group sessions each week for missed session or continued use of drugs or alcohol.In addition, subjects in this condition will have the opportunity to earn voucher incentives each week during the first 13 weeks of care.These incentives can be earned by taking daily methadone doses and attending all scheduled counseling sessions (individual and group).The first voucher is worth $12.00, and each voucher after that is worth an additional $13.50. Bonuses of $30.00 will be awarded for each 3 consecutive weeks of compliance.The total amount possible to earn in the study is $1329.00. Each week that the subject is not compliant,they will not earn a voucher and the value of the next voucher will be reset to $12.00.The vouchers can be used for goods and services in the community.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No