Evaluating Three Methods for Helping Syringe Exchangers Begin Methadone Maintenance
Condition: Substance Abuse Disorder
MeSH terms: Substance-Related Disorders
Study type: Interventional

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.
    

Intervention name(s): Low intensity care; Voucher reinforcement
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Methadone; Syringe exchange; Treatment retention; Voucher incentives