Evaluating Three Methods for Helping Syringe Exchangers Begin Methadone Maintenance
|ClinicalTrials.gov Identifier: NCT01142986|
Recruitment Status : Completed
First Posted : June 14, 2010
Last Update Posted : January 16, 2018
|Condition or disease||Intervention/treatment|
|Substance Abuse Disorder||Behavioral: Low intensity care Behavioral: Voucher reinforcement|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||223 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Evaluating Three Methods for Helping Syringe Exchangers Begin Methadone Maintenance|
|Study Start Date :||July 2010|
|Primary Completion Date :||October 2015|
|Study Completion Date :||October 2015|
Experimental: 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.
Behavioral: 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.
Experimental: 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).
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.
No Intervention: Routine Stepped-Care (RSC)
Subjects in this condition will receive usual counseling care during the entire 6-month study (26 weeks).
- Treatment retention and time to dropout [ Time Frame: Weekly for 26 weeks ]The length of time subjects remain in treatment is tracked throughout the study. Retention will be assessed as: 1) percent of subjects remaining in treatment at 3 and 6-months, and 2) time to dropout.
- Substance use [ Time Frame: Weekly for 26 weeks ]Subjects are required to leave weekly urine specimens (for 12-weeks) which are tested for drugs of abuse. Percent positive for opiates, cocaine, benzodiazepines, and cannabis will be evaluated weekly. Self-report use will be assessed for subjects in and out of treatment.
- Infectious disease risk behaviors [ Time Frame: Monthly for 6 months ]Risk behavior will be assessed via the the Risk Assessment Battery (RAB) and Addiction Severity Index at baseline and monthly intervals throughout the study for subjects in and out of treatment.
- Other problem severity [ Time Frame: Monthly for 6 months ]Addiction Severity Index (ASI) composite scores will be assessed at baseline and at monthly intervals.
- Counseling engagement [ Time Frame: Weekly for 26 weeks ]Total number of individual and group counseling sessions attended, as well as adherence to scheduled sessions (i.e. attended/scheduled), will be monitored.
- Methadone dose [ Time Frame: Weekly for 26 weeks ]Mean methadone dose, days receiving methadone, and dose adequacy will be evaluated.
- Treatment readiness [ Time Frame: Monthly for 6 months ]Treatment readiness will be assessed via the TCU Treatment Motivation Scales (TMS) at baseline and monthly intervals.
- Treatment satisfaction [ Time Frame: Monthly for 6 months ]The Client Satisfaction Questionnaire (CSQ) will assess treatment satisfaction at baseline and monthly intervals.
- Use of syringe exchange and other community-based services [ Time Frame: Monthly for 6 months ]Days of syringe exchange program (SEP) use, number of syringes exchanged, and use of other community-based medical and psychosocial resources (e.g. emergency room, psychiatric and other treatment facilities, shelters, hospitalization) will be assessed for participants in and out of treatment at baseline and monthly intervals.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01142986
|United States, Maryland|
|Addiction Treatment Services|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Michael Kidorf, Ph.D.||Johns Hopkins University|