Comparison of Two Counseling Induction Strategies
Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Methadone; Drug Use Disorders
Intervention: low threshold care (Behavioral); stepped-based care (Behavioral)
Phase: N/A
Status: Completed
Sponsored by: Johns Hopkins University Official(s) and/or principal investigator(s):
Michael S Kidorf, Ph.D., Principal Investigator, Affiliation: Johns Hopkins University
Summary
New admissions (n = 120) to the Addiction Treatment Services (ATS) will be stabilized on
methadone and randomly assigned to one of two induction conditions: 1) routine stepped care,
or 2) low threshold stepped care. All participants will continue with routine stepped care
in month 4. Treatment retention is the primary outcome measure, while drug use (measured
via weekly urinalysis testing) is the major secondary outcome.
Clinical Details
Official title: Comparison of Two Different Counseling Schedules on Treatment Response of New Admissions to Methadone Maintenance
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: treatment retention
Secondary outcome: Drug use
Detailed description:
This randomized clinical trial will evaluate two induction strategies for helping
out-of-treatment opioid abusers transition to methadone maintenance treatment. All study
participants (n = 120) will be new admissions to the Addiction Treatment Services at Hopkins
Bayview (ATS), stabilized on 80 mg of methadone, and randomly assigned to one of two study
conditions. The experimental induction condition will receive low threshold stepped care
(LTSC) for the first 3-month of treatment that reduces the counseling demands of maintenance
treatment (i. e., one counseling session / month). This condition will be compared to routine
stepped care (RSC) for the first 3-months, which provides escalating intensity of counseling
schedules contingent on drug use or poor adherence. RSC is routine treatment at ATS. All
participants will receive routine stepped care following the 3-month induction phase, and
will have the opportunity to remain in treatment at ATS following study participation.
Participation is for 4-months. Retention is the primary outcome. Participants will also
submit urine samples weekly on a random schedule each month. We hypothesize that LTSC
participants will exhibit better retention than RSC participants, and that both conditions
will exhibit reductions in drug use compared to baseline.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- New admissions to methadone maintenance
Exclusion Criteria:
- Pregnant
- Acute medical or psychiatric condition
Locations and Contacts
Addiction Treatment Services -- Hopkins Bayview, Baltimore, Maryland 21224, United States
Additional Information
Starting date: September 2008
Last updated: September 19, 2013
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