NCT01141920

Comparison of Two Counseling Induction Strategies

Comparison of Two Different Counseling Schedules on Treatment Response of New Admissions to Methadone Maintenance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Methadone
• Drug Use Disorders

Interventions

Type	Name	Description
BEHAVIORAL	low threshold care	Low threshold care refers to a service delivery method that reduces the treatment demands for new admissions to substance abuse treatment. In the present study, participants will be scheduled to attend less counseling sessions, and will have greater access to methadone.
BEHAVIORAL	stepped-based care	Stepped-based care is routine treatment at ATS. Participants begin a low intensity care, and are advanced to more intensive levels of care (i.e., more intensive schedules of counseling) based on urine samples and counseling adherence.

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2010-06-11
• Last updated: 2015-09-17

Locations

1 site across 1 country: United States