DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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


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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017