Comparison of Two Counseling Induction Strategies

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael Kidorf, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01141920
First received: June 10, 2010
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Methadone
Drug Use Disorders
Behavioral: low threshold care
Behavioral: stepped-based care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Two Different Counseling Schedules on Treatment Response of New Admissions to Methadone Maintenance

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • treatment retention [ Time Frame: 120 days ] [ Designated as safety issue: No ]
    The number of days patients remained in treatment over the 120 day study.


Secondary Outcome Measures:
  • Drug use [ Time Frame: weekly observation for 120 days ] [ Designated as safety issue: No ]
    Urinalysis testing is administered weekly, using a random testing schedule. Samples are tested for the presence of opioids, cocaine, and benzodiazepines


Enrollment: 120
Study Start Date: September 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 3-month counseling induction: routine care
Participants assigned to this condition will receive routine stepped-care treatment at ATS. Participants will begin in Step 2 (one counseling session per week), and be advanced to higher intensity care based on missed counseling sessions and drug-positive urine samples. Participants advanced to Step 3 will be scheduled to attend 2 group counseling sessions per week (in addition to individual counseling), and those advanced to Step 4 will be scheduled to attend 8 group counseling sessions per week (in addition to individual counseling). Time of methadone dosing will be based on step of care.
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.
Experimental: 3-month counseling induction: low threshold
Participants assigned to this treatment arm will receive low threshold counseling. These participants will be scheduled to attend one counseling session per month with their individual counselor for the first 3-months. Participants can attend more counseling sessions if they desire, and they can meet with program supervisors to address crisis situations. They can receive methadone dosing any time during the clinic hours (7:30 am-1:15 pm and 4:00 pm - 6:00 pm)
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.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • New admissions to methadone maintenance

Exclusion Criteria:

  • Pregnant
  • Acute medical or psychiatric condition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01141920

Locations
United States, Maryland
Addiction Treatment Services -- Hopkins Bayview
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Michael S Kidorf, Ph.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Michael Kidorf, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01141920     History of Changes
Other Study ID Numbers: da012347-4
Study First Received: June 10, 2010
Last Updated: September 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
treatment retention
methadone maintenance
treatment induction
Retention in methadone maintenance treatment

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on April 21, 2014