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Comparison of Two Counseling Induction Strategies

Primary Purpose

Methadone, Drug Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
low threshold care
stepped-based care
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Methadone focused on measuring treatment retention, methadone maintenance, treatment induction, Retention in methadone maintenance treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • New admissions to methadone maintenance

Exclusion Criteria:

  • Pregnant
  • Acute medical or psychiatric condition

Sites / Locations

  • Addiction Treatment Services -- Hopkins Bayview

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

3-month counseling induction: routine care

3-month counseling induction: low threshold

Arm Description

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.

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)

Outcomes

Primary Outcome Measures

treatment retention
The number of days patients remained in treatment over the 120 day study.

Secondary Outcome Measures

Drug use
Urinalysis testing is administered weekly, using a random testing schedule. Samples are tested for the presence of opioids, cocaine, and benzodiazepines

Full Information

First Posted
June 10, 2010
Last Updated
September 16, 2015
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01141920
Brief Title
Comparison of Two Counseling Induction Strategies
Official Title
Comparison of Two Different Counseling Schedules on Treatment Response of New Admissions to Methadone Maintenance
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methadone, Drug Use Disorders
Keywords
treatment retention, methadone maintenance, treatment induction, Retention in methadone maintenance treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3-month counseling induction: routine care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
3-month counseling induction: low threshold
Arm Type
Experimental
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
low threshold care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
stepped-based care
Intervention Description
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.
Primary Outcome Measure Information:
Title
treatment retention
Description
The number of days patients remained in treatment over the 120 day study.
Time Frame
120 days
Secondary Outcome Measure Information:
Title
Drug use
Description
Urinalysis testing is administered weekly, using a random testing schedule. Samples are tested for the presence of opioids, cocaine, and benzodiazepines
Time Frame
weekly observation for 120 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: New admissions to methadone maintenance Exclusion Criteria: Pregnant Acute medical or psychiatric condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael S Kidorf, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Addiction Treatment Services -- Hopkins Bayview
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

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Comparison of Two Counseling Induction Strategies

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