NCT01141920

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2010

Completed
Last Updated

September 17, 2015

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

June 10, 2010

Last Update Submit

September 16, 2015

Conditions

MethadoneDrug Use Disorders

Keywords

treatment retentionmethadone maintenancetreatment inductionRetention in methadone maintenance treatment

Outcome Measures

Primary Outcomes (1)

  • treatment retention

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

    120 days

Secondary Outcomes (1)

  • Drug use

    weekly observation for 120 days

Study Arms (2)

3-month counseling induction: routine care

ACTIVE COMPARATOR

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

3-month counseling induction: low threshold

EXPERIMENTAL

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

Interventions

low threshold careBEHAVIORAL

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.

3-month counseling induction: low threshold
stepped-based careBEHAVIORAL

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.

3-month counseling induction: routine care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • New admissions to methadone maintenance

You may not qualify if:

  • Pregnant
  • Acute medical or psychiatric condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addiction Treatment Services -- Hopkins Bayview

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Michael S Kidorf, Ph.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 10, 2010

First Posted

June 11, 2010

Study Start

September 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

September 17, 2015

Record last verified: 2015-09

Locations

US(1)