Improving Delivery of Mental Health Services for Patients With Drug Use and Other Behavioral and Emotional Problems

March 2, 2017 updated by: Robert Brooner, Johns Hopkins University

Services Research: Psychiatric Comorbidity in Drug Abuse

This research is being done to:

  • identify any emotional, behavioral or other troubling psychological problems that some people have who are seeking and receiving treatment for heroin or other drug use problems,
  • learn if providing additional psychiatric treatment services in the ATS drug abuse treatment program is as beneficial for and acceptable to patients as referring them to the Bayview Community Psychiatry Program to get help for their emotional, behavioral and other psychological problems.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will rigorously and systematically evaluate an integrated service delivery approach using a design that reduces many of the methodological limitations in earlier work. Study participants will include opioid abusers with a current psychiatric disorder. All study participants will receive comprehensive drug abuse treatment that includes adequate daily doses of methadone. Study participants will be randomly assigned to either an onsite and fully Integrated Substance Abuse and Psychiatric Care condition (ISAP-Integrated) or an offsite and non-integrated Parallel Substance Abuse and Psychiatric Care condition (PSAP-Parallel). Patients assigned to the ISAP condition will receive all of their ambulatory psychiatric care in the ATS treatment program; those assigned to the PSAP condition will be referred for matched "doses" of psychiatric care to the Community Psychiatry Program, which is located on the same campus as the ATS program. All drug abuse treatment services will be provided in the ATS program. Patients will be evaluated for 12 months on a range of outcome measures, including psychiatric medication and therapy adherence, drug abuse treatment adherence, changes in psychiatric symptoms, including posttraumatic stress disorder (PTSD), drug use, exposure to traumatic events, psychosocial functioning, and retention in both psychiatric and drug abuse treatment.

Study Type

Interventional

Enrollment (Actual)

380

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Addiction Treatment Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • DSM-IV criteria for current opioid physical dependence
  • SAMSA Center for Substance Abuse Treatment - CSAT guidelines for maintenance on methadone or another approved opioid agonist
  • have a current DSM-IV psychiatric disorder that is eligible for reimbursement in the Health Choice, Public Mental Health System (e.g., schizophrenia, mood disorders, anxiety disorders, personality disorders, adjustment disorder)
  • express an interest in receiving psychiatric treatment for the problem.

Exclusion Criteria:

  • pregnant
  • acute medical problem that requires immediate and intense management (e.g., AIDS defining illness, tuberculosis, other serious and unstable medical disorder)
  • delirium, dementia or mental retardation
  • already receiving standard outpatient psychiatric care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Integrated Care
Integrated Substance Abuse and Psychiatric Care (ISAP). Subjects received both their substance abuse and psychiatric care within the ATS clinic. Counseling compliance will be measured over time.
Behavioral: Counseling compliance
Rates of attendance to call counseling session over specific time points
Active Comparator: Parallel Care
Parallel Substance Abuse and Psychiatric Care (PSAP). Subjects received their substance abuse treatment at the ATS clinic. Their psychiatric care was received at Community Psychiatry. Counseling compliance will be measured over time.
Behavioral: Counseling compliance
Rates of attendance to call counseling session over specific time points

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days to first psychiatric appointment
Time Frame: within first 90 days of randomized care
within first 90 days of randomized care
Overall psychiatric counseling attendance compliance rate
Time Frame: 90, 180, and up to 365 days
Includes attendance to all of the following sessions: psychiatrist, individual psychiatric counseling, and group psychiatric counseling.
90, 180, and up to 365 days
Psychiatrist session attendance compliance rate
Time Frame: 90, 180, and up to 365 days
90, 180, and up to 365 days
Individual and group psychiatric session attendance compliance rate
Time Frame: 90, 180, and up to 365 days
90, 180, and up to 365 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of psychiatric distress
Time Frame: 90, 180, and up to 365 days
Measured monthly using the Symptom Checklist 90-Revised (SCL90)
90, 180, and up to 365 days
Urinalysis results
Time Frame: 90, 180, and up to 365 days
Urinalysis tests are collected weekly. Results include tests for opioids, cocaine, benzodiazepines, and cannabis.
90, 180, and up to 365 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Robert K Brooner, Ph.D., Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

November 6, 2008

First Submitted That Met QC Criteria

November 6, 2008

First Posted (Estimate)

November 7, 2008

Study Record Updates

Last Update Posted (Actual)

March 6, 2017

Last Update Submitted That Met QC Criteria

March 2, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DA016375 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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