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OpenTrials
Completed

NCT Number: NCT00787735

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Addiction Treatment Services

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counseling compliance

Behavioral

Rates of attendance to call counseling session over specific time points

Primary outcomes

  1. Days to first psychiatric appointment

    Time frame: within first 90 days of randomized care

  2. 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.

  3. Psychiatrist session attendance compliance rate

    Time frame: 90, 180, and up to 365 days

  4. Individual and group psychiatric session attendance compliance rate

    Time frame: 90, 180, and up to 365 days

Secondary outcomes

  1. Level of psychiatric distress

    Time frame: 90, 180, and up to 365 days

    Measured monthly using the Symptom Checklist 90-Revised (SCL90)

  2. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Services Research: Psychiatric Comorbidity in Drug Abuse

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Nov 7, 2008
Registry last updated
Mar 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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