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Baltimore, Maryland 21224


Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

R01DA016375


NCT ID:

NCT00787735


Secondary ID:

R01DA016375


Study Acronym:


Brief Title:

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


Official Title:

Services Research: Psychiatric Comorbidity in Drug Abuse


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Johns Hopkins University


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

380


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:January 2004
Completion Date:June 2009
Completion Type:Actual
Primary Completion Date:June 2009
Primary Completion Type:Actual
Verification Date:March 2017
Last Changed Date:March 2, 2017
First Received Date:November 6, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Days to first psychiatric appointment
Time Frame:within first 90 days of randomized care
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Overall psychiatric counseling attendance compliance rate
Time Frame:90, 180, and up to 365 days
Safety Issues:False
Description:Includes attendance to all of the following sessions: psychiatrist, individual psychiatric counseling, and group psychiatric counseling.
Outcome Type:Primary Outcome
Measure:Psychiatrist session attendance compliance rate
Time Frame:90, 180, and up to 365 days
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Individual and group psychiatric session attendance compliance rate
Time Frame:90, 180, and up to 365 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Level of psychiatric distress
Time Frame:90, 180, and up to 365 days
Safety Issues:False
Description:Measured monthly using the Symptom Checklist 90-Revised (SCL90)
Outcome Type:Secondary Outcome
Measure:Urinalysis results
Time Frame:90, 180, and up to 365 days
Safety Issues:False
Description:Urinalysis tests are collected weekly. Results include tests for opioids, cocaine, benzodiazepines, and cannabis.

Study Interventions

Intervention Type:Behavioral
Name:Counseling compliance
Description:Rates of attendance to call counseling session over specific time points
Arm Name:Integrated Care

Study Arms

Study Arm Type:Experimental
Arm Name:Integrated Care
Description: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.
Study Arm Type:Active Comparator
Arm Name:Parallel Care
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Johns Hopkins University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Drug Abuse (NIDA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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