Clinical trial NCT00787735: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Study Focusing on Integrated Versus Non-integrated Psychiatric Care in
Opioid-dependent and Methadone Treated Patients With Other Psychiatric
Diagnoses
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-11-07
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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

Primary outcomes:
measure: Days to first psychiatric appointment
timeFrame: within first 90 days of randomized care
measure: Overall psychiatric counseling attendance compliance rate
timeFrame: 90, 180, and up to 365 days
measure: Psychiatrist session attendance compliance rate
timeFrame: 90, 180, and up to 365 days
measure: Individual and group psychiatric session attendance compliance rate
timeFrame: 90, 180, and up to 365 days
Secondary outcomes:
measure: Level of psychiatric distress
timeFrame: 90, 180, and up to 365 days
measure: Urinalysis results
timeFrame: 90, 180, and up to 365 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Addiction Treatment Services
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Robert K Brooner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: King VL, Brooner RK, Peirce J, Kolodner K, Kidorf M. Challenges and outcomes of parallel care for patients with co-occurring psychiatric disorder in methadone maintenance treatment. J Dual Diagn. 2014;10(2):60-7. doi: 10.1080/15504263.2014.906132.