Clinical trial NCT00295139: Behavioral Treatment of Drug Abuse in Severe and Persistent Mental Illness (SPMI) Patients
Official title: Behavioral Treatment of Drug Abuse in SPMI Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Mood Disorders
Substance Dependence
Keywords: treatment
dual diagnosis
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2006-02-22
Enrollment: 293
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to determine if the multifaceted treatment for substance abuse in dual disordered patients is more effective in reducing drug use than a supportive control treatment. The researchers will also determine if adding a case management component (Critical Time Intervention; CTI) to the intervention will increase treatment engagement and retention.

Detailed description: Drug and alcohol abuse by people with severe and persistent mental illness (SPMI) is one of the most significant problems facing the public mental health system. We have been conducting a project to develop a multifaceted treatment for substance abuse in dual disordered patients (Behavioral Treatment for Substance Abuse in Schizophrenia; BTSAS). Results have shown that the treatment is well-accepted by patients and has a significant effect on drug use. While BTSAS has been effective at retaining subjects and fostering reduced drug use, a major problem that occurred was low rates of engagement. The main purpose of this study is to determine if BTSAS is more effective in reducing drug use than a supportive control treatment and to determine if adding a case management component (Critical Time Intervention; CTI) will increase treatment engagement and retention in BTSAS.

Eligibility criteria: Inclusion Criteria:

* a diagnosis of schizophrenia or schizoaffective disorder or a diagnosis of other severe mental disorder including bipolar disorder, major depression, or severe anxiety disorder (by definition, the patient has worked 25% or less of the past year; and/or the patient receives payment for mental disability)
* a diagnosis of current dependence for opiates, cocaine, or marijuana
* ability and willingness to attend treatment sessions for 6 months
* ability and willingness to provide consent to participate
* enrolled in mental health care

Exclusion Criteria:

* documented history of severe neurological disorder or severe head trauma with loss of consciousness
* severe or profound mental retardation as indicated by chart review
* inability to effectively participate in the baseline assessments due to intoxication or psychiatric symptoms on two successive appointments
* had a substantial trial in either intervention of the Evaluation of Behavioral Treatment for Substance Abuse in Schizophrenia protocol (H-20680)
* inability to attend group sessions due to transportation or other logistical problems
* inability to attend scheduled treatment sessions on a regular basis for any reason, or to appropriately participate in research activities due to behavioral or psychiatric problems

Primary outcomes:
measure: Urinalysis
timeFrame: Baseline, 2 and 4 months, post and 6-month follow-up, and at each treatment session
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Health Care for the Homeless
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
city: Baltimore
country: United States
facility: VA Maryland Health Care System
state: Maryland
city: Catonsville
country: United States
facility: Mosaic Community Services
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Alan S. Bellack, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bellack AS, Gearon JS. Substance abuse treatment for people with schizophrenia. Addict Behav. 1998 Nov-Dec;23(6):749-66. doi: 10.1016/s0306-4603(98)00066-5.
citation: Bellack AS, DiClemente CC. Treating substance abuse among patients with schizophrenia. Psychiatr Serv. 1999 Jan;50(1):75-80. doi: 10.1176/ps.50.1.75.
citation: Gearon JS, Bellack AS. Women with schizophrenia and co-occurring substance use disorders: an increased risk for violent victimization and HIV. Community Ment Health J. 1999 Oct;35(5):401-19. doi: 10.1023/a:1018778310859.
citation: Bellack, A.S. (2000) Behavioral treatment for substance abuse in schizophrenia. The Addictions Newsletter, 7, 20-22
citation: Gearon JS, Bellack AS. Sex differences in illness presentation, course, and level of functioning in substance-abusing schizophrenia patients. Schizophr Res. 2000 May 25;43(1):65-70. doi: 10.1016/s0920-9964(99)00175-9.
citation: Gearon JS, Bellack AS, Rachbeisel J, Dixon L. Drug-use behavior and correlates in people with schizophrenia. Addict Behav. 2001 Jan-Feb;26(1):51-61. doi: 10.1016/s0306-4603(00)00084-8.
citation: Bennett ME, Bellack AS, Gearon JS. Treating substance abuse in schizophrenia. An initial report. J Subst Abuse Treat. 2001 Mar;20(2):163-75. doi: 10.1016/s0740-5472(00)00167-7.
citation: Gearon JS, Kaltman SI, Brown C, Bellack AS. Traumatic life events and PTSD among women with substance use disorders and schizophrenia. Psychiatr Serv. 2003 Apr;54(4):523-8. doi: 10.1176/appi.ps.54.4.523.
citation: Gearon JS, Nidecker M, Bellack A, Bennett M. Gender differences in drug use behavior in people with serious mental illnesses. Am J Addict. 2003 May-Jun;12(3):229-41.
citation: Bellack AS, Bennett ME, Gearon JS, Brown CH, Yang Y. A randomized clinical trial of a new behavioral treatment for drug abuse in people with severe and persistent mental illness. Arch Gen Psychiatry. 2006 Apr;63(4):426-32. doi: 10.1001/archpsyc.63.4.426.