Behavioral Treatment of Drug Abuse in Severe and Persistent Mental Illness (SPMI) Patients - Full Text View

Sponsor:	University of Maryland
Collaborator:	National Institute on Drug Abuse (NIDA)
Information provided by:	University of Maryland
ClinicalTrials.gov Identifier:	NCT00295139

Purpose

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.

Condition	Intervention	Phase
Schizophrenia Mood Disorders Substance Dependence	Behavioral: Behavioral Treatment for Substance Abuse in SPMI (BTSAS) Behavioral: Supportive Treatment in Addiction Recovery (STAR) Behavioral: Critical Time Intervention (CTI)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Behavioral Treatment of Drug Abuse in SPMI Patients

Resource links provided by NLM:

MedlinePlus related topics: Mental Disorders Schizophrenia

U.S. FDA Resources

Further study details as provided by University of Maryland:

Primary Outcome Measures:

Urinalysis [ Time Frame: Baseline, 2 and 4 months, post and 6-month follow-up, and at each treatment session ] [ Designated as safety issue: No ]

Estimated Enrollment:	307
Study Start Date:	January 2005
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Behavioral Treatment for Substance Abuse in SPMI (BTSAS)	Behavioral: Behavioral Treatment for Substance Abuse in SPMI (BTSAS) Multifaceted treatment for substance abuse in dual disordered patients which contains 6 components: 1) a urinalysis contingency to enhance motivation to change and increase the salience of goals; 2) structured goal setting to identify realistic, short term goals for decreased substance use; 3) motivational interviewing to enhance motivation to reduce use; 4) social skills and drug refusal skills to enable development of relationships with people who do not use drugs, and to provide success experiences that can increase self-efficacy for change; 5) education about the reasons for substance use and the particular dangers of substance use for people with SPMI; and 6) relapse prevention training that focuses on behavioral skills for coping with urges and dealing with high risk situations and lapses. BTSAS is specifically structured to reduce the load on memory and attention, and minimize demands on higher level cognitive processes.
Experimental: 2 Behavioral Treatment for Substance Abuse in SPMI (BTSAS) + Critical Time Intervention (CTI)	Behavioral: Behavioral Treatment for Substance Abuse in SPMI (BTSAS) Multifaceted treatment for substance abuse in dual disordered patients which contains 6 components: 1) a urinalysis contingency to enhance motivation to change and increase the salience of goals; 2) structured goal setting to identify realistic, short term goals for decreased substance use; 3) motivational interviewing to enhance motivation to reduce use; 4) social skills and drug refusal skills to enable development of relationships with people who do not use drugs, and to provide success experiences that can increase self-efficacy for change; 5) education about the reasons for substance use and the particular dangers of substance use for people with SPMI; and 6) relapse prevention training that focuses on behavioral skills for coping with urges and dealing with high risk situations and lapses. BTSAS is specifically structured to reduce the load on memory and attention, and minimize demands on higher level cognitive processes. Behavioral: Critical Time Intervention (CTI) Case management component
Active Comparator: 3 Supportive Treatment in Addiction Recovery (STAR)	Behavioral: Supportive Treatment in Addiction Recovery (STAR) Manualized substance abuse treatment as usual

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

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295139

Locations

United States, Maryland
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
VA Maryland Health Care System
Baltimore, Maryland, United States, 21201
Health Care for the Homeless
Baltimore, Maryland, United States, 21201
Mosaic Community Services
Catonsville, Maryland, United States, 21228

Sponsors and Collaborators

University of Maryland

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Alan S. Bellack, Ph.D.

University of Maryland

More Information

Publications:

Bellack AS, Gearon JS. Substance abuse treatment for people with schizophrenia. Addict Behav. 1998 Nov-Dec;23(6):749-66. Review.

Bellack, A.S., & DiClemente, C.C. (1999). Treating substance abuse among patients with schizophrenia. Psychiatric Services. 50, 75-80. Reprinted in special compendium on treatment of mental illness and substance abuse.

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. Review.

Bellack, A.S. (2000) Behavioral treatment for substance abuse in schizophrenia. The Addictions Newsletter, 7, 20-22

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.

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.

Bennett ME, Bellack AS, Gearon JS. Treating substance abuse in schizophrenia. An initial report. J Subst Abuse Treat. 2001 Mar;20(2):163-75.

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.

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.

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.

Responsible Party:	Alan S. Bellack, PhD, University of Maryland, Baltimore
ClinicalTrials.gov Identifier:	NCT00295139 History of Changes
Other Study ID Numbers:	HP-00041195
Study First Received:	February 19, 2006
Last Updated:	December 17, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Maryland:

treatment
dual diagnosis

Additional relevant MeSH terms:

Substance-Related Disorders
Schizophrenia
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on February 09, 2012