Behavioral Treatment of Drug Abuse in Severe and Persistent Mental Illness (SPMI) Patients

NCT00295139 | Completed

• 1 other identifier: HP-00041195
• Study Type: interventional
• Target: 293
• Locations: 1 country
• Sites: 4

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.

Conditions

Schizophrenia; Mood Disorders; Substance Dependence

Keywords

treatment; dual diagnosis

Outcome Measures

Primary Outcomes (1)

• Urinalysis

  Baseline, 2 and 4 months, post and 6-month follow-up, and at each treatment session

Study Arms (3)

1

EXPERIMENTAL

Behavioral Treatment for Substance Abuse in SPMI (BTSAS)

Behavioral: Behavioral Treatment for Substance Abuse in SPMI (BTSAS)

2

EXPERIMENTAL

Behavioral Treatment for Substance Abuse in SPMI (BTSAS) + Critical Time Intervention (CTI)

Behavioral: Behavioral Treatment for Substance Abuse in SPMI (BTSAS); Behavioral: Critical Time Intervention (CTI)

3

ACTIVE COMPARATOR

Supportive Treatment in Addiction Recovery (STAR)

Behavioral: Supportive Treatment in Addiction Recovery (STAR)

Interventions

Behavioral Treatment for Substance Abuse in SPMI (BTSAS) BEHAVIORAL

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.

1; 2

Supportive Treatment in Addiction Recovery (STAR) BEHAVIORAL

Manualized substance abuse treatment as usual

3

Critical Time Intervention (CTI) BEHAVIORAL

Case management component

2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (4)

Health Care for the Homeless

Baltimore, Maryland, 21201, United States

Location

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

VA Maryland Health Care System

Baltimore, Maryland, 21201, United States

Location

Mosaic Community Services

Catonsville, Maryland, 21228, United States

Location

Related Publications (10)

• 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.

  PMID: 9801714 BACKGROUND

• 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.

  PMID: 9890583 BACKGROUND

• 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.

  PMID: 10547116 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 10828416 BACKGROUND

• 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.

  PMID: 11196292 BACKGROUND

• 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.

  PMID: 11306219 BACKGROUND

• 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.

  PMID: 12663840 BACKGROUND

• 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.

  PMID: 12851019 BACKGROUND

• 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.

  PMID: 16585472 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Mood Disorders; Substance-Related Disorders

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Alan S. Bellack, Ph.D.

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 19, 2006
• First Posted: February 22, 2006
• Study Start: January 1, 2005
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: February 18, 2022

Record last verified: 2022-02

Locations

US (4)