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

Schizophrenia Clinical Trial

Official title:

Behavioral Treatment of Drug Abuse in SPMI Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00295139
• Other study ID #: HP-00041195
• Status: Completed
• Phase: N/A
• Start date: January 2005
• Est. completion date: March 2010

Study information

• Verified date: February 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Mood Disorders
• Schizophrenia
• Substance Dependence
• Substance-Related Disorders

Intervention

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.
• Supportive Treatment in Addiction Recovery (STAR)
Manualized substance abuse treatment as usual
• Critical Time Intervention (CTI)
Case management component

Locations

Country	Name	City	State
United States	Health Care for the Homeless	Baltimore	Maryland
United States	University of Maryland, Baltimore	Baltimore	Maryland
United States	VA Maryland Health Care System	Baltimore	Maryland
United States	Mosaic Community Services	Catonsville	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

Bellack AS, DiClemente CC. Treating substance abuse among patients with schizophrenia. Psychiatr Serv. 1999 Jan;50(1):75-80. Review. — View Citation

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

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinalysis		Baseline, 2 and 4 months, post and 6-month follow-up, and at each treatment session