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

Not Applicable

Completed

• Conditions: Substance Dependence; Mood Disorders; Schizophrenia
• Interventions: Behavioral: Behavioral Treatment for Substance Abuse in SPMI (BTSAS); Behavioral: Supportive Treatment in Addiction Recovery (STAR); Behavioral: Critical Time Intervention (CTI)

• Registration Number: NCT00295139
• Lead Sponsor: University of Maryland, Baltimore

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.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2006-02-19
• Study First Submitted QC: 2006-02-19
• Study First Posted: 2006-02-22
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 293

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Behavioral Treatment for Substance Abuse in SPMI (BTSAS)	Behavioral Treatment for Substance Abuse in SPMI (BTSAS) + Critical Time Intervention (CTI)
1	Behavioral Treatment for Substance Abuse in SPMI (BTSAS)	Behavioral Treatment for Substance Abuse in SPMI (BTSAS)
2	Critical Time Intervention (CTI)	Behavioral Treatment for Substance Abuse in SPMI (BTSAS) + Critical Time Intervention (CTI)
3	Supportive Treatment in Addiction Recovery (STAR)	Supportive Treatment in Addiction Recovery (STAR)

Primary Outcome Measures

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

Trial Locations

Locations (4)

University of Maryland, Baltimore; 🇺🇸 Baltimore, Maryland, United States

VA Maryland Health Care System; 🇺🇸 Baltimore, Maryland, United States

Health Care for the Homeless; 🇺🇸 Baltimore, Maryland, United States

Mosaic Community Services; 🇺🇸 Catonsville, Maryland, United States