Official Title: “Behavioral Treatment of Drug Abuse in SPMI Patients”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2009

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.

Intervention(s) in this Clinical Trial

• 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: Supportive Treatment in Addiction Recovery (STAR)
  • Manualized substance abuse treatment as usual

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Behavioral Treatment for Substance Abuse in SPMI (BTSAS)
• Experimental: 2
  • Behavioral Treatment for Substance Abuse in SPMI (BTSAS) + Critical Time Intervention (CTI)
• Active Comparator: 3
  • Supportive Treatment in Addiction Recovery (STAR)

Primary Measures

• Symptom ratings, quality of life interviews
  • Time Frame: Baseline, Post-treatment, & 6-month Follow-up
    Safety Issue?: No
• Substance Use Event Survey for Schizophrenia
  • Time Frame: 2 & 4 months
    Safety Issue?: No
• Addiction Severity Index (ASI)
  • Time Frame: Baseline
    Safety Issue?: No
• Urinalysis
  • Time Frame: Baseline, 2 & 4-months, post & 6-month follow-up, and at each treatment session
    Safety Issue?: No

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.

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
• being treated in an ACT team (e.g., PACT in WPCC or MHICM in VA)
• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Maryland

Overall Clinical Trial Officials and Contacts

Alan S. Bellack, Ph.D. Principal Investigator University of Maryland School of Medicine  

Overall Contact: Melanie Bennett, Ph.D. 410-706-0722 mbennett@psych.umaryland.edu

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00295139

Study ID Number: 25838

ClinicalTrials.gov Identifier: NCT00295139

Health Authority: United States: Federal Government