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

February 2, 2022 updated by: Melanie Bennett, University of Maryland, Baltimore

Behavioral Treatment of Drug Abuse in SPMI Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

293

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Urinalysis
Time Frame: Baseline, 2 and 4 months, post and 6-month follow-up, and at each treatment session
Baseline, 2 and 4 months, post and 6-month follow-up, and at each treatment session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

February 19, 2006

First Submitted That Met QC Criteria

February 19, 2006

First Posted (Estimate)

February 22, 2006

Study Record Updates

Last Update Posted (Actual)

February 18, 2022

Last Update Submitted That Met QC Criteria

February 2, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00041195

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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