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Completed

NCT Number: NCT00295139

Behavioral Treatment of Drug Abuse in Severe and Persistent Mental Illness (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.

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Key information

Conditions

Schizophrenia Chemically-Induced Disorders Mental Disorders Mood Disorders Schizophrenia Spectrum and Other Psychotic Disorders Substance Dependence Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Care for the Homeless, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Supportive Treatment in Addiction Recovery (STAR)

Behavioral

Manualized substance abuse treatment as usual

Critical Time Intervention (CTI)

Behavioral

Case management component

Primary outcomes

  1. Urinalysis

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

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Behavioral Treatment of Drug Abuse in SPMI Patients

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Feb 22, 2006
Registry last updated
Feb 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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