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Alcohol Use Disorders in Schizophrenia

Primary Purpose

Schizophrenia, Mood Disorders, Alcohol Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supportive Treatment in Addiction Recovery (STAR)
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring treatment, dual diagnosis

Eligibility Criteria

22 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: DSM-IV diagnosis of schizophrenia or schizoaffective disorder OR other severe 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 received payment for mental disability) Current (last month) Alcohol Abuse or Dependence or Alcohol Abuse or Dependence criteria met within the last 3 months as determined by the Structured Clinical Interview for DSM-IV. Ability to provide informed consent Stable housing Exclusion Criteria: Current neurological disorder or cognitive impairment due to head injury or loss of consciousness that would impact ability to effectively participate in the intervention 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 patient is homeless. 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.

Sites / Locations

  • Healthcare for the Homeless
  • University of Maryland, Baltimore
  • VA Maryland Healthcare System
  • Mosaic Community Services Inc.

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Supportive Treatment in Alcohol Recovery (STAR)

Arm Description

Outcomes

Primary Outcome Measures

Symptom ratings, addiction severity, quality of life, social functioning & motivation to change: baseline and post-treatment.

Secondary Outcome Measures

Saliva test & Urinalysis: baseline, post-treatment and at each treatment session.

Full Information

First Posted
January 19, 2006
Last Updated
April 2, 2020
Sponsor
University of Maryland, Baltimore
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00280813
Brief Title
Alcohol Use Disorders in Schizophrenia
Official Title
Treatment of Alcohol Use Disorders in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to evaluate a new treatment to help patients who have problems because of their use of alcohol. The treatment is called Behavioral Treatment for Alcohol Abuse in Schizophrenia (BTAAS).We are interested in determining whether BTAAS is more effective in reducing use than a supportive control treatment.
Detailed Description
Alcohol abuse and dependence in people with schizophrenia is a serious public health problem that is associated with poor treatment compliance, increased rates of relapse, increased levels of violence, and poor overall health and life functioning. Treating alcohol use disorders in people with schizophrenia is especially problematic, as schizophrenia is marked by symptoms and neurocognitive and psychosocial deficits that make it difficult for patients to engage in the higher level cognitive processes or the sustained, self-directed behaviors generally required to reduce drinking. To date there are no interventions for alcohol use disorders with solid empirical support that have been designed for or adapted to meet the needs of this multiply-handicapped population. In this study we will develop and pilot test a multifaceted behavioral intervention for treating schizophrenia patients with alcohol use disorders that will incorporate strategies that have been found to be effective in reducing drinking, but tailor them to meet the needs of this population. The intervention will contain several components, including: (1) pre-treatment motivational interviewing to increase engagement and motivation; (2) short-term goal setting at each session; (3) social skills and alcohol refusal skills training; (4) education and coping skills training for managing depression, stress and other forms of negative affect; (5) relapse prevention training; (6) case management aimed at networking with social supports in the participant's environment and linking patients with activities and social networks in the community in order to create a reinforcing, non-drinking environment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Mood Disorders, Alcohol Abuse, Alcohol Dependence
Keywords
treatment, dual diagnosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive Treatment in Alcohol Recovery (STAR)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Supportive Treatment in Addiction Recovery (STAR)
Primary Outcome Measure Information:
Title
Symptom ratings, addiction severity, quality of life, social functioning & motivation to change: baseline and post-treatment.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Saliva test & Urinalysis: baseline, post-treatment and at each treatment session.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DSM-IV diagnosis of schizophrenia or schizoaffective disorder OR other severe 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 received payment for mental disability) Current (last month) Alcohol Abuse or Dependence or Alcohol Abuse or Dependence criteria met within the last 3 months as determined by the Structured Clinical Interview for DSM-IV. Ability to provide informed consent Stable housing Exclusion Criteria: Current neurological disorder or cognitive impairment due to head injury or loss of consciousness that would impact ability to effectively participate in the intervention 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 patient is homeless. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie Bennett, Ph.D.
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Healthcare for the Homeless
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Maryland, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
VA Maryland Healthcare System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Mosaic Community Services Inc.
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9890583
Citation
Bellack AS, DiClemente CC. Treating substance abuse among patients with schizophrenia. Psychiatr Serv. 1999 Jan;50(1):75-80. doi: 10.1176/ps.50.1.75.
Results Reference
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PubMed Identifier
9801714
Citation
Bellack AS, Gearon JS. Substance abuse treatment for people with schizophrenia. Addict Behav. 1998 Nov-Dec;23(6):749-66. doi: 10.1016/s0306-4603(98)00066-5.
Results Reference
background
Citation
Bennett ME. Interrelationship of substance abuse and mental health problems. In Miller WR & Weisner C (Eds.), Changing substance abuse through health and social systems. New York: Kluwer/Plenum, 2003.
Results Reference
background
Citation
Bennett ME, Barnett, B.Adult psychopathology and diagnosis: Dual-diagnosis. In M. Hersen & SM Turner (Eds), Adult psychopathology and diagnosis, fourth edition. NY: Kluwer/Plenum, 2003.
Results Reference
background
PubMed Identifier
11306219
Citation
Bennett ME, Bellack AS, Gearon JS. Treating substance abuse in schizophrenia. An initial report. J Subst Abuse Treat. 2001 Mar;20(2):163-75. doi: 10.1016/s0740-5472(00)00167-7.
Results Reference
background
Citation
Miller WR, Andrews, NA, Wilbourne P, Bennett ME (1998). A wealth of alternatives: Effective treatments for alcohol problems. In Miller WR and Healther N. (Eds.). Treating addicting behaviors, second edition. NY: Plenum Press, 1998.
Results Reference
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Alcohol Use Disorders in Schizophrenia

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