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Alcohol Use Disorders in Schizophrenia
This study has been completed.
Sponsors and Collaborators: University of Maryland
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: University of Maryland
ClinicalTrials.gov Identifier: NCT00280813
  Purpose

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.


Condition Intervention
Schizophrenia
Mood Disorders
Alcohol Abuse
Alcohol Dependence
Behavioral: Supportive Treatment in Addiction Recovery (STAR)

MedlinePlus related topics: Alcohol Consumption Alcoholism Schizophrenia
Drug Information available for: Ethanol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Treatment of Alcohol Use Disorders in Schizophrenia

Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Symptom ratings, addiction severity, quality of life, social functioning & motivation to change: baseline and post-treatment. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Saliva test & Urinalysis: baseline, post-treatment and at each treatment session. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: March 2004
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Supportive Treatment in Alcohol Recovery (STAR): Active Comparator Behavioral: Supportive Treatment in Addiction Recovery (STAR)

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.

  Eligibility

Ages Eligible for Study:   22 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00280813

Locations
United States, Maryland
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
VA Maryland Healthcare System
Baltimore, Maryland, United States, 21201
Healthcare for the Homeless
Baltimore, Maryland, United States, 21201
Mosaic Community Services Inc.
Catonsville, Maryland, United States, 21228
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Melanie Bennett, Ph.D. University of Maryland School of Medicine
  More Information

Publications:
Bellack AS, DiClemente CC. Treating substance abuse among patients with schizophrenia. Psychiatr Serv. 1999 Jan;50(1):75-80. Review.
Bellack AS, Gearon JS. Substance abuse treatment for people with schizophrenia. Addict Behav. 1998 Nov-Dec;23(6):749-66. Review.
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.
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.
Bennett ME, Bellack AS, Gearon JS. Treating substance abuse in schizophrenia. An initial report. J Subst Abuse Treat. 2001 Mar;20(2):163-75.
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.

Responsible Party: University of Maryland School of Medicine ( Melanie Bennett, PhD )
Study ID Numbers: 21942
Study First Received: January 19, 2006
Last Updated: October 24, 2008
ClinicalTrials.gov Identifier: NCT00280813  
Health Authority: United States: Federal Government

Keywords provided by University of Maryland:
treatment
dual diagnosis

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Alcoholism
Substance-Related Disorders
Mood Disorders
Disorders of Environmental Origin
Psychotic Disorders
Alcohol-Related Disorders
Alcohol Drinking
Schizophrenia and Disorders with Psychotic Features
Ethanol

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 15, 2009