Alcohol Use Disorders in Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT00280813
First received: January 19, 2006
Last updated: October 24, 2008
Last verified: October 2008
  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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Alcohol Use Disorders in Schizophrenia

Resource links provided by NLM:


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
Active Comparator: Supportive Treatment in Alcohol Recovery (STAR) 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  More Information

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

Keywords provided by University of Maryland:
treatment
dual diagnosis

Additional relevant MeSH terms:
Alcohol Drinking
Alcoholism
Schizophrenia
Mood Disorders
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on July 28, 2014