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

January 19, 2006
October 24, 2008
March 2004
May 2007   (final data collection date for primary outcome measure)
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 ]
Symptom ratings, addiction severity, quality of life, social functioning & motivation to change: baseline and post-treatment.
Complete list of historical versions of study NCT00280813 on ClinicalTrials.gov Archive Site
Saliva test & Urinalysis: baseline, post-treatment and at each treatment session. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Saliva test & Urinalysis: baseleine, post-treatment and at each treatment session.
Not Provided
Not Provided
 
Alcohol Use Disorders in Schizophrenia
Treatment of Alcohol Use Disorders in Schizophrenia

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Schizophrenia
  • Mood Disorders
  • Alcohol Abuse
  • Alcohol Dependence
Behavioral: Supportive Treatment in Addiction Recovery (STAR)
Active Comparator: Supportive Treatment in Alcohol Recovery (STAR)
Intervention: Behavioral: Supportive Treatment in Addiction Recovery (STAR)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
May 2007
May 2007   (final data collection date for primary outcome measure)

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.
Both
22 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00280813
21942
No
Melanie Bennett, PhD, University of Maryland School of Medicine
University of Maryland
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Melanie Bennett, Ph.D. University of Maryland
University of Maryland
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP