NCT Number: NCT00280813
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.
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Notify MeKey information
Conditions
Age range
22 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Healthcare for the Homeless, Baltimore, Maryland, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Symptom ratings, addiction severity, quality of life, social functioning & motivation to change: baseline and post-treatment.
Time frame: 1 year
Secondary outcomes
-
Saliva test & Urinalysis: baseline, post-treatment and at each treatment session.
Time frame: 1 year
Sponsors and collaborators
Lead sponsor
University of Maryland, Baltimore
Other
Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Registry information
Official study title
Treatment of Alcohol Use Disorders in Schizophrenia
Important dates
- Study start
- 2004
- Primary completion
- 2007
- Study completion
- 2007
- First posted
- Jan 23, 2006
- Registry last updated
- Apr 6, 2020
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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