Alcohol Use Disorders in Schizophrenia
| Tracking Information | |||||
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| First Received Date ICMJE | January 19, 2006 | ||||
| Last Updated Date | October 24, 2008 | ||||
| Start Date ICMJE | March 2004 | ||||
| Primary Completion Date | May 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
Symptom ratings, addiction severity, quality of life, social functioning & motivation to change: baseline and post-treatment. | ||||
| Change History | Complete list of historical versions of study NCT00280813 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Saliva test & Urinalysis: baseline, post-treatment and at each treatment session. [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Saliva test & Urinalysis: baseleine, post-treatment and at each treatment session. | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Alcohol Use Disorders in Schizophrenia | ||||
| Official Title ICMJE | Treatment of Alcohol Use Disorders in Schizophrenia | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Supportive Treatment in Addiction Recovery (STAR) | ||||
| Study Arm (s) | Active Comparator: Supportive Treatment in Alcohol Recovery (STAR)
Intervention: Behavioral: Supportive Treatment in Addiction Recovery (STAR) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 54 | ||||
| Completion Date | May 2007 | ||||
| Primary Completion Date | May 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 22 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00280813 | ||||
| Other Study ID Numbers ICMJE | 21942 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Melanie Bennett, PhD, University of Maryland School of Medicine | ||||
| Study Sponsor ICMJE | University of Maryland | ||||
| Collaborators ICMJE | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Maryland | ||||
| Verification Date | October 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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