Neural Mechanisms of Change During the Treatment of Alcohol Use Disorders With Prazosin

Study Overview
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Brief Summary
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The study uses neurobiological measures through brain imaging, neuropsychological measures, and selfreport measures to try to understand how an effective treatment for alcoholism works. On the whole, less than 50% of people with alcoholism get better with treatment. This study will help researchers develop better treatments for alcoholism because if the investigators know why the treatments the investigators use are working, and in whom the treatments work best, then the investigators may be able to make treatment more effective by targeting treatments to individuals who would be most likely to benefit and by guiding development of more effective treatments in the future.

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Drug: Prazosin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females age 18-65 meeting DSM-IV criteria for alcohol dependence in the past year; seeking but not currently receiving treatment; able to provide voluntary informed consent; have at least 4 drinking days in the past 30 days english-speaking have a primary care physician or psychiatrist willing to continue prazosin if the patient tolerates it well and is finding it beneficial. Exclusion Criteria: severe neurological (e.g., head injury/stroke) conditions, Meniere's disease, narcolepsy, benign positional vertigo, heart disease or unstable angina, history of dysrhythmia/syncope, SBP<110, SBP>160, DBP>110, HR<55, HR>110, irregular heart rhythm, chronic renal or hepatic failure, pancreatitis or insulin-dependent diabetes, or other medical problems requiring immediate attention; schizophrenia, schizoaffective disorder, PTSD, Bipolar I disorder, suicidal thoughts within the last month; current dependence on another drug of abuse (except nicotine); contraindications to MRI (e.g., pacemaker); active legal problems with the potential to result in incarceration; pregnancy or lactation, or child bearing age and not on birth control; currently receiving treatment for alcohol dependence; current use of psychoactive medications including SSRI's and other antidepressants, anti-craving medications, anxiolytics including benzodiazepines, antipsychotics, mood stabilizers or anticonvulsants; history of seizures or DT's during alcohol withdrawal.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prazosin<br>Prazosin titrated to 16 mg daily x 6 weeks | Drug: Prazosin<br> <br> |
| Placebo Comparator: Placebo<br>Placebo X 6 weeks | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Standard Alcoholic Drinks Consumed Per Week (Drinks Per Week) |  | from 2-4 weeks and from 4-6 weeks |