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OpenTrials
Completed

NCT Number: NCT01916941

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

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.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico, Department of Psychiatry

Albuquerque, New Mexico, 87031, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prazosin

Drug

Placebo

Drug

Primary outcomes

  1. Number of Standard Alcoholic Drinks Consumed Per Week (Drinks Per Week)

    Time frame: from 2-4 weeks and from 4-6 weeks

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Aug 6, 2013
Registry last updated
Oct 17, 2017

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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