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

October 12, 2017 updated by: Claire E Wilcox, University of New Mexico
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87031
        • University of New Mexico, Department of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males and females age 18-65 meeting DSM-IV criteria for alcohol dependence in the past year;
  2. seeking but not currently receiving treatment;
  3. able to provide voluntary informed consent;
  4. have at least 4 drinking days in the past 30 days
  5. english-speaking
  6. have a primary care physician or psychiatrist willing to continue prazosin if the patient tolerates it well and is finding it beneficial.

Exclusion Criteria:

  1. 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;
  2. schizophrenia, schizoaffective disorder, PTSD, Bipolar I disorder, suicidal thoughts within the last month;
  3. current dependence on another drug of abuse (except nicotine);
  4. contraindications to MRI (e.g., pacemaker);
  5. active legal problems with the potential to result in incarceration;
  6. pregnancy or lactation, or child bearing age and not on birth control;
  7. currently receiving treatment for alcohol dependence;
  8. current use of psychoactive medications including SSRI's and other antidepressants, anti-craving medications, anxiolytics including benzodiazepines, antipsychotics, mood stabilizers or anticonvulsants;
  9. history of seizures or DT's during alcohol withdrawal.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Prazosin
Prazosin titrated to 16 mg daily x 6 weeks
Drug: Prazosin
PLACEBO_COMPARATOR: Placebo
Placebo X 6 weeks
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2013

Primary Completion (ACTUAL)

August 1, 2016

Study Completion (ACTUAL)

September 1, 2017

Study Registration Dates

First Submitted

August 1, 2013

First Submitted That Met QC Criteria

August 5, 2013

First Posted (ESTIMATE)

August 6, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 17, 2017

Last Update Submitted That Met QC Criteria

October 12, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1K23AA021156-01A1 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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