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

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prazosin
Placebo
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of New Mexico, Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Prazosin

Placebo

Arm Description

Prazosin titrated to 16 mg daily x 6 weeks

Placebo X 6 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 1, 2013
Last Updated
October 12, 2017
Sponsor
University of New Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT01916941
Brief Title
Neural Mechanisms of Change During the Treatment of Alcohol Use Disorders With Prazosin
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prazosin
Arm Type
Active Comparator
Arm Description
Prazosin titrated to 16 mg daily x 6 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo X 6 weeks
Intervention Type
Drug
Intervention Name(s)
Prazosin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of Standard Alcoholic Drinks Consumed Per Week (Drinks Per Week)
Time Frame
from 2-4 weeks and from 4-6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of New Mexico, Department of Psychiatry
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87031
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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