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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01916941
Other study ID # 1K23AA021156-01A1
Secondary ID
Status Completed
Phase N/A
First received August 1, 2013
Last updated October 12, 2017
Start date September 2013
Est. completion date September 2017

Study information

Verified date October 2017
Source University of New Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date September 2017
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Prazosin

Placebo


Locations

Country Name City State
United States University of New Mexico, Department of Psychiatry Albuquerque New Mexico

Sponsors (1)

Lead Sponsor Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Standard Alcoholic Drinks Consumed Per Week (Drinks Per Week) from 2-4 weeks and from 4-6 weeks
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