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

NCT01916941 | Completed Results DMC

• 1 other identifier: 1K23AA021156-01A1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

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

  from 2-4 weeks and from 4-6 weeks

Study Arms (2)

Prazosin

ACTIVE COMPARATOR

Prazosin titrated to 16 mg daily x 6 weeks

Drug: Prazosin

Placebo

PLACEBO COMPARATOR

Placebo X 6 weeks

Drug: Placebo

Interventions

Prazosin DRUG

Prazosin

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico, Department of Psychiatry

Albuquerque, New Mexico, 87031, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Prazosin

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Claire Wilcox
• Organization: University of New Mexico

cewilcox@salud.unm.edu

505-272-2333

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: August 6, 2013
• Study Start: September 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2017
• Last Updated: October 17, 2017
• Results First Posted: October 17, 2017

Record last verified: 2017-10

Locations

US (1)