Status:
COMPLETED
Doxazosin an a1 Antagonist for Alcohol Dependence
Lead Sponsor:
Brown University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Dependence
Anxiety
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
Norepinephrine system represents an important treatment target for alcohol dependence (AD) and the α1 -blocker prazosin may reduce alcohol drinking in rodents and alcoholic patients. The α1 -blocker d...
Detailed Description
Pre-clinical and clinical evidence has clearly demonstrated that the noradrenergic (NE) system is involved in the neurobiology of AD, thus representing an interesting new pharmacotherapy target and th...
Eligibility Criteria
Inclusion
- age ≥18
- females must be post-menopausal for ≥1 year, surgically sterile, or practicing a birth control before entry and throughout the study; have a negative urine pregnancy test at screening and before randomization
- good health (confirmed by medical history, physical, ECG, blood/urine labs)
- DSM-IV diagnosis of AD
- average of ≥4 drinks/d for women and ≥5 drinks/d for men during 30 days within the 90 days prior to screening
- desire to reduce or quit drinking.
Exclusion
- females who are of child bearing potential and not practicing effective birth control
- lifetime DSM-IV diagnosis of schizophrenia, bipolar disorder, or other psychosis
- recent (past 6 months) DSM-IV diagnosis of any anxiety disorder or major depression
- in the investigators' opinion, risk of suicide (e.g. active plan, or recent attempt in last year)
- DSM-IV diagnosis of dependence on any psychoactive substance other than alcohol and nicotine
- positive urine screen for any illegal substance other than marijuana
- history of hospitalization for alcohol intoxication delirium, seizure or alcohol withdrawal delirium
- Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) score ≥10, at any assessment
- treatment with naltrexone, acamprosate, topiramate, disulfiram within 1 month prior to Wk 00
- current use of psychotropic medications or drugs that interfere with doxazosin's metabolism
- use of PDE5 inhibitor erectile dysfunction drugs (e.g. sildenafil)
- treatment with any antihypertensive drug and/or any α-blocker for BPH or sleep problems (e.g. trazodone)
- baseline hypotension
- history of allergy to any α-blocker
- contraindications to take doxazosin (history of fainting and/or syncopal attacks, heart failure, significant liver diseases)
- serious illnesses, e.g. kidney failure, epilepsy.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01437046
Start Date
November 1 2011
End Date
March 1 2015
Last Update
August 18 2025
Active Locations (2)
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1
Brown University Center for Alcohol and Addiction Studies
Providence, Rhode Island, United States, 02903
2
Brown University Center for Alcohol and Addiction Studies
Providence, Rhode Island, United States, 02912