Doxazosin an a1 Antagonist for Alcohol Dependence
Completed · Early Phase 1 · Has a placebo group
Conditions studied: Alcohol Dependence, Anxiety
In brief
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 doxazosin demonstrates a more favorable pharmacokinetic profile than prazosin, but has never been studied for AD. A double-blind placebo-controlled randomized clinical trial was designed in AD individuals seeking outpatient treatment. Doxazosin or matched placebo was titrated to 16 mg/day (or maximum tolerable dose). Drinks per week (DPW) and heavy drinking days (HDD) per week were the primary outcomes. Family history density of alcoholism (FHDA), severity of AD and gender were a priori moderators.
Key facts
- Study ID
- NCT01437046
- Run by
- Brown University
- People needed
- 41
- Starts
- 2011-11-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2025-08-18
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Brown University Center for Alcohol and Addiction Studies — Providence, Rhode Island, United States
- Brown University Center for Alcohol and Addiction Studies — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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