Doxazosin an a1 Antagonist for Alcohol Dependence

Launched by BROWN UNIVERSITY · Sep 19, 2011

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.