NCT00167687

Brief Summary

This double-blind placebo controlled pilot trial will test the hypothesis that prazosin, an alpha-1 adrenergic receptor antagonist, reduced alcohol consumption and alcohol craving in alcohol dependent individuals without Post Traumatic Stress Disorder (PTSD). The intervention period is six weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

February 15, 2008

Status Verified

February 1, 2008

Enrollment Period

2.1 years

First QC Date

September 9, 2005

Last Update Submit

February 13, 2008

Conditions

Alcoholism

Keywords

AlcoholismRandomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

  • Number of days drinking during the six week intervention

    6 weeks

  • Number of drinks per drinking day consumed

    6 weeks

Secondary Outcomes (1)

  • Daily craving intensity over the six week intervention

    six weeks

Study Arms (1)

2

PLACEBO COMPARATOR
Drug: prazosin

Interventions

prazosinDRUG

Pharmacological treatment: In order to prevent the possible side effect of first-dose hypotension, all participants will receive only 1mg of study medication or placebo nightly for the first two days of study participation. Titration will proceed according to the following schedule: Prazosin Dosing: 9 AM 3 PM 9 PM Days 1-2 1 mg (one capsule) Days 3-4 1 mg 1 mg 1 mg Days 5-7 2 mg 2 mg 2 mg Day 8-10 2 mg 2 mg 6 mg Day 11-14 4 mg 4 mg 6 mg Day 15-42 4 mg 4 mg 8 mg

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 years of age or older
  • current DSM-IV diagnosis of alcohol dependence with some use in last 30 days
  • capacity to provide informed consent
  • no planned absences during six week active treatment period that would prevent weekly check-in wiht the study psychiatrist
  • English fluency

You may not qualify if:

  • Score 50 or greater on the PTSD Check List which suggests a current diagnosis of PTSD
  • Psychiatric disorder requiring any medication other than anti-depressants
  • Current diagnosis of opiate dependence or abuse, chronic treatment with any opiate-containing medications during the previous month, or urine positive for opioids
  • Significant acute or chronic medical illness, including unstable angina, recent myocardial infarction, history of congestive heart failure, preexisting hypotension (systolic lower than 110) or orthostatic hypotension (systolic drop greater than 20mmHg after two minutes standing or any drop with dizziness), insulin-dependent diabetes mellitus; chronic renal or hepatic failure, pancreatitis, gout, Meniere's disease, benign positional vertigo, narcolepsy
  • Concomitant use of trazodone, tadalafil or verdenafil
  • History of prazosin-sensitivity
  • Women who are pregnant, nursing infant(s), or of childbearing potential and not using a contraceptive method judged by the investigator to be effective
  • Signs or symptoms of alcohol withdrawal at the time of randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

Related Links

MeSH Terms

Conditions

Alcoholism

Interventions

Prazosin

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Tracy Simpson, PhD

    VA Puget Sound Health Care System

    PRINCIPAL INVESTIGATOR

  • Andrew Saxon, MD

    VA Puget Sound Health Care System

    PRINCIPAL INVESTIGATOR

  • Charles Meredith, MD

    VA Puget Sound Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

September 1, 2005

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

February 15, 2008

Record last verified: 2008-02

Locations

US(1)