Prazosin for Treatment of Patients With Alcohol Dependence (AD) and Post Traumatic Stress Disorder (PTSD). - Full Text View

Sponsor:	Elizabeth Ralevski
Information provided by (Responsible Party):	Elizabeth Ralevski, Yale University
ClinicalTrials.gov Identifier:	NCT00744055

Purpose

Prazosin is an alpha-1 adrenergic receptor antagonist that has been used successfully in the treatment of trauma nightmares and sleep disturbance in combat veterans with PTSD, and alcohol dependence.

The objective of this study is to evaluate the efficacy of prazosin (16mg) versus placebo in reducing alcohol consumption and decreasing symptoms of PTSD in patients with comorbid AD and PTSD.

Condition	Intervention	Phase
Alcohol Dependence Stress Disorders, Post-Traumatic	Drug: Prazosin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	The Use of Prazosin for Treatment of Patients With Alcohol Dependence (AD) and Post Traumatic Stress Disorder (PTSD).

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism Post-Traumatic Stress Disorder

Drug Information available for: Prazosin Prazosin hydrochloride

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

Drinking measures [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
PTSD symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	January 2009
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 comparison between prazosin (16mg/day) vs placebo	Drug: Prazosin prazosin (16mg/day) 2 times a day

Detailed Description:

Background:

There is a high rate of comorbidity with alcohol dependence (AD) and post traumatic stress disorder (PTSD). The rates of PTSD among individuals with AD are at least twice as high as those in the general population. In addition, alcohol dependence is the most common comorbid condition in men with PTSD. Despite this, little is known about how to best treat individuals with comorbid AD and PTSD. The use of an alpha-1 adrenergic receptor antagonist represents a novel approach to treatment that may target symptoms of both AD and PTSD. There is evidence of common neurobiological mechanisms that underlie both AD and PTSD. Prazosin is an alpha-1 adrenergic receptor antagonist that has been used successfully in the treatment of trauma nightmares and sleep disturbance in combat veterans with PTSD, and alcohol dependence.

Objective:

The objective of this study is to evaluate the efficacy of prazosin (16mg) versus placebo in reducing alcohol consumption and decreasing symptoms of PTSD in patients with comorbid AD and PTSD. Methods: Thirty participants with a current diagnosis of AD and PTSD will be enrolled in a 13-week trial. They will be assigned, in a double-blind fashion, to either prazosin or placebo. Significance: This project will be the first to compare prazosin to placebo as effective treatments for reducing alcohol consumption and PTSD symptoms in patients with both AD and PTSD.

Eligibility

Ages Eligible for Study:	21 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females between the ages of 21-65 years old.
Current alcohol dependence, as determined by a structured clinical interview (Structured Clinical Interview for DSM-IV Axis I Disorders) (SCID) (First et al. 1996).
Current PTSD as determined by the Clinician Administered PTSD Scale for DSM-IV(CAPS) (Blake et al. 1995).
Patients with current alcohol dependence, with at least one recent episode of heavy drinking (defined as 5 or more drinks per drinking episode) over the past 14 days.
Medically and neurologically healthy on the basis of history, physical examination, EKG, screening laboratories (CBC w/ differential, TSH, Free-T4, ASAT, ALAT, GGT, BUN, creatinine, calcium, phosphorous, magnesium, total protein, albumin, electrolytes, VDRL, urinalysis, beta-HCG).
For women, negative pregnancy test and use of acceptable method of contraception.

Exclusion Criteria:

Females who are pregnant or lactating.
Individuals with a current unstable medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology (LFT 5 times normal, abnormal BUN and creatinine, and unmanaged hypertension with BP more than 200/120) which in the opinion of the physician would preclude the patient from fully cooperating or be of potential harm during the course of the study.
Patients who meet current SCID criteria for the following major Axis I diagnoses (Bipolar Disorders, Schizophrenia and Schizophrenia-type Disorders).
History of substance dependence (other than alcohol, cocaine, tobacco or cannabis) by DSM-IV criteria in the last 30 days.
Individuals taking mood stabilizers and antipsychotic medications.
Individuals with a history of sensitivity to quinazolines or prazosin.
Individuals taking medications thought to influence alcohol consumption (naltrexone, disulfiram, acamprosate).
Individuals taking adrenergic medication (e.g. clonidine).
Agents that may interact with prazosin such as drugs with CNS depressant effects including tizanidine and xyrem.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744055

Contacts

Contact: Elizabeth Ralevski, Ph.D.

203-932-5711 ext 4282

elizabeth.ralevski@yale.edu

Locations

United States, Connecticut
VA Connecticut Healthcare System	Recruiting
West Haven, Connecticut, United States, 06516
Contact: Elizabeth Ralevski, Ph.D. 203-932-5711 ext 4282 elizabeth.ralevski@yale.edu

Sponsors and Collaborators

Elizabeth Ralevski

Investigators

Principal Investigator:

Ismene Petrakis, MD

Yale University

More Information

No publications provided

Responsible Party:	Elizabeth Ralevski, Assistant Professor, Yale University
ClinicalTrials.gov Identifier:	NCT00744055 History of Changes
Other Study ID Numbers:	00032
Study First Received:	August 28, 2008
Last Updated:	January 26, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

alcohol dependence
post traumatic stress disorder
treatment
prazosin

Additional relevant MeSH terms:

Alcoholism
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Anxiety Disorders
Prazosin
Antihypertensive Agents
Cardiovascular Agents

Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2012