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

NCT00744055 | Completed Phase 3 Results DMC

• 1 other identifier: 0801003450
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Dependence; Stress Disorders, Post-Traumatic

Keywords

alcohol dependence; post traumatic stress disorder; treatment; prazosin

Outcome Measures

Primary Outcomes (2)

• Number of Drinking Days

  Using the Timeline Follow Back method, a calendar method for assessing drug and alcohol use

  12 weeks

• Clinician-Administered PTSD Scale

  Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). A higher score is associated with higher severity of PTSD. The score is interpreted as follows: 0-19=Asymptomatic/few symptoms 20-39=Sub-threshold/mild PTSD 40-59=Threshold PTSD/moderate 60-79=Severe PTSD \>80=Extreme PTSD

  12 weeks

Study Arms (2)

Prazosin

EXPERIMENTAL

prazosin (16mg/day)

Drug: Prazosin

Placebo

PLACEBO COMPARATOR

Placebo in identical looking capsule blister packs

Drug: Placebo

Interventions

Prazosin DRUG

prazosin (16mg/day) 2 times a day

Also known as: Minipress

Prazosin

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

Related Publications (1)

• Gandelman E, Petrakis I, Kachadourian L, Ralevski E. Negative Affect Intensity and Hostility in Individuals With Alcohol Use Disorder With or Without Posttraumatic Stress Disorder. J Dual Diagn. 2018 Apr-Jun;14(2):96-101. doi: 10.1080/15504263.2018.1434264. Epub 2018 Apr 25.

  PMID: 29461925 DERIVED

MeSH Terms

Conditions

Alcoholism; Stress Disorders, Post-Traumatic

Interventions

Prazosin

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Elizabeth Ralevski
• Organization: Yale University School Of Medicine Department of Psychiatry

elizabeth.ralevski@yale.edu

2039325711

Study Officials

• Ismene Petrakis, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2008
• First Posted: August 29, 2008
• Study Start: January 1, 2009
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 19, 2020
• Results First Posted: January 18, 2016

Record last verified: 2020-03

Locations

US (1)