NCT00923923

Brief Summary

Method: This study is designed as an accompaniment to an already funded study - a 12-week treatment trial with prazosin for patients with PTSD and AD. The study design will consist of III phases. In phase I, all subjects will participate in three laboratory sessions to determine their reactivity to stress. Stress reactivity will be measured using: traumatic experiences, stressful non-trauma experiences and neutral experiences, presented randomly. Laboratory sessions will be conducted in an outpatient setting. Phase II is a randomized clinical trial evaluating prazosin versus placebo for 12 weeks in a double-blind, controlled fashion in an outpatient setting. The treatment will last for 12 weeks and outcomes will include symptoms of PTSD and alcohol use. In phase III, subjects will again participate in a laboratory session. This phase of the study will be conducted after at least 6 weeks of treatment while patients are on medication (prazosin or placebo). Hypotheses: Primary: The investigators hypothesize that prazosin will be more effective than placebo in reducing trauma-related stress reactivity in a laboratory paradigm, particularly anxiety, craving for alcohol, and hormonal response, in individuals with PTSD and AD. Secondary: The investigators hypothesize that stress reactivity will have a moderating effect on treatment with prazosin, such that individuals with high levels of stress reactivity will have fewer heavy drinking days, a significant reduction in PTSD symptoms, and shorter time to relapse than individuals with low levels of stress reactivity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

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

January 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 18, 2009

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 14, 2016

Status Verified

December 1, 2016

Enrollment Period

6.5 years

First QC Date

June 12, 2009

Last Update Submit

December 12, 2016

Conditions

Post-traumatic Stress DisorderAlcohol Dependence

Keywords

stress reactivityPTSDalcohol dependencedrinkingcraving

Outcome Measures

Primary Outcomes (1)

  • Anxiety, craving for alcohol and hormone levels

    12 weeks

Secondary Outcomes (1)

  • treatment efficacy

    12 weeks

Study Arms (1)

levels of stress

EXPERIMENTAL
Behavioral: stress

Interventions

stressBEHAVIORAL

compare levels of stress

levels of stress

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male and female patients age 21 to 65.
  • current diagnosis of DSM-IV PTSD (determined by SCID and CAPS and AD (determine by SCID)).
  • participants who drink regularly (determined by TLFB and recorded 90 days prior to the interview), and are not abstinent for more than 2 weeks before participation in the study.
  • are not in an active phase of alcohol withdrawal.
  • are not at risk for suicide.

You may not qualify if:

  • current SCID diagnosis of any psychotic disorder.
  • history of substance dependence (other than alcohol and nicotine) in the last 30 days.
  • 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 \> 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.
  • taking medication for a psychiatric condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Healtcase System

West Haven, Connecticut, 06516, United States

Location

Related Publications (1)

  • Ralevski E, Southwick S, Jackson E, Jane JS, Russo M, Petrakis I. Trauma- and Stress-Induced Response in Veterans with Alcohol Dependence and Comorbid Post-Traumatic Stress Disorder. Alcohol Clin Exp Res. 2016 Aug;40(8):1752-60. doi: 10.1111/acer.13120. Epub 2016 Jul 1.

    PMID: 27368085RESULT

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAlcoholism

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Elizabeth Ralevski, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2009

First Posted

June 18, 2009

Study Start

January 1, 2009

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

December 14, 2016

Record last verified: 2016-12

Locations

US(1)