NCT00244335

Brief Summary

Post-traumatic stress disorder (PTSD) is a serious illness, in which individuals often experience anxiety and stress. Some individuals with PTSD use drugs to alleviate emotional distress. This study will examine the role that negative emotional states play in sedative drug use among individuals with PTSD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2000

Longer than P75 for all trials

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

October 1, 2000

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

January 10, 2017

Status Verified

August 1, 2008

Enrollment Period

5.3 years

First QC Date

October 25, 2005

Last Update Submit

January 9, 2017

Conditions

Stress Disorders, Post-Traumatic

Keywords

Post-Traumatic Stress DisordersPTSD

Study Arms (2)

1

PTSD Subjects

2

Trauma Controls: subjects who have experienced a trauma but never developed PTSD

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

PTSD subjects and subjects who have experienced a trauma but never developed PTSD (Trauma Controls) are being recruited for this study. Recruitment is being conducted through Audie L. Murphy Veterans Administration Hospital and the University of Texas Health Science Center at San Antonio.

You may qualify if:

  • Diagnosis of PTSD with anxiety symptoms, as determined by a score greater than 14 on the Hamilton Anxiety Rating Scale, or a score greater than 18 on the Profile of Mood States-Tension Anxiety Rating Scale
  • Experiences frequent and intense PTSD symptoms
  • Able to spend 6 hours at a time in the research laboratory
  • If a trauma control participant, must have experienced a trauma that meets criterion A for PTSD, but has never developed PTSD
  • Willing to use contraception throughout the study

You may not qualify if:

  • Females who meet DSM-IV diagnostic criteria for premenstrual dysphoric disorder
  • Females who report premenstrual distress that motivates them to use alcohol for relief
  • History of bipolar affective disorder, any psychotic disorder, current major depressive episode, or current primary non-PTSD anxiety disorder (individuals with Axis II diagnoses will not be excluded)
  • Currently enrolled in psychodynamic or cognitive-behavioral therapy
  • Current unstable medical illness
  • Current medical illness treated with psychoactive drugs (e.g., beta blockers)
  • Current medical illness with complicating psychiatric symptoms (e.g., thyroid disease)
  • Requires use of certain medications
  • Current or past history of illicit substance dependence, other than past marijuana abuse or dependence
  • History of tobacco dependence
  • Failure to provide a drug-free urine sample prior to study entry
  • Smokes more than one pack of cigarettes per day or drinks beverages totaling more than 500 mg of caffeine per day
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center, San Antonio

San Antonio, Texas, 78284, United States

Location

Related Publications (2)

  • Casada JH, Roache JD. Dissociation of physiology and behavior in PTSD. Int J Psychophysiol. 2006 Nov;62(2):243-8. doi: 10.1016/j.ijpsycho.2006.04.005. Epub 2006 Jul 11.

    PMID: 16814888RESULT

  • Casada JH, Roache JD. Behavioral inhibition and activation in posttraumatic stress disorder. J Nerv Ment Dis. 2005 Feb;193(2):102-9. doi: 10.1097/01.nmd.0000152809.20938.37.

    PMID: 15684912RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • John Casada, MD

    University of Texas Health Science Center San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

October 25, 2005

First Posted

October 26, 2005

Study Start

October 1, 2000

Primary Completion

February 1, 2006

Study Completion

July 1, 2008

Last Updated

January 10, 2017

Record last verified: 2008-08

Locations

US(1)