Stress Disorders, Post-TraumaticNCT00244335
Examining the Role of Negative Emotional States on Sedative Drug Use in Individuals With Post-Traumatic Stress Disorder
An observational study of Stress Disorders, Post-Traumatic, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to Jul 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center, San Antonio
San Antonio, Texas, 78284
About this study
Official title: Emotional Control of Sedative Self-Medication in Post-Traumatic Stress Disorder
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.
Read the detailed description
PTSD is a psychiatric illness that occurs following a traumatic event in which there was threat of injury or death to an individual. Common symptoms of PTSD include anxiety, stress, and tension. Some individuals with PTSD use benzodiazepines, a type of sedative medication, or alcohol to alleviate the anxiety associated with the disorder. Past research has shown that the negative feelings experienced by individuals with PTSD may increase the reinforcing effects of antidepressant drugs. Feelings of anxiety act as a stimulus, which leads to drug use; in turn, the anticipated or actual decrease in distress reinforces the drug-taking behavior. Greater amounts of sedative drugs are then needed to decrease subsequent stress and anxiety. The purpose of this study is to understand how negative emotional states affect the reinforcing effects of sedative drugs in individuals with PTSD.
This study will enroll two types of individuals, both of whom have been exposed to an emotional trauma and report using alcohol to reduce emotional distress but who differ in their subsequent development of PTSD. Participants will take part in an initial screening session which will include a physical examination, standardized psychological questionnaires, and review of medical and drug histories. Once enrolled, each participant will take part in 8 experimental session days, with each day of testing separated by at least 48 hours. At the beginning of each session, a breathalyzer and urine test will be used to screen for the presence of alcohol and drugs. On Day 1, participants will take part in an orientation session to familiarize themselves with the laboratory and study procedures. On Days 2 through 4, participants will receive varying doses of alcohol, a placebo drink, a placebo drug, and alprazolam, a type of benzodiazepine medication. On Days 5 through 8, participants will take part in experimental challenges designed to induce various emotional states, including arousal, anxiety, aggression, and anger. They will also complete a monetary reward task to measure the reinforcing effects of drugs. Participants will complete questionnaires several times each day to assess anxiety, anger, drug effects, and drug cravings. Heart rate will be monitored with an electrocardiogram, and electrodes placed on the skin will measure other physiologic measures throughout each session. Participants will receive compensation for completing each experimental session.
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- Post-Traumatic Stress Disorders, PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | PTSD Subjects | |
| 2 | Trauma Controls: subjects who have experienced a trauma but never developed PTSD |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2005 (estimated)
- Study startOct 2000
- Primary completionFeb 2006
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- John Casada, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244335
- Sponsor's protocol ID
- NIDA-00507-1
- Other IDs
- K08-00507-1, DPMC
- Status last verified
- Aug 2008
- First submitted
- 25 Oct 2005
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16814888Casada 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.
PubMed 15684912
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Control of Sedative Self-Medication in Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT00244335
- Acronym / sponsor ID
- NIDA-00507-1
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- Post-Traumatic Stress Disorders, PTSD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- The University of Texas Health Science Center at San Antonio
- Study start
- Oct 2000
- Primary completion
- Feb 2006 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 26 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PTSD is a psychiatric illness that occurs following a traumatic event in which there was threat of injury or death to an individual. Common symptoms of PTSD include anxiety, stress, and tension. Some individuals with PTSD use benzodiazepines, a type of sedative medication, or alcohol to alleviate the anxiety associated with the disorder. Past research has shown that the negative feelings experienced by individuals with PTSD may increase the reinforcing effects of antidepressant drugs. Feelings of anxiety act as a stimulus, which leads to drug use; in turn, the anticipated or actual decrease in distress reinforces the drug-taking behavior. Greater amounts of sedative drugs are then needed to decrease subsequent stress and anxiety. The purpose of this study is to understand how negative emotional states affect the reinforcing effects of sedative drugs in individuals with PTSD.
This study will enroll two types of individuals, both of whom have been exposed to an emotional trauma and report using alcohol to reduce emotional distress but who differ in their subsequent development of PTSD. Participants will take part in an initial screening session which will include a physical examination, standardized psychological questionnaires, and review of medical and drug histories. Once enrolled, each participant will take part in 8 experimental session days, with each day of testing separated by at least 48 hours. At the beginning of each session, a breathalyzer and urine test will be used to screen for the presence of alcohol and drugs. On Day 1, participants will take part in an orientation session to familiarize themselves with the laboratory and study procedures. On Days 2 through 4, participants will receive varying doses of alcohol, a placebo drink, a placebo drug, and alprazolam, a type of benzodiazepine medication. On Days 5 through 8, participants will take part in experimental challenges designed to induce various emotional states, including arousal, anxiety, aggression, and anger. They will also complete a monetary reward task to measure the reinforcing effects of drugs. Participants will complete questionnaires several times each day to assess anxiety, anger, drug effects, and drug cravings. Heart rate will be monitored with an electrocardiogram, and electrodes placed on the skin will measure other physiologic measures throughout each session. Participants will receive compensation for completing each experimental session.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –PTSD Subjects |
| 2 | – | –Trauma Controls: subjects who have experienced a trauma but never developed PTSD |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- Results publication: PubMed 16814888Casada 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.
- Results publication: PubMed 15684912Casada 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Casada, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Disorders, Post-Traumatic, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00244335, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2017.