Stress Disorders, Post-TraumaticPhase 2NCT03339258

A Randomized Controlled Trial of Doxazosin for Nightmares, Sleep Disturbance, and Non-Nightmare Clinical Symptoms in PTSD

A Phase 2 study testing Doxazosin Mesylate, Extended Release in people with Stress Disorders, Post-Traumatic, run by San Francisco Veterans Affairs Medical Center at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

This randomized, double-blind, placebo-controlled trial of doxazosin will assess doxazosin's effectiveness for PTSD nightmares, subjective sleep quality, and non-nightmare PTSD symptoms in adult men and women veterans with full and partial-syndromal PTSD. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Stress Disorders, Post-Traumatic
What is being tested?: Doxazosin Mesylate, Extended Release
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteUnited States
Study dates: 15 Apr 2018to Jun 2024
Phase: Phase 2
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

U.S. military veteran or civilian;
age 18-75 and
current full syndromal PTS as indexed by the CAPS-5 (Clinician-administered PTSD scale) or have a current CAPS-5 score ≥ 20, and CAPS-IV recurrent distressing dreams item of ≥ 3; or a CAPS-5 score ≥ 12, and CAPS-IV recurrent distressing dream item of ≥ 4.

Who cannot join

DSM-5 current moderate to severe alcohol or drug use disorder in the last 3 months; moderate alcohol or drug use disorder in the last 3 months will be reviewed on a case-by-case basis;
history of any psychiatric disorder with active psychosis or mania in the past 5 years;
exposure to trauma within the last 3 months;
prominent suicidal or homicidal ideation;
score of 16 or greater AHI based on ApneaLink data analysis in the absence of effective sleep treatment (such as CPAP or oral device)
neurologic disorder or systemic illness affecting central nervous system function;

Show all 15Show fewer

chronic or unstable medical illness including unstable angina, myocardial infarction within the past 6 months, congestive heart failure, preexisting hypotension or standing systolic blood pressure < 100 mmHg at eligibility (V0); orthostatic hypotension defined as orthostatic systolic decrease after 3 minutes standing >20 mmHg or any BP decrease accompanied by lightheadedness; complete heart block or arrhythmia on ECG; chronic renal or hepatic failure, and pancreatitis;
history of priapism or refusal to hold off on as needed phosphodiesterase inhibitors;
pregnancy, breastfeeding and/or refusal to use effective birth control (female participants);
previous adverse reaction to an alpha-1-antagonist;
current use of a medication with alpha-1 blocking properties for insomnia, alpha-1 antagonists, alpha-2 agonists, boceprevir; midodrine; and
use of yohimbine, Ma huang or other non-FDA approved substances or herbal remedies that the investigators consider pose a risk to participation
homelessness (includes living in a temporary shelter);
subjects who, in the opinion of the investigator, are otherwise unsuitable for a study of this type.
Participants taking SSRIs, duloxetine, bupropion, mirtazapine, and venlafaxine may be included if they have been on a stable dose for 4 weeks. Participants may be included if they are in psychotherapy treatment as long as they do not participate in evidence-based trauma-focused or nightmare-focused psychotherapy (such as cognitive processing therapy, prolonged exposure therapy, or imagery rehearsal therapy) while in the trial. Participants who are normotensive and do not have orthostatic hypotension while on stable-dose beta-blocker may be included in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

San Francisco VA Medical Center
San Francisco, California, 94121

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of Doxazosin for Nightmares, Sleep Disturbance, and Non-Nightmare Clinical Symptoms in Post-Traumatic Stress

Read the detailed description

This study will involve a randomized, double-blind, placebo-controlled, flexible dose trial of doxazosin (1-10mg) for PTSD nightmares, sleep disturbance and overall PTSD symptoms. The target sample will consist of 60 male and female subjects with chronic PTSD symptoms and prominent nightmares randomly assigned to receive doxazosin (n=30) or placebo (n=30). Participants will be enrolled at the San Francisco VA Medical Center. Following baseline consent procedures, eligibility assessments, and 1-week of baseline assessments including self-report surveys, actigraphy, and at-home EEG (Sleep Profiler), all subjects will initiate doxazosin or equivalently marked placebo at 1mg at bedtime. Subjects will undergo a 4-week titration phase during which doxazosin or placebo may be increased to a maximum dose of 10mg (or equivalently marked placebo) at bedtime based on symptoms and tolerability. After the 4-week titration phase, subjects will continue at stable dose of study medication for a 4-week stable dose phase. Subjects will be asked to complete sleep diaries daily during their participation in the study. In the last week of the stable dose phase, participants will undergo an additional week of at-home sleep monitoring using actigraphy, complete end of treatment surveys, and undergo end-of-treatment clinical assessments and discontinuation of study medication. After discontinuation of study medication, participants will complete three additional days of sleep diaries.

Conditions: Stress Disorders, Post-Traumatic
Being tested: Doxazosin Mesylate, Extended Release, Placebo
Keywords: Posttraumatic Stress Disorder, Post-traumatic Stress Disorder, PTSD, Doxazosin, Nightmares, Sleep Disturbance
Medical subject headings: Stress Disorders, Post-Traumatic, Parasomnias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Doxazosin Mesylate, Extended ReleaseDrug
Also called Cardura XL
Doxazosin is FDA-approved for the treatment of hypertension and urinary outflow problems associated with benign prostatic hyperplasia. The immediate-release formulation is approved for use from 1mg up to 16mg. Based on drug company information and Micromedex, the SFVA pharmacy on-line reference resource for drug information, the only contraindication to use of doxazosin is hypersensitivity to doxazosin, its contents, or other quinazolines (e.g. prazosin, terazosin).
PlaceboDrug
Also called Sugar pill
Placebo, or inactive pill.

Study groups in NCT03339258
Study group	Role	What they receive
Doxazosin Mesylate, Extended Release	Experimental	Subjects will undergo a 4-week titration phase during which doxazosin may be increased to a maximum dose of 10mg at bedtime based on symptoms and tolerability. After the 4-week titration phase, subjects will continue at stable dose of study medication for a 4-week stable dose phase. Receives: Drug: Doxazosin Mesylate, Extended Release
Placebo	Placebo comparator	Subjects will undergo a 4-week titration phase during which the placebo may be increased to a maximum dose of 10mg at bedtime based on symptoms and tolerability. After the 4-week titration phase, subjects will continue at stable dose of study placebo for a 4-week stable dose phase. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Clinician Administered PTSD Scale (CAPS) Distressing Dream Score
For the assessment of nightmares, the CAPS developed for the DSM-IV will be utilized. The CAPS IV's wide use as an outcome measure in clinical research has provided abundant information about its reliability and responsiveness to change with treatment in general and for nightmares specifically. All existing studies of alpha-blockers for PTS nightmares and non-nightmare symptoms have used the CAPS for DSM-IV, and therefore our results will be more comparable to existing studies. The distressing dreams item from the CAPS for DSM-IV also has strong behavioral anchors, providing detail on both the frequency and intensity of nightmares. A CAPS (DSM-IV) distressing dreams item score of >=3, as used in prior research on alpha-blockers, will be a requirement for inclusion. Change in CAPS distressing dream score between baseline and end-of-treatment will be the primary measure of the reduction of nightmare frequency/intensity.
Measured: Baseline and Week 9 (end-of-treatment)
Change in Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. Clinical and clinimetric properties of the PSQI were assessed over an 18-month period and acceptable measures of internal homogeneity, consistency (testretest reliability), and validity were obtained. A global PSQI score > 5 yielded a diagnostic sensitivity of 89.6% and specificity of 86.5% (kappa = 0.75, p 0.001) in distinguishing good and poor sleepers. The clinimetric and clinical properties of the PSQI suggest its utility both in psychiatric clinical practice and research activities.
Measured: Weeks 0, 1, 3, 6, 9 (end-of-treatment)
Change in CAPS PTS Symptom Score
Change in total CAPS score, minus the distressing dreams item score
Measured: Baseline and Week 9 (end-of-treatment)

Secondary outcomes (8)

Change in minutes of wake after sleep onset (WASO)
Each morning the subject will record the clock times of their sleep onset and offset, number of nighttime awakenings, wake time in minutes after sleep onset (WASO), number of nightmares and intensity of the worst nightmare on a 10-point scale. They will also rate their sleep quality on a scale from 1-100. From this data, measures of TST, WASO, and SM can be calculated.
Measured: Daily, weeks 0-8
Change in total sleep time (TST)
Each morning the subject will record the clock times of their sleep onset and offset, number of nighttime awakenings, wake time in minutes after sleep onset (WASO), number of nightmares and intensity of the worst nightmare on a 10-point scale. They will also rate their sleep quality on a scale from 1-100. From this data, measures of TST, WASO, and SM can be calculated.
Measured: Daily, weeks 0-8
Change in sleep maintenance (SM)
Each morning the subject will record the clock times of their sleep onset and offset, number of nighttime awakenings, wake time in minutes after sleep onset (WASO), number of nightmares and intensity of the worst nightmare on a 10-point scale. They will also rate their sleep quality on a scale from 1-100. From this data, measures of TST, WASO, and SM can be calculated.
Measured: Daily, weeks 0-8
Nightmare Distress Questionnaire (NDQ)
The NDQ is a self-report assessment of the degree of distress that nightmares cause, and is shown to be a valid, reliable measure of the effects of nightmares.
Measured: Weeks 0, 1, 3, 6, 9 (end-of-treatment)
PTSD Checklist for DSM- 5 (PCL-5)
The PCL-5 will be used as a secondary measure and to assess the internal consistency of the CAPS PTSD symptom score. The PCL-5 is a validated self-report rating scale for assessing PTSD symptoms. It consists of 20 items that correspond to the DSM-5 symptoms of PTSD.
Measured: Weeks 0, 1, 3, 6, 9 (end-of-treatment)
Objective measure of change in TST
The AMI Octagonal Basic Motionlogger (www.ambulatorymonitoring.com), which is worn on the wrist like a watch, is an advanced actigraph which has sufficient memory to record movements for up to 28 days. As indicated by the American Academy of Sleep Medicine Standards of Practice Committee, actigraphy can improve the reliability of self-report estimates of sleep wake timing and may play an important 15 role in the diagnosis and treatment of insomnia. It is also appropriate for the assessment of stability of treatment effects, including the assessment of changes in night-to-night variability in various sleep measures. Our lab has used this actigraph extensively, providing support for its usability in research subjects. High resolution data can be down-sampled for actigraphic sleep-wake estimation.
Measured: All subjects will wear the actigraph daily for 7 days at pre-treatment baseline (week 0), 7 days in week 5 of study drug treatment, and at end-of-treatment week 8 prior to drug discontinuation.
Objective measure of change in WASO
The AMI Octagonal Basic Motionlogger (www.ambulatorymonitoring.com), which is worn on the wrist like a watch, is an advanced actigraph which has sufficient memory to record movements for up to 28 days. As indicated by the American Academy of Sleep Medicine Standards of Practice Committee, actigraphy can improve the reliability of self-report estimates of sleep wake timing and may play an important 15 role in the diagnosis and treatment of insomnia. It is also appropriate for the assessment of stability of treatment effects, including the assessment of changes in night-to-night variability in various sleep measures. Our lab has used this actigraph extensively, providing support for its usability in research subjects. High resolution data can be down-sampled for actigraphic sleep-wake estimation.
Measured: All subjects will wear the actigraph daily for 7 days at pre-treatment baseline (week 0), 7 days in week 5 of study drug treatment, and at end-of-treatment week 8 prior to drug discontinuation.
Objective measures of change in SM
The AMI Octagonal Basic Motionlogger (www.ambulatorymonitoring.com), which is worn on the wrist like a watch, is an advanced actigraph which has sufficient memory to record movements for up to 28 days. As indicated by the American Academy of Sleep Medicine Standards of Practice Committee, actigraphy can improve the reliability of self-report estimates of sleep wake timing and may play an important 15 role in the diagnosis and treatment of insomnia. It is also appropriate for the assessment of stability of treatment effects, including the assessment of changes in night-to-night variability in various sleep measures. Our lab has used this actigraph extensively, providing support for its usability in research subjects. High resolution data can be down-sampled for actigraphic sleep-wake estimation.
Measured: All subjects will wear the actigraph daily for 7 days at pre-treatment baseline (week 0), 7 days in week 5 of study drug treatment, and at end-of-treatment week 8 prior to drug discontinuation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 2018Jun 2024

First posted13 Nov 2017
Study start15 Apr 2018
Primary completionJun 2024 (estimated)
Study completionJun 2024 (estimated)

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: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03339258
Sponsor's protocol ID: W81XWH-17-1-0234
Status last verified: Apr 2024
First submitted: 6 Nov 2017
Last updated: 1 May 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

De Jong J, Wauben P, Huijbrechts I, Oolders H, Haffmans J. Doxazosin treatment for posttraumatic stress disorder. J Clin Psychopharmacol. 2010 Feb;30(1):84-5. doi: 10.1097/JCP.0b013e3181c827ae. No abstract available.
PubMed 20075659
Richards A, Santistevan AC, Yack LM, West AC, Berg E, Pracar S, Batki SL, Seal KH, Neylan TC. A double-blind, randomized, placebo-controlled trial of doxazosin for posttraumatic distressing dreams and sleep disturbance in men and women with posttraumatic stress. J Clin Sleep Med. 2025 Dec 1;21(12):2165-2179. doi: 10.5664/jcsm.11908.
PubMed 41042258

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder

All Stress Disorders, Post-Traumatic trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of Doxazosin for Nightmares, Sleep Disturbance, and Non-Nightmare Clinical Symptoms in Post-Traumatic Stress
ClinicalTrials.gov ID: NCT03339258
Acronym / sponsor ID: W81XWH-17-1-0234
Conditions: Stress Disorders, Post-Traumatic
Keywords: Posttraumatic Stress Disorder, Post-traumatic Stress Disorder, PTSD, Doxazosin, Nightmares, Sleep Disturbance
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 80 participants (estimated)
Lead sponsor: San Francisco Veterans Affairs Medical CenterUS federal agency
Collaborators: United States Department of Defense, Northern California Institute of Research and Education
Study start: 15 Apr 2018 (actual)
Primary completion: Jun 2024 (estimated)
Study completion: Jun 2024 (estimated)
First posted: 13 Nov 2017 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Doxazosin Mesylate, Extended Release	Experimental	Drug: Doxazosin Mesylate, Extended ReleaseSubjects will undergo a 4-week titration phase during which doxazosin may be increased to a maximum dose of 10mg at bedtime based on symptoms and tolerability. After the 4-week titration phase, subjects will continue at stable dose of study medication for a 4-week stable dose phase.
Placebo	Placebo comparator	Drug: PlaceboSubjects will undergo a 4-week titration phase during which the placebo may be increased to a maximum dose of 10mg at bedtime based on symptoms and tolerability. After the 4-week titration phase, subjects will continue at stable dose of study placebo for a 4-week stable dose phase.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

U.S. military veteran or civilian;
age 18-75 and
current full syndromal PTS as indexed by the CAPS-5 (Clinician-administered PTSD scale) or have a current CAPS-5 score ≥ 20, and CAPS-IV recurrent distressing dreams item of ≥ 3; or a CAPS-5 score ≥ 12, and CAPS-IV recurrent distressing dream item of ≥ 4.

Key exclusion criteria (15 listed)

DSM-5 current moderate to severe alcohol or drug use disorder in the last 3 months; moderate alcohol or drug use disorder in the last 3 months will be reviewed on a case-by-case basis;
history of any psychiatric disorder with active psychosis or mania in the past 5 years;
exposure to trauma within the last 3 months;
prominent suicidal or homicidal ideation;
score of 16 or greater AHI based on ApneaLink data analysis in the absence of effective sleep treatment (such as CPAP or oral device)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Doxazosin Mesylate, Extended ReleaseAlso: Cardura XLDoxazosin is FDA-approved for the treatment of hypertension and urinary outflow problems associated with benign prostatic hyperplasia. The immediate-release formulation is approved for use from 1mg up to 16mg. Based on drug company information and Micromedex, the SFVA pharmacy on-line reference resource for drug information, the only contraindication to use of doxazosin is hypersensitivity to doxazosin, its contents, or other quinazolines (e.g. prazosin, terazosin).	Drug	Doxazosin Mesylate, Extended Release
PlaceboAlso: Sugar pillPlacebo, or inactive pill.	Drug	Placebo

Primary outcome

Change in Clinician Administered PTSD Scale (CAPS) Distressing Dream Score
Time frame: Baseline and Week 9 (end-of-treatment)
For the assessment of nightmares, the CAPS developed for the DSM-IV will be utilized. The CAPS IV's wide use as an outcome measure in clinical research has provided abundant information about its reliability and responsiveness to change with treatment in general and for nightmares specifically. All existing studies of alpha-blockers for PTS nightmares and non-nightmare symptoms have used the CAPS for DSM-IV, and therefore our results will be more comparable to existing studies. The distressing dreams item from the CAPS for DSM-IV also has strong behavioral anchors, providing detail on both the frequency and intensity of nightmares. A CAPS (DSM-IV) distressing dreams item score of >=3, as used in prior research on alpha-blockers, will be a requirement for inclusion. Change in CAPS distressing dream score between baseline and end-of-treatment will be the primary measure of the reduction of nightmare frequency/intensity.
Change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: Weeks 0, 1, 3, 6, 9 (end-of-treatment)
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. Clinical and clinimetric properties of the PSQI were assessed over an 18-month period and acceptable measures of internal homogeneity, consistency (testretest reliability), and validity were obtained. A global PSQI score > 5 yielded a diagnostic sensitivity of 89.6% and specificity of 86.5% (kappa = 0.75, p 0.001) in distinguishing good and poor sleepers. The clinimetric and clinical properties of the PSQI suggest its utility both in psychiatric clinical practice and research activities.
Change in CAPS PTS Symptom Score
Time frame: Baseline and Week 9 (end-of-treatment)
Change in total CAPS score, minus the distressing dreams item score

8 secondary outcomes

Change in minutes of wake after sleep onset (WASO)
Time frame: Daily, weeks 0-8
Change in total sleep time (TST)
Time frame: Daily, weeks 0-8
Change in sleep maintenance (SM)
Time frame: Daily, weeks 0-8
Nightmare Distress Questionnaire (NDQ)
Time frame: Weeks 0, 1, 3, 6, 9 (end-of-treatment)
PTSD Checklist for DSM- 5 (PCL-5)
Time frame: Weeks 0, 1, 3, 6, 9 (end-of-treatment)
Objective measure of change in TST
Time frame: All subjects will wear the actigraph daily for 7 days at pre-treatment baseline (week 0), 7 days in week 5 of study drug treatment, and at end-of-treatment week 8 prior to drug discontinuation.
Objective measure of change in WASO
Time frame: All subjects will wear the actigraph daily for 7 days at pre-treatment baseline (week 0), 7 days in week 5 of study drug treatment, and at end-of-treatment week 8 prior to drug discontinuation.
Objective measures of change in SM
Time frame: All subjects will wear the actigraph daily for 7 days at pre-treatment baseline (week 0), 7 days in week 5 of study drug treatment, and at end-of-treatment week 8 prior to drug discontinuation.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
Background: PubMed 20075659De Jong J, Wauben P, Huijbrechts I, Oolders H, Haffmans J. Doxazosin treatment for posttraumatic stress disorder. J Clin Psychopharmacol. 2010 Feb;30(1):84-5. doi: 10.1097/JCP.0b013e3181c827ae. No abstract available.
Derived from this study: PubMed 41042258Richards A, Santistevan AC, Yack LM, West AC, Berg E, Pracar S, Batki SL, Seal KH, Neylan TC. A double-blind, randomized, placebo-controlled trial of doxazosin for posttraumatic distressing dreams and sleep disturbance in men and women with posttraumatic stress. J Clin Sleep Med. 2025 Dec 1;21(12):2165-2179. doi: 10.5664/jcsm.11908.

Related trials for Stress Disorders, Post-Traumatic

Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder

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.

Anne Richards, MD, MPH principal investigator

San Francisco Veterans Affairs Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Doxazosin Mesylate, Extended Release in people with Stress Disorders, Post-Traumatic, run by San Francisco Veterans Affairs Medical Center 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 3 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 1 May 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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.

What does the primary outcome measure?

Change in Clinician Administered PTSD Scale (CAPS) Distressing Dream Score (time frame: Baseline and Week 9 (end-of-treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03339258, 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 1 May 2024.