Posttraumatic Stress DisordersPhase 2NCT00611871
The Use of Propranolol to Block Memory Reconsolidation in PTSD
A Phase 2 study testing Propranolol in people with Posttraumatic Stress Disorders, run by Wayne State University at 1 site in United States.
Trial summary
The purpose of this investigation is to see if propranolol will reduce the psychophysiological hyperactivation associated with memories of combat stress in Veterans with Posttraumatic Stress Disorder. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Posttraumatic Stress Disorders
- What is being tested?
- Propranolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Sep 2015
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Participants will meet the clinical criteria of PTSD (DSM IVTR) secondary to combat exposure.
Who cannot join
- Current illicit substance use or alcohol consumption, as determined by urine toxicology and alcohol breath test.
- Any diagnosis of current comorbid psychotic disorders, bipolar disorder, or illicit substance or alcohol abuse or dependence.
- Any current prescription medication usage or supplement (dietary or herbal) usage that is contraindicated with propranolol.
- Active enrollment into any psychiatric or psychological treatment.
- Any condition that contraindicates the use of propranolol, such as:
- history of bronchial asthma.
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- heart block.
- sinus bradycardia.
- congestive heart failure.
- insulin-dependent diabetes.
- initial systolic blood pressure < 100 mmHg.
- Hyperthyroidism.
- Thyroid disease.
- Renal or liver impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Propranolol to Block Memory Reconsolidation in Post Traumatic Stress Disorders (PTSD)
The purpose of this investigation is to see if propranolol will reduce the psychophysiological hyperactivation associated with memories of combat stress in Veterans with Posttraumatic Stress Disorder.
Read the detailed description
The goal of this translational research project is to generate a pilot sample of data from an investigation of a novel therapeutic approach to post traumatic stress disorder (PTSD). Current treatments for PTSD include exposure and other aspects of cognitive therapy as well as drug therapies based on serotonin-reuptake inhibiting antidepressant agents. However, these treatments are often unsuccessful, and symptoms in affected individuals may persist for decades. The central hypothesis guiding this research project posits that acquired fear responses, such as those in PTSD, when reactivated by recall become sensitive to noradrenergic modulation and thus may be permanently attenuated by blocking noradrenergic transmission. Further, we predict that this attenuation will facilitate subsequent therapy. In the current study, we will be investigating this model in three groups of Veterans of either Operation Iraqi Freedom or Operation Enduring Freedom (OIF/OEF) with PTSD: 1) Individuals who receive propranolol following recall of a traumatic memory (Propranolol-trauma); 2) Individuals who receive a placebo following recall of a traumatic memory (Placebo-trauma), and; 3) Individuals who receive propranolol following recall of an affective neutral memory (Propranolol-neutral). In addition, traumatic memory recall will be psychophysiologically assessed by measuring Veterans' facial corrugator electromyography (EMG), skin conductance, blood pressure and cardiovascular inter-beat interval responses pre- and one month post-medication administration.
- Conditions
- Posttraumatic Stress Disorders
- Being tested
- Propranolol, Placebo
- 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.
PropranololDrug
40mg propranolol, followed 2 hrs after with 60mg propranolol, immediately following memory recollection
PlaceboDrug
40mg placebo, followed 2 hrs after with 60mg placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Propranolol following traumatic memory Receives: Drug: Propranolol |
| 2 | Active comparator | Propranolol following neutral memory Receives: Drug: Propranolol |
| 3 | Placebo comparator | Placebo following traumatic memory Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial corrugator EMG
Measured: Change in Facial corrugator EMG from baseline at 1 month post-intervention
Secondary outcomes (2)
CAPS score
Measured: Change in CAPS score from baseline at 1 month post-intervention
PCL-M score
Measured: Change in PCL-M score from baseline at 1 month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startSep 2007
- Primary completionAug 2015
- Study completionSep 2015
Why it stopped: Low enrollment, grant term expired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisordersStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- John D. Dingell VA Medical Center, New York University
- Responsible party
- Principal investigator, Deane Aikins, Wayne State University
- Investigators
- Deane Aikins, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611871
- Sponsor's protocol ID
- HIC 0703002443
- Status last verified
- Oct 2016
- First submitted
- 1 Jan 2008
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Propranolol to Block Memory Reconsolidation in Post Traumatic Stress Disorders (PTSD)
- ClinicalTrials.gov ID
- NCT00611871
- Acronym / sponsor ID
- HIC 0703002443
- Conditions
- Posttraumatic Stress Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment, grant term expired
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- John D. Dingell VA Medical Center, New York University
- Study start
- Sep 2007
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 11 Feb 2008 (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.
The purpose of this investigation is to see if propranolol will reduce the psychophysiological hyperactivation associated with memories of combat stress in Veterans with Posttraumatic Stress Disorder.
Detailed description
The goal of this translational research project is to generate a pilot sample of data from an investigation of a novel therapeutic approach to post traumatic stress disorder (PTSD). Current treatments for PTSD include exposure and other aspects of cognitive therapy as well as drug therapies based on serotonin-reuptake inhibiting antidepressant agents. However, these treatments are often unsuccessful, and symptoms in affected individuals may persist for decades. The central hypothesis guiding this research project posits that acquired fear responses, such as those in PTSD, when reactivated by recall become sensitive to noradrenergic modulation and thus may be permanently attenuated by blocking noradrenergic transmission. Further, we predict that this attenuation will facilitate subsequent therapy. In the current study, we will be investigating this model in three groups of Veterans of either Operation Iraqi Freedom or Operation Enduring Freedom (OIF/OEF) with PTSD: 1) Individuals who receive propranolol following recall of a traumatic memory (Propranolol-trauma); 2) Individuals who receive a placebo following recall of a traumatic memory (Placebo-trauma), and; 3) Individuals who receive propranolol following recall of an affective neutral memory (Propranolol-neutral). In addition, traumatic memory recall will be psychophysiologically assessed by measuring Veterans' facial corrugator electromyography (EMG), skin conductance, blood pressure and cardiovascular inter-beat interval responses pre- and one month post-medication administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PropranololPropranolol following traumatic memory |
| 2 | Active comparator | Drug: PropranololPropranolol following neutral memory |
| 3 | Placebo comparator | Drug: PlaceboPlacebo following traumatic memory |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants will meet the clinical criteria of PTSD (DSM IVTR) secondary to combat exposure.
Key exclusion criteria (14 listed)
- Current illicit substance use or alcohol consumption, as determined by urine toxicology and alcohol breath test.
- Any diagnosis of current comorbid psychotic disorders, bipolar disorder, or illicit substance or alcohol abuse or dependence.
- Any current prescription medication usage or supplement (dietary or herbal) usage that is contraindicated with propranolol.
- Active enrollment into any psychiatric or psychological treatment.
- Any condition that contraindicates the use of propranolol, such as:
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 |
|---|---|---|
| Propranolol40mg propranolol, followed 2 hrs after with 60mg propranolol, immediately following memory recollection | Drug | 1, 2 |
| Placebo40mg placebo, followed 2 hrs after with 60mg placebo | Drug | 3 |
Primary outcome
Facial corrugator EMG
Time frame: Change in Facial corrugator EMG from baseline at 1 month post-intervention
2 secondary outcomes
CAPS score
Time frame: Change in CAPS score from baseline at 1 month post-intervention
PCL-M score
Time frame: Change in PCL-M score from baseline at 1 month post-intervention
Results and safety
The study was stopped early (reason given: Low enrollment, grant term expired). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Individual participant dataSharing planned: No
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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.
Deane Aikins, PhD principal investigator
Wayne State University
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 Propranolol in people with Posttraumatic Stress Disorders, run by Wayne State University 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 1 inclusion and 14 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: stopped early, as of the sponsor's last update on 1 Nov 2016. 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?
The study was stopped early (reason given: Low enrollment, grant term expired). 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?
Facial corrugator EMG (time frame: Change in Facial corrugator EMG from baseline at 1 month post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2016.