Reducing Reconsolidation of Trauma Memories With Propranolol
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Douglas Mental Health University Institute.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Douglas Mental Health University Institute
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
Douglas Mental Health University Institute
ClinicalTrials.gov Identifier:
NCT01349439
First received: March 31, 2011
Last updated: May 5, 2011
Last verified: March 2011
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Purpose
The purpose of this study is to test whether propranolol is capable of reducing subsequent physiological trauma-related conditioned responses, as well as self-reported post-traumatic stress disorder (PTSD) symptoms.
| Condition | Intervention | Phase |
|---|---|---|
|
Posttraumatic Stress Disorder |
Drug: Propranolol Drug: Short acting + long acting propranolol + memory reactivation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Reduction of the Reconsolidation of the Trauma Memory With Propranolol |
Resource links provided by NLM:
Further study details as provided by Douglas Mental Health University Institute:
Primary Outcome Measures:
- Electromyogram [ Time Frame: Two weeks post-treatment ] [ Designated as safety issue: No ]
- Heart rate [ Time Frame: Two weeks post-treatment ] [ Designated as safety issue: No ]
- Skin conductance [ Time Frame: Two weeks post-treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- PTSD symptom levels [ Time Frame: 2 to 26 weeks ] [ Designated as safety issue: No ]PTSD symptom levels will be assessed 2 to 26 weeks after randomization
- Quality of life [ Time Frame: 2 to 26 weeks ] [ Designated as safety issue: No ]Quality of life assessments will be conducted 2 to 26 weeks following randomization
- Memory Experience [ Time Frame: 2 to 26 weeks ] [ Designated as safety issue: No ]The Memory Experiences Questionnaire will be administered from 2 to 26 weeks following randomization
- Psychophysiological assessments [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Psychophysiological assessments will be repeated 26 weeks following randomization
| Estimated Enrollment: | 76 |
| Study Start Date: | March 2011 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Propranolol + Memory Reactivation
This arm involves recalling the traumatic event after administration of propranolol
|
Drug: Propranolol
1mg per Kg (participant weight)
|
|
Experimental: Placebo + Memory reactivation
This arm involves recalling the traumatic event after administration of a placebo
|
Drug: Propranolol
1mg per Kg (participant weight)
|
|
Experimental: Placebo + No Memory Reactivation
This arm involves administration of a placebo without recalling the traumatic event
|
Drug: Propranolol
1mg per Kg (participant weight)
|
|
Experimental: Propranolol + No Memory Reactivation
This arm involves administration of propranolol without recalling the traumatic event
|
Drug: Propranolol
1mg per Kg (participant weight)
|
|
Open-label Propranolol + Memory Reactivation
All participants terminating the double-blind phase of the study will receive open-label reconsolidation blockade treatment with propranolol combined with recall of the traumatic event for six weeks.
|
Drug: Short acting + long acting propranolol + memory reactivation
After completing the double-blind phase of the study, participants will receive short acting propranolol 1mg/kg (patient weight) + long acting propranolol (1 or 1.5 mg/kg) followed by memory reactivation. Dose level for the long-acting propranolol will be randomly assigned across participants.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Suffer from chronic PTSD for at least 6 consecutive months;
- Obtain a score of 33 or more on the Impact of Events Scale-Revised:
- For participants aged 40 years: accept to undergo an electrocardiogram assessment. The results of the electrocardiogram must be normal;
- Accept to not commence taking new medications on a regular basis during the study.
Exclusion Criteria:
- Hypotension;
- Cardiac rhythm below 55 beats per minute;
- Medical conditions that contraindicates the administration of propranolol;
- Previous adverse reaction to, or non-compliance with, beta-blockers;
- Current use of medication that may involve potentially dangerous interactions with propranolol;
- Any medication that can have an impact on cardiac rhythm;
- Women who are breast feeding;
- Past or present bipolar disorder or psychosis,
- Present substance abuse or dependence, suicidal ideation;
- Participating in psychotherapy other than support psychotherapy;
- An average score above 20 on the Dissociative Experience Scale.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349439
Contacts
| Contact: Alain R Brunet, Ph.D. | 514-761-6131 ext 4348 | alain.brunet@mcgill.ca |
Locations
| Canada, Quebec | |
| Douglas Mental Health University Institute | Recruiting |
| Verdun, Quebec, Canada, H4H 1R3 | |
| Contact: Andrea Ashbaugh, Ph.D. 514-761-6131 ext 4341 andrea.ashbaugh@douglas.mcgill.ca | |
| Principal Investigator: Alain Brunet, Ph.D. | |
Sponsors and Collaborators
Douglas Mental Health University Institute
Canadian Institutes of Health Research (CIHR)
Investigators
| Principal Investigator: | Alain Brunet, Ph.D. | Douglas Institute Research Centre |
More Information
Additional Information:
Publications:
| Responsible Party: | Alain Brunet, Douglas Mental Health University Institute |
| ClinicalTrials.gov Identifier: | NCT01349439 History of Changes |
| Other Study ID Numbers: | 08-44 |
| Study First Received: | March 31, 2011 |
| Last Updated: | May 5, 2011 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders Propranolol Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
Antihypertensive Agents Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Vasodilator Agents |
ClinicalTrials.gov processed this record on May 23, 2013