Ignite Creation Date:
2024-05-05 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 9:47 AM
Study NCT ID:
NCT00645450
Status:
TERMINATED
Last Update Posted:
2019-07-02
First Post:
2008-03-19
Brief Title:
PTSD Symptom Reduction by Propranolol Given After Trauma Memory Activation
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
PTSD Symptom Reduction by Propranolol Given After Memory Activation
Status:
TERMINATED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty recruiting subjects and loss of study physician for new job
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a randomized double-blind placebo-controlled clinical trial of propranolol combined with trauma memory reactivation to determination if this approach is effective in treating PTSD symptoms Participants will include male and female combat Veterans of the Afghanistan and Iraqi wars meeting DSM-IV criteria for chronic PTSD recruited locally from the Manchester VAMC Mental Hygiene Clinic or through advertising The presence of PTSD will be assessed using the CAPS Participants will be randomly assigned to the propranolol or placebo drug condition During each of six memory reactivation sessions the participant will meet with a psychiatrist who will ask the participant to spend ten minutes describing the event that caused their PTSD and their reactions to it The interviewer will facilitate this process by asking questions keeping the participant focused on the traumatic event and encouraging himher to identify aspects of the traumatic event that continue to provoke emotional distress The traumatic memory reactivation will be immediately followed by administration of propranolol or placebo Following the six treatment sessions script-driven imagery will be used to assess HR SC and facial EMG responses to recollections of the traumatic event and PTSD symptoms will be assessed using the CAPS A previously developed discriminant function will be used to classify each person as a physiologic responder or non-responder There will also be a 6-month follow-up assessment
Detailed Description:
OBJECTIVE In the first of two preliminary studies the investigators demonstrated in individuals with chronic PTSD that a single combined 40 mg short- and 60 mg long-acting 24-hour oral dose of propranolol compared to placebo given immediately following reactivation of the PTSD-related memory of the traumatic event significantly reduced physiological responses during script-driven imagery of that event measured one week later These results support blockade of reconsolidation of the traumatic memory a process that is entirely distinct from extinction In addition the investigators found a trend for post-reactivation propranolol to reduce self-reported PTSD symptoms measured via the Impact of Event Scale-Revised IES-R In the second preliminary study the investigators performed 6 weekly treatments that consisted of the subject describing their PTSD-related traumatic events for approximately 10 minutes followed by 067 mgkg minimum 40 mg short-acting propranolol plus 1 mgkg minimum 60 mg long-acting propranolol The mean Clinician Administered PTSD Scale CAPS Total Score following the six treatment sessions was reduced by 44 p02 The proposed work will examine whether repeated treatments may succeed in producing more substantive symptomatic improvement
RESEARCH PLAN The study design will be a randomized double-blind placebo-controlled clinical trial A crossover design is not being proposed because the effect is expected to be neither short-term nor reversible Rather at the conclusion of the formal study period individuals randomized to the placebo condition will be offered an equal number of treatment sessions with propranolol A placebo control will be used rather than an active treatment control because the proposed study will be a proof of concept test of post-reactivation pharmacological reduction of traumatic memories The control and active treatments will be structured so as to minimize the chance of extinction The investigators recognize that eventually this new treatment will need to be tested against established PTSD treatments including exposure if its clinical utility is to be established The investigators regard this as a matter for subsequent studies should the present study yield promising results However the investigators do intend to compare the effect size the investigators find for the proposed intervention with published effect sizes for other PTSD psychotherapies
METHODOLOGY Participants will include male and female combat Veterans of the Afghanistan and Iraqi wars meeting DSM-IV criteria for chronic PTSD recruited locally from the Manchester VAMC Mental Hygiene Clinic or through advertising The presence of PTSD will be assessed using the CAPS Participants will be randomly assigned to the propranolol or placebo drug condition During each of six memory reactivation sessions the participant will meet with a psychiatrist who will ask the participant to spend ten minutes describing the event that caused their PTSD and their reactions to it The interviewer will facilitate this process by asking questions keeping the participant focused on the traumatic event and encouraging himher to identify aspects of the traumatic event that continue to provoke emotional distress The traumatic memory reactivation will be immediately followed by administration of propranolol or placebo Following the six treatment sessions script-driven imagery will be used to assess HR SC and facial EMG responses to recollections of the traumatic event and PTSD symptoms will be assessed using the CAPS A previously developed discriminant function will be used to classify each person as a physiologic responder or non-responder There will also be a 6-month follow-up assessment
CLINICAL RELEVANCE The mechanism of memory reconsolidation offers the possibility that cellular plasticity can be capitalized on to reverse the neuroanatomical and neurophysiological underpinnings of traumatic memories The possibility that a traumatic memory could be significantly weakened by an intervention as simple as the post-reactivation administration of a widely used and safe medication has profound implications for the treatment of PTSD
RESEARCH PLAN The study design will be a randomized double-blind placebo-controlled clinical trial A crossover design is not being proposed because the effect is expected to be neither short-term nor reversible Rather at the conclusion of the formal study period individuals randomized to the placebo condition will be offered an equal number of treatment sessions with propranolol A placebo control will be used rather than an active treatment control because the proposed study will be a proof of concept test of post-reactivation pharmacological reduction of traumatic memories The control and active treatments will be structured so as to minimize the chance of extinction The investigators recognize that eventually this new treatment will need to be tested against established PTSD treatments including exposure if its clinical utility is to be established The investigators regard this as a matter for subsequent studies should the present study yield promising results However the investigators do intend to compare the effect size the investigators find for the proposed intervention with published effect sizes for other PTSD psychotherapies
METHODOLOGY Participants will include male and female combat Veterans of the Afghanistan and Iraqi wars meeting DSM-IV criteria for chronic PTSD recruited locally from the Manchester VAMC Mental Hygiene Clinic or through advertising The presence of PTSD will be assessed using the CAPS Participants will be randomly assigned to the propranolol or placebo drug condition During each of six memory reactivation sessions the participant will meet with a psychiatrist who will ask the participant to spend ten minutes describing the event that caused their PTSD and their reactions to it The interviewer will facilitate this process by asking questions keeping the participant focused on the traumatic event and encouraging himher to identify aspects of the traumatic event that continue to provoke emotional distress The traumatic memory reactivation will be immediately followed by administration of propranolol or placebo Following the six treatment sessions script-driven imagery will be used to assess HR SC and facial EMG responses to recollections of the traumatic event and PTSD symptoms will be assessed using the CAPS A previously developed discriminant function will be used to classify each person as a physiologic responder or non-responder There will also be a 6-month follow-up assessment
CLINICAL RELEVANCE The mechanism of memory reconsolidation offers the possibility that cellular plasticity can be capitalized on to reverse the neuroanatomical and neurophysiological underpinnings of traumatic memories The possibility that a traumatic memory could be significantly weakened by an intervention as simple as the post-reactivation administration of a widely used and safe medication has profound implications for the treatment of PTSD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None