Ignite Creation Date:
2024-05-06 @ 3:06 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04523922
Status:
RECRUITING
Last Update Posted:
2024-01-08
First Post:
2020-08-19
Brief Title:
Oxytocin to Enhance Integrated Treatment for AUD and PTSD
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Oxytocin to Enhance Integrated Exposure-Based Treatment of Co-occurring Alcohol Use Disorder and PTSD
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPEOT
Brief Summary:
The primary objective of the proposed Stage II study is to examine the efficacy of oxytocin OT as compared to placebo in reducing 1 alcohol use disorder AUD symptoms and 2 post-traumatic stress disorder PTSD symptoms among Veterans receiving COPE therapy Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure To evaluate purported neurobiological mechanisms of change we will employ functional magnetic resonance imaging fMRI at pre- and post-treatment
Detailed Description:
Alcohol use disorder AUD and posttraumatic stress disorder PTSD frequently co-occur and are associated with significant morbidity mortality and health care expenditures Military Veterans are at increased risk for co-occurring AUD and PTSD with prevalence rates 2-4 times higher than the general population Our group developed an integrated intervention entitled Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure COPE COPE incorporates empirically validated cognitive-behavioral techniques for AUD with Prolonged Exposure PE therapy for PTSD Several randomized controlled trials among Veterans and civilians demonstrate efficacy of COPE in significantly reducing AUD and PTSD symptoms Despite the positive findings there remains substantial room for improving treatment outcomes and enhancing retention Accumulating data suggest that the neuropeptide oxytocin OT is a promising candidate to enhance psychosocial interventions for co-occurring AUD and PTSD as OT targets neurobiological and behavioral dysregulation common to both disorders Preclinical and clinical studies demonstrate the ability of OT to ameliorate a variety of alcohol-related behaviors eg craving withdrawal symptoms tolerance ethanol self-administration enhance fear extinction and promote prosocial behaviors associated with successful psychosocial treatment outcomes In a randomized controlled pilot study our group found that OT administration prior to weekly Prolonged Exposure PE therapy sessions was safe well-tolerated and resulted in accelerated reduction in PTSD symptoms as compared to placebo Although the empirical and theoretical support for augmenting psychosocial interventions such as COPE with OT is robust no studies to date have examined this combined approach The primary objective of the proposed Stage II study is to examine the efficacy of OT as compared to placebo in reducing 1 AUD symptoms and 2 PTSD symptoms among Veterans 50 women receiving COPE therapy To accomplish this we will employ a manualized evidence-based cognitive-behavioral intervention COPE a randomized double-blind placebo-controlled study design and standardized repeated dependent measures of clinical outcomes at multiple time points In addition to investigate neurobiological mechanisms of change we will employ functional magnetic resonance imaging fMRI at pre-and post-treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None