CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Yohimbine +1 moredrug
Likely dose
Not stated in record
Key inclusion· 4
  • Male veterans and post-deployed active duty personnel of OEF/OIF
  • Age 18–45 years
  • DSM-IV PTSD diagnosis confirmed on CAPS
  • If taking SSRIs, must be stabilized on current dose for at least 14 days prior to trial
Key exclusion· 7
  • Psychiatric hospitalization or suicide attempt within 2 months
  • Schizophrenia or other serious mental illness besides PTSD
  • Active drug dependence (but alcohol use disorder allowed if no withdrawal symptoms)
  • Panic disorder (yohimbine may precipitate panic attacks)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01031979
NCT01031979Phase 2Completed

Psychophysiology of Prolonged Exposure for PTSD With/Without Yohimbine

VA Office of Research and Development·interventional·Posted Dec 15, 2009·Updated Feb 7, 2018

In Brief

A Phase 2 clinical trial evaluating Yohimbine and Placebo for Post-Traumatic Stress Disorder. Completed, enrolled 26 participants across 1 site.

Detailed Summary

The proposed study has three distinct but related research objectives. The first goal is to measure physiological correlates of successful treatment with Prolonged Exposure (PE) therapy for posttraumatic stress disorder (PTSD) in veterans of the Iraq and Afghanistan wars. Individuals with PTSD often experience elevated heart rates and other objectively measurable signs of anxiety when confronted with safe situations that remind them of past dangerous situations. We will measure physiological responses and compare the outcomes to patient's self reported subjective accounts of symptom improvement on traditional measures of PTSD. Developing a way to measure objective gains in symptoms improvement may help researchers who are studying ways to improve PTSD treatment. The second goal of the study is to investigate if yohimbine, a drug found to promote a specific type of learning, will improve treatment outcomes for veterans in PTSD treatment. The third goal is to investigate if ability to get used to loud startling audio tones correlates to baseline PTSD pathology and treatment outcomes for PE. This goal represents an important step forward in understanding characteristics of heritable traits that are related PTSD. It is significant because such research may one day lead to the development of individual responder policies that will assist patients by individualizing treatment plans based on personal characteristics.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 15, 2009
Enrollment StartDec 1, 2010
Primary CompletionApr 1, 2015
Study CompletionJul 7, 2015
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 16.5 years ago

Interventions

Yohimbinedrug

alpha-2 adrenergic receptor antagonist

Placebodrug

Placebo