Ketamine-enhanced Prolonged Exposure Therapy in PTSD
Purpose
The purpose of this study is to test the safety and efficacy of repeated doses of ketamine as compared to placebo to reduce symptoms of Posttraumatic Stress Disorder (PTSD) among Veteran receiving Prolonged Exposure Therapy.
Condition
- PTSD
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- male or female Veterans between the ages of 18 and 75 years - diagnosis of PTSD - ability to provide written informed consent
Exclusion Criteria
- females who are currently pregnant or breastfeeding - current high risk for suicide - history of moderate/severe head injury - history of psychosis - current episode of mania/hypomania - severe substance and/or alcohol use disorder in the last 6 months
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Subjects will be randomly assigned to one of two parallel treatment conditions: 1) adjunctive ketamine infusions to prolonged exposure therapy or 2) adjunctive midazolam (active placebo) infusions to prolonged exposure therapy.
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- The investigators will use a sequentially numbered, opaque, sealed envelopes, pharmacy-controlled allocations, and coded identical containers for adequate concealment allocation. Administration of study drugs and infusion monitoring will be conducted by research nurse keeping blinding from investigators and independent outcome assessors.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Ketamine and prolonged exposure (PE) |
Single IV ketamine 0.5 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions. |
|
|
Placebo Comparator Midazolam and prolonged exposure (PE) |
Single IV midazolam 0.045 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- VA Office of Research and Development
Detailed Description
In this single site clinical trial, intended to evaluate the safety and efficacy of repeated doses of ketamine in conjunction with prolonged exposure (PE) therapy for PTSD. Veterans who meet criteria for PTSD and the additional inclusion and exclusion criteria will be randomized to one of two treatment arms (placebo plus PE vs ketamine plus PE). Participants receive the study drug via intravenous infusion once per week for 3-weeks.
