Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03960658 |
| Other study ID # |
VAM-18-00333 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 1/Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
April 3, 2019 |
| Est. completion date |
December 4, 2019 |
Study information
| Verified date |
March 2021 |
| Source |
Minneapolis Veterans Affairs Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study aims at investigating the effectiveness of the drug, Ketamine, in combination with
Prolonged Exposure (PE) therapy for people suffering from PTSD. Participation in the study
includes Ketamine infusions, which occur once a week for three weeks. PE therapy sessions
will be scheduled one day after each infusion, and may continue up to 12 weeks. After
completely therapy, there will be two monthly follow-up assessment visits.
Description:
Study location: Minneapolis VA Medical Center
The study is an open-label interventional study designed to inform and strengthen the
feasibility of protocol implementation on sub-anesthetic doses of intravenous Ketamine as
augmenting strategy of standardized, manually-driven Prolonged Exposure therapy in PTSD.
Timeline: Eligible individuals can expect their participation to last up to 5 months.
Compensation will be given for participation per session that is attended. Potential
participants will be provided with information about the study and asked a series of
questions to determine if they meet basic inclusion/exclusion criteria (e.g., indicators of
current PTSD). They will be informed that the treatment involves multiple infusions of
sedatives at subanesthetic doses followed by PE therapy. Those interested will be scheduled
for an in-person, baseline session.
Voluntary informed consent will be obtained in accordance with local IRB approvals. During
the baseline, all assessments, computer tasks, and information on treatment will be
explained. Participants will also undergo a urine toxicology analysis during this session.
Ketamine infusions and PE therapy appointments will be scheduled within two weeks of the
baseline.
The day of the infusion, patients will arrive in the morning after an overnight fast of at
least 8 hours. An IV will be placed in the non-dominant arm for medication administration.
Vitals will be recorded throughout the entire medication treatment. Subjects will then
receive IV infusion of 0.5mg/Kg of ketamine hydrochloride solution over 40 minutes. The dose
of ketamine will be calculated by ideal body weight. Any altered sensory or dissociative
effects will be measured before and after each infusion. Vitals will be monitored for another
hour, until all side-effects have subsided. Participants are required not to drive or use
heavy machinery until the following morning.
One day after the infusion, patients will come back for study assessments and Prolonged
Exposure therapy with a VA psychologist. PE is an evidence-based psychotherapy for PTSD that
is based on the Emotional Processing Theory of PTSD; the four components of PE are: 1)
exposure to safe situations, objects, or people that cause distress and are avoided because
they are trauma reminders (in vivo exposure), 2) revisiting and processing of the trauma
memory (imaginal exposure), 3) psycho-education about trauma-related symptoms, and 4)
breathing retraining. Session 1 includes the presentation of treatment rationale and program
overview, information gathering, and breathing retraining. Session 2 includes education about
common reactions to trauma, rationale for in vivo exposure, and construction of an in vivo
exposure hierarchy. The hierarchy includes safe or low-risk activities and situations that
were avoided because of their association with the trauma. Throughout the treatment,
participants will be assigned homework to confront items on the hierarchy in a gradual
fashion, working up to the most anxiety-arousing situations. During Session 3, the rationale
for confronting the trauma memory in imagination is presented and initiation of imaginal
exposure and processing is conducted. In this procedure, participants will be asked to close
their eyes, visualize the trauma, and recount it aloud in the present tense for 45-60 min.
The memory recounting will be repeated if necessary to allow total reliving of 45-60 min. The
exposure will be audiotaped; participants will be instructed to listen daily to the tape.
Sessions 4-10 will be conducted in a similar fashion: therapists review homework, conduct
imaginal exposure to trauma memory for 30-45 min, discuss the imaginal exposure, and assigned
in vivo and imaginal exposure homework. In the final session, participants summarize learning
in treatment, discuss their progress, plans, and relapse prevention.
Upon PE completion, participants are asked to come back for 2 follow-up sessions over two
months. Familiar study and PTSD assessments will be administered during this time.
