Combined Ketamine and eCBT Intervention for PTSD

Queen's University

Status and phase: Enrolling; Phase 2

Conditions: Post-Traumatic Stress Disorder

Treatments: Drug: Ketamine; Behavioral: Online Trauma-Focused Cognitive Behavioural Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04771767

14521759

Details and patient eligibility

About

An open label RCT assessing the efficacy of a combined treatment approach for PTSD, using Ketamine infusions and online Cognitive Behavioural Therapy.

Full description

OBJECTIVES

(i) To introduce a previously untreated patient population with PTSD to new therapeutic options.

(ii) To provide new insights into the functional role of Glutamate in affective disorders as well as in learning and memory.

(iii) To explore the utility of pharmacologically-enhanced psychotherapy.

OUTLINE

The present study is an open label randomized control trial assessing the efficacy of a combined treatment of sub-anaesthetic IV Ketamine in conjunction with online CBT (eCBT). In the study, 16 participants with refractory PTSD will be assigned either to an experimental group receiving a combination of Ketamine and eCBT over 12 weeks, or they will be assigned to a 12-week control group. Both groups will be assessed for symptoms of PTSD and comorbid disorders before treatment, at 2 midway points (4 and 8 weeks), and at the end of the 12 week experimental period. Symptoms of PTSD and comorbid disorders for participants in the experimental group are expected to improve significantly more than participants in the control.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of PTSD by a psychiatrist on the team using the Clinician Administered PTSD Scale (CAPS-5) with a score of at least 50 and a medium presentation.
• Patients will have received at least 2 different types of prior treatment, both of which produced less than a 50% reduction in the participant's symptoms.
• Participants with hypertension or cardiovascular disease must be receiving stable treatment to participate.
• Participants must speak and read English, and will have consistent and reliable access to the internet.
• Patients with suicidal ideation will be included.
• Patients with a history of substance abuse will be included (except for opioid use disorder).

Exclusion criteria

Hypomanic/manic episodes, bipolar disorder, acute psychosis, opioid use disorder, treatment with Naltrexone, pregnancy, postpartum, breastfeeding, untreated hypertension, cardiovascular disease, ASPD, active homicidal ideation, and general noncompliance with the study protocol.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Ketamine + eCBT

Experimental group

Description:

Over 12 weeks, participants receive weekly sessions of asynchronous online cognitive-behavioural therapy as well as 6 sub-anesthetic infusions of Ketamine

Treatment:

Behavioral: Online Trauma-Focused Cognitive Behavioural Therapy

Drug: Ketamine

Control

No Intervention group

Description:

Participants are in a control condition receiving treatment as usual, during which time they will not receive the experimental treatment and will have no change in their treatment regimen.