Clinical TrialPTSDKetamineUnknown status

Combined Ketamine and eCBT Intervention for PTSD

Open-label, non-randomised parallel-group study (n=16) testing six sub-anaesthetic IV ketamine infusions plus 12-week online CBT versus treatment as usual in participants with refractory PTSD.

Target Enrollment
16 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Open-label, non-randomised parallel-group study comparing six sub-anaesthetic IV ketamine infusions combined with a 12-week asynchronous online trauma-focused CBT programme against treatment as usual in participants with refractory PTSD; assessments at baseline, 4, 8 and 12 weeks.

Primary aims are to evaluate clinical efficacy of the combined intervention, explore glutamatergic mechanisms in affective disorders, and assess the utility of pharmacologically-enhanced psychotherapy.

Study Protocol

Preparation

sessions

Dosing

6 sessions
40 min each

Integration

sessions

Therapeutic Protocol

cbt

Study Arms & Interventions

Ketamine + eCBT

experimental

Six sub-anaesthetic IV ketamine infusions plus a 12-week online trauma-focused CBT programme.

Interventions

  • Ketamine
    via IV• six infusions over 8 weeks• 6 doses total

    Sub-anaesthetic IV infusions; each infusion ~40 minutes.

  • Compound
    via Other• 12-week programme• 12 doses total

    Asynchronous online trauma-focused CBT (TF-CBT).

Control

waitlist

Treatment as usual for 12 weeks; no change in treatment regimen.

Interventions

  • Compound
    • treatment as usual

    Participants continue usual care and do not receive the experimental interventions during the 12-week period.

Participants

Ages
18 – 65
Sexes
Male & Female

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.

Study Details

  • Status
    Unknown status
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment16 participants
  • Timeline
    Start: 2021-08-01
    End: 2024-03-31
  • Compound
    Ketamine
  • Topic
    PTSD

Study Team

Sponsors & Collaborators

Locations

Queen's University — Kingston, Ontario, Canada

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Combined Ketamine and eCBT Intervention for PTSD — Clinical Trial Details | Blossom