Recruiting
Phase 2

Ketamine & eCBT

Sponsor:

Queen's University

Code:

NCT04771767

Conditions

Post-Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Ketamine

Online Trauma-Focused Cognitive Behavioural Therapy

Study Details

Brief summary:

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

Conditions

Post-Traumatic Stress Disorder

Study ID

NCT04771767

Start date

Aug 1, 2021

Status verified date

Aug, 2022

Completion date

Mar 31, 2024

Anticipated

Primary completion date

Mar 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

16 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ketamine + eCBT

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

no intervention: Control

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.

Interventions

Ketamine

Patients will receive 6 sub-anesthetic IV ketamine infusions over 8 weeks, each one lasting 40 minutes.

Online Trauma-Focused Cognitive Behavioural Therapy

Participants will enrol in a 12-week online CBT program mirroring in-person trauma-focused CBT.

Primary outcome measure

  • Change in Scores on the Clinician Administered PTSD Scale for DSM-5 [ Time Frame: 0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start ]

Central Contacts and Locations

Central contacts

Aaron E Philipp-Muller, B.Sc.

416-939-316419aepm1@queensu.ca

Locations

Queen's University

Recruiting

Kingston, Ontario, Canada, K7L 3N6

Contacts

Aaron Philipp-Muller, B.Sc.

416939316419aepm1@queensu.ca

More Information

Sponsor

Queen's University

Last update posted

Aug 11, 2022

Last verified

Aug, 2022

Keywords

  • Ketamine
  • Cognitive Behavioral Therapy
  • Online Cognitive Behavioral Therapy
  • Pharmacologically enhanced psychotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Queen's University on 2022-08-11.