Ketamine for Combined Depression and Alcohol Use Disorder

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity Hospital of North Norway

About this trial

The goal of this clinical trial is to investigate the effects of ketamine, in combination with standard inpatient addiction therapy, for adults with depression and alcohol use disorder. After screening and enrollment, participants will undergo baseline assessments of depression, measures of alcohol use and craving, as well as neurocognitive function. Participants will then be randomized to either ketamine (intervention) or midazolam (control). All participants will be admitted for standard inpatient addiction therapy while receiving ketamine or midazolam. Measures on safety, depression and alcohol use disorder will be repeatedly assessed during and after treatment. Final follow-up assessment is scheduled 6 months after baseline assessment.

Eligibility criteria

Qualifiers

None

Disqualifiers

Currently abstinent from alcohol

At least moderate depression without psychotic features

Minimum Montgomery-Åsberg Depression Rating Scale (MADRS) of 20

Alcohol dependence

Trial design

Treatments tested in this trial

  • Ketamine Hydrochloride
  • Midazolam Hydrochloride

Treatment groups

34 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital of North Norway

Lead sponsor

University of Exeter

Collaborator