Ketamine for Combined Depression and Alcohol Use Disorder (KeDA)

This triple-blinded, randomised, active, placebo-controlled trial (n=34) will investigate the effects of ketamine in combination with standard inpatient addiction therapy for adults suffering from depression and alcohol use disorder (AUD).

Depression and alcohol use disorder frequently coexist, posing significant treatment challenges. Ketamine has shown promise in rapidly alleviating depressive symptoms and addressing substance use disorders. This trial aims to assess ketamine’s efficacy and safety in individuals with comorbid depression and alcohol use disorder undergoing standard inpatient addiction therapy.

Adults with at least moderate depression and alcohol use disorder will be enrolled. After screening, participants will undergo baseline assessments, including measures of depression severity, alcohol use, craving, and neurocognitive function. They will then be randomised to receive either ketamine or midazolam (active placebo) alongside standard inpatient addiction therapy.

Follow-up assessments will be conducted post-treatment, with final assessment scheduled six months after baseline. Safety, efficacy, neurocognitive function, alcohol use, and craving will be measured at various time points. The study will also explore changes in alcohol dependence severity, quality of life, treatment effectiveness, and anxiety. Additionally, subjective experiences of treatment will be evaluated using specific inventories.

This intervention involves administering ketamine or midazolam as four single doses biweekly for two weeks. Assessments will include both physician- and self-reported tolerability of treatment sessions, changes in depression severity, and measures of alcohol use disorder.

The study is led by the University Hospital of North Norway and is conducted in collaboration with the University of Exeter. Enrollment is estimated to begin in January 2024, with primary completion anticipated in July 2027. For more information, contact Andreas W Blomkvist, M.D., or Ole K Grønli, Assoc Prof, at University Hospital of North Norway.

Status Not yet recruiting
Results Published No
Start date 01 January 2024
End date 01 July 2027
Phase Phase I Phase II
Design Blinded
Type Interventional
Generation First
Participants 34
Sex All
Age 15- 65
Therapy Yes

Trial Details

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.

NCT Number NCT06090422

Data attribution

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