Ketamine for Combined Depression and Alcohol Use Disorder

NCT06090422 | Not Yet Recruiting Phase 1 DMC

• 3 other identifiers: 2022/484848(REK)2023-506052-24U1111-1293-2654
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Depression; Alcohol Use Disorder

Keywords

Depression; Alcohol use disorder; Ketamine; Addiction

Outcome Measures

Primary Outcomes (1)

• Depression

  Change from baseline using rater-blinded Montgomery-Åsberg Depression Rating Scale (MADRS) (range 0-60; higher score indicate worse outcome)

  Within 3 days after final treatment session

Secondary Outcomes (5)

• Alcohol craving tonic

  Repeated measurements from baseline and 1 day, 1 week, 2 weeks and 4 weeks after final treatment session

• Alcohol craving phasic

  Repeated measurements from baseline and 1 day, 1 week, 2 weeks and 4 weeks after final treatment session

• Depression response/remission

  Repeated measurements from baseline and 1 day, 1 week, 2 weeks and 4 weeks after final treatment session

• Relapse risk

  From baseline until 6 months after baseline

• Time until relapse

  From baseline until 3 and 6 months after baseline

Other Outcomes (7)

• Duration of antidepressant effect (blinded-rater assessed)

  From baseline until 6 months after baseline

• Duration of antidepressant effect (self-report)

  From baseline until 6 months after baseline

• Tolerability using the ketamine side effect tool (KSET)

  Up to 1 month

Study Arms (2)

Intervention group

EXPERIMENTAL

Ketamine, 0,8 mg/kg body weight, given as four single doses (biweekly for two weeks)

Drug: Ketamine Hydrochloride

Control group

ACTIVE COMPARATOR

Midazolam, 0,8 mg/kg body weight, given as four single doses (biweekly for two weeks)

Drug: Midazolam Hydrochloride

Interventions

Ketamine Hydrochloride DRUG

Four single-doses, given two times per week for two weeks Dose: 0,8 mg/kg body weight Route of administration: intravenous infusions over 40 minutes

Intervention group

Midazolam Hydrochloride DRUG

Four single-doses, given two times per week for two weeks Dose: 0,02 mg/kg body weight Route of administration: intravenous infusions over 40 minutes

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Currently abstinent from alcohol
• At least moderate depression without psychotic features
• Minimum Montgomery-Åsberg Depression Rating Scale (MADRS) of 20
• Alcohol dependence
• Admitted for inpatient addiction therapy at University Hospital of North Norway
• Intoxicated or in significant withdrawal from alcohol or drug use
• Not able to give adequate informed consent
• Current or past history of schizophrenia, schizophreniform disorder, paranoid delusional disorder, schizoaffective disorder
• Current or historical diagnosis of schizophrenia in a first degree relative
• Cardiovascular conditions: recent stroke (\< 1 year from informed consent), recent myocardial infarction (\< 1 year from informed consent), uncontrolled hypertension (\>150/100 mm Hg) or recent arrhythmia (\< 1 year from informed consent; clinically significant arrhythmia requiring treatment at hospital)
• Liver (Child-Pughs Class C) or kidney (Creatinin clearance \< 30 mL/min) failure
• Heart failure (the New York Heart Association Functional Classification (NYHA) class III or IV)
• Chronic respiratory failure (requiring long-term oxygen therapy (LTOT) and/or Global Initiative for Chronic Obstructive Lung Disease system (GOLD) stage 3 or higher)
• Previous anaphylactic reaction to ketamine or midazolam
• Illegal use of ketamine the last 6 months

Sponsors & Collaborators

• University Hospital of North Norway: lead
• University of Exeter: collaborator

MeSH Terms

Conditions

Depression; Alcoholism; Behavior, Addictive

Interventions

Ketamine; Midazolam

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ole K Grønli, Assoc Prof

  University Hospital of North Norway

  STUDY DIRECTOR

• Andreas W Blomkvist, M.D.

  University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas W Blomkvist, M.D.

CONTACT

41694637; andreas.wahl.blomkvist@unn.no

Ole K Grønli, Assoc Prof

CONTACT

91713535; ole.k.gronli@unn.no

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2023
• First Posted: October 19, 2023
• Study Start: January 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09