A Phase 1/2 interventional study of Ketamine Hydrochloride and Midazolam Hydrochloride in Depression and Alcohol Use Disorder, sponsored by University Hospital of North Norway. Recruiting at 1 site in Norway. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by University Hospital of North Norway · Phase 1/2, Interventional, and Treatment
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.
Depression and alcohol use disorder (AUD) often coexist and can create significant challenges for individuals seeking effective treatment. Traditional treatment approaches have shown limited success in addressing both conditions simultaneously. Ketamine has shown to have promising rapid antidepressant effects and a possible role in the treatment of substance use disorders. By targeting both depression and AUD simultaneously, ketamine has the potential to offer dual benefits, improving depressive symptoms while addressing alcohol cravings or consumption. Furthermore, rapid relief from depressive symptoms may enhance motivation for recovery, reduce the risk of relapse, and improve overall treatment engagement and outcomes. Although ketamine is generally considered safe when administered under medical supervision, the safety profile in individuals with comorbid depression and AUD needs further investigation. The overall objective of this study is to examine the safety and efficacy of ketamine on adults with depression and AUD that are admitted for standard inpatient addiction therapy.
The study will only include adults with at least moderate depression and alcohol use disorder as their primary substance use disorder that are admitted for inpatient addiction therapy. Participants that are unable to give informed consent or have contraindication(s) for ketamine will be excluded.
After screening and enrollment, participants will undergo baseline assessments with measures on depression (using Montgomery-Åsberg Depression Rating Scale (MADRS) and Beck Depression Inventory-II (BDI-II)), alcohol use (using Timeline Follow-Back method (TLFB)), alcohol craving (using Short version of Alcohol Craving Questionnaire (ACQ-Short) and Penn Alcohol Craving Scale (PACS)) and neurocognitive function (using Cambridge Neuropsychological Test Automated Battery (CANTAB)). Participants will then be randomized to intervention group or control group. The intervention group will receive ketamine as four single doses, given biweekly for two weeks. The control group will receive midazolam as active placebo. Participants will undergo several follow-up assessments after treatment (1-2 day(s), 1 week, 2 weeks and 4 weeks after treatment). Final follow-up assessment will be 6 months after baseline.
By using open questions and specific instruments for assessing adverse effects associated with ketamine (using modified version of Ketamine Side Effect Tool (mKSET)), the trial will assess the frequency, severity and duration of any adverse events and severe adverse events. All adverse events will be evaluated with regards to its causal relationship to ketamine. In addition, physician-assessed and patient-assessed tolerability will be registered. Changes in neurocognitive function from baseline will be assessed after treatment.
Changes in depression will be measured several times using rater-blinded MADRS-assessment and self-report instrument (BDI-II). Measures of alcohol use (TLFB), alcohol craving (ACQ-short and PACS), relapse risk and time until relapse will used as measures on alcohol use disorder following treatment. Several exploratory objectives will be examined, including changes in alcohol dependence severity (using Severity of Alcohol Dependence Questionnaire (SADQ)), changes in quality of life (using World Health Organizations brief quality of life questionnaire (WHOQOL-BREF)), changes in self-reported treatment effectiveness (using Treatment Effectiveness Assessment (TEA)) and changes in anxiety (using Generalized Anxiety Disorder scale (GAD-7)). Finally, data on the subjective experience of the treatment (using Ego Dissolution Inventory (EDI), Emotional Breakthrough Inventory (EBI) and Mystical Experience Questionnaire (MEQ30)) will be collected and used in a regression model with baseline measures to assess predictors of treatment response on measures of depression and AUD .
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 34 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →University Hospital of North Norway is the lead sponsor of 152 studies on the registry; 24 are open to participants now.
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Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ketamine, 0,8 mg/kg body weight, given as four single doses (biweekly for two weeks)
Drug: Ketamine Hydrochloride
Midazolam, 0,8 mg/kg body weight, given as four single doses (biweekly for two weeks)
Drug: Midazolam Hydrochloride
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
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
Depression
Change from baseline using rater-blinded Montgomery-Åsberg Depression Rating Scale (MADRS) (range 0-60; higher score indicate worse outcome)
Time frame: Within 3 days after final treatment session
Alcohol craving tonic
Penn Alcohol Craving Scale (PACS) (range 0-30; higher score indicate worse outcome)
Time frame: Repeated measurements from baseline and 1 day, 1 week, 2 weeks and 4 weeks after final treatment session
Alcohol craving phasic
Alcohol Craving Questionnaire - Short version (ACQ-short) (range 12-84; higher score indicate worse outcome)
Time frame: Repeated measurements from baseline and 1 day, 1 week, 2 weeks and 4 weeks after final treatment session
Depression response/remission
Rates of response (50% or more reduction in MADRS from baseline) and remission (9 points or less in MADRS)
Time frame: Repeated measurements from baseline and 1 day, 1 week, 2 weeks and 4 weeks after final treatment session
Relapse risk
Incidence of relapse in each group (defined as two or more consecutive heavy drinking days)
Time frame: From baseline until 6 months after baseline
Time until relapse
Average time from final treatment session until relapse
Time frame: From baseline until 3 and 6 months after baseline
Duration of antidepressant effect (blinded-rater assessed)
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) (range 0-60; higher score indicate worse outcome)
Time frame: From baseline until 6 months after baseline
Duration of antidepressant effect (self-report)
Change in the Beck Depression Inventory-II (BDI-II) (Range 0-63; higher score indicate worse outcome)
Time frame: From baseline until 6 months after baseline
Tolerability using the ketamine side effect tool (KSET)
Physician-reported tolerability of each treatment session (good, moderate and poor)
Time frame: Up to 1 month
Tolerability using the ketamine side effect tool (KSET)
Patient-reported tolerability of each treatment session (good, moderate and poor)
Time frame: Up to 1 month
Cambridge Neuropsychological Test Automated Battery (CANTAB): Stop Signal Task (SST); Spatial Working Memory (SWM) task; Intra-Extra Dimensional Shift (IED) task; Paired Associates Learning (PAL) task; Emotional Bias Task (EBT)
Assess within- and between-group changes in neurocognitive function from baseline to within three days from the final treatment session: SST (Range 0-1000; Lower score indicate better outcome); SWM (Range: 2-14; Lower score indicates better outcome); IED (Range: 0-402; Lower score indicates better outcome); PAL (Range: 0-70; Lower score indicates better outcome); EBT (Range: 0-15; Higher score indicates better outcome (more happy))
Time frame: Within 3 days after final treatment session
Adverse reaction frequency
Frequency of adverse reactions
Time frame: Up to 6 months
Adverse reaction severity
Number of mild, moderate and severe adverse reactions
Time frame: Up to 6 months
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Studies of the drug tested here: Ketamine
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