Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06090422
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-19
First Post:
2023-07-01
Brief Title:
Ketamine for Combined Depression and Alcohol Use Disorder
Sponsor:
University Hospital of North Norway
Organization:
University Hospital of North Norway
Study Overview
Official Title:
Ketamine for Combined Depression and Alcohol Use Disorder A Blinded Randomized Active Placebo-controlled Trial the KeDA Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KeDA
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
Detailed Description:
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 contraindications 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 days 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
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 contraindications 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 days 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1293-2654 | OTHER | WHO UTN | None |
| 2023-506052-24 | EUDRACT_NUMBER | None | None |