Ignite Creation Date:
2024-07-17 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496750
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-03
Brief Title:
Ketamine for Methamphetamine Use Disorder
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
NIDA CTN-0132 Randomized Double-Blind Active Placebo-Controlled Trial of Ketamine for Methamphetamine Use Disorder KMD
Status:
RECRUITING
Status Verified Date:
2024-10
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:
KMD
Brief Summary:
This study aims to determine whether treatment response with IV ketamine is superior to treatment response with IV midazolam in adults with moderate to severe MUD
The study design is a 12-week randomized double-blind controlled trial comparing intravenous IV ketamine against IV midazolam delivered over six weeks in 120 adults with moderate to severe methamphetamine use disorder MUD
The study design is a 12-week randomized double-blind controlled trial comparing intravenous IV ketamine against IV midazolam delivered over six weeks in 120 adults with moderate to severe methamphetamine use disorder MUD
Detailed Description:
Effective management for methamphetamine use disorder MUD remains elusive despite widespread misuse of this stimulant Psychological interventions have demonstrated modest benefits and relapse rates are high There are currently no Food and Drug Administration FDA-approved pharmacotherapies for MUD This study explores the efficacy safety and feasibility for intravenous IV ketamine as a treatment for MUD and will help to determine the effect size for a larger multi-site trial of intravenous IV ketamine in MUD
Participants will receive either IV ketamine 050mgkg or IV midazolam 002mgkg over 45 minutes per infusion for a total of eight 8 infusions over six 6 weeks Medical management sessions with a study clinician will be provided to all participants once weekly from Weeks 1 through 6
The use of IV ketamine in this trial is consistent in dose 05 mgkg and duration of infusion 45-minute-long to other studies of ketamine for psychiatric disorders such as major depressive disorder and post-traumatic stress disorder both of which are often comorbid in individuals with MUD and substance use disorder However IV ketamine has not been directly evaluated as mono-pharmacotherapy in those with MUD yet
Additionally participants will be asked to participate in cognitive behavioral therapy CBT sessions once weekly from Weeks 1 through 12 on a non-infusion day
Participants will receive either IV ketamine 050mgkg or IV midazolam 002mgkg over 45 minutes per infusion for a total of eight 8 infusions over six 6 weeks Medical management sessions with a study clinician will be provided to all participants once weekly from Weeks 1 through 6
The use of IV ketamine in this trial is consistent in dose 05 mgkg and duration of infusion 45-minute-long to other studies of ketamine for psychiatric disorders such as major depressive disorder and post-traumatic stress disorder both of which are often comorbid in individuals with MUD and substance use disorder However IV ketamine has not been directly evaluated as mono-pharmacotherapy in those with MUD yet
Additionally participants will be asked to participate in cognitive behavioral therapy CBT sessions once weekly from Weeks 1 through 12 on a non-infusion day
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None