Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538285
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Ketamine Therapy for Methamphetamine Use Disorder HIV
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Trial of Ketamine-assisted Psychotherapy for Methamphetamine Use Disorder and HIV Risk Reduction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KetaMet
Brief Summary:
The goal of this clinical trial is to learn whether it is possible to use intramuscular IM ketamine in combination with psychotherapy to treat moderate-to-severe methamphetamine use disorder MeUD in publicly insured patients with or at-risk for HIV disease The main questions it aims to answer are
Do publicly insured patients find ketamine-assisted psychotherapy feasible and acceptable as a potential treatment for MeUD
Is IM ketamine safe and tolerable among patients with MeUD
Participants will
Receive 3 monitored doses of IM ketamine
Have 3 preparation and 4 integration psychotherapy visits
Report their daily amounts of methamphetamine used prior to during and up to 3 months following the intervention
Do publicly insured patients find ketamine-assisted psychotherapy feasible and acceptable as a potential treatment for MeUD
Is IM ketamine safe and tolerable among patients with MeUD
Participants will
Receive 3 monitored doses of IM ketamine
Have 3 preparation and 4 integration psychotherapy visits
Report their daily amounts of methamphetamine used prior to during and up to 3 months following the intervention
Detailed Description:
This is a single-arm pilot feasibility trial N12 of 3 doses of ketamine hydrochloride 050-075 mgkg IM administered approximately once weekly in combination with 7 sessions of manualized psychotherapy for publicly insured patients with moderate-to-severe methamphetamine use disorder MeUD who have or are at-risk for HIV Participants will be administered 3 preparatory psychotherapy visits over the 14 days prior to their first ketamine visit a psychotherapy integration visit within 1-3 days following each ketamine visit and a final integration visit about 1 week following their last ketamine visit This 10-visit Ketamine-Assisted Psychotherapy KAP treatment intervention will last about 5 weeks in duration and 2 follow-up assessment visits will be conducted at 4 and 12 weeks following KAP
Participants will receive ketamine 050 mgkg IM during their initial dosing visit and either ketamine 050 mgkg IM or 075 mgkg IM at each subsequent dosing visit depending on their toleration of prior doses
Screening data will be reviewed to determine subject eligibility Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study
Evaluations will be taken at baseline and each of the study visits
The total duration of subject participation will be up to 119 days-including 5 weeks ie 35 days for the KAP intervention with follow-up assessment visits at 4 weeks ie 28 days and 12 weeks ie 84 days post-intervention
The total duration of the study is expected to be 12 months
Participants will receive ketamine 050 mgkg IM during their initial dosing visit and either ketamine 050 mgkg IM or 075 mgkg IM at each subsequent dosing visit depending on their toleration of prior doses
Screening data will be reviewed to determine subject eligibility Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study
Evaluations will be taken at baseline and each of the study visits
The total duration of subject participation will be up to 119 days-including 5 weeks ie 35 days for the KAP intervention with follow-up assessment visits at 4 weeks ie 28 days and 12 weeks ie 84 days post-intervention
The total duration of the study is expected to be 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None