Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06233799
Status:
RECRUITING
Last Update Posted:
2024-01-31
First Post:
2024-01-09
Brief Title:
Trial of NaltrexoneBupropion for the Treatment of Methamphetamine Use Disorder
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Randomized Placebo-Controlled Multi-Site Trial of Extended-Release Naltrexone InjectionBupropion XL Tablets in the Treatment of Methamphetamine Use Disorder
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
The primary objective of this study is to evaluate the efficacy of extended release naltrexone plus bupropion XL XR-NTXBUP-XL compared to matched injectable and oral placebo iPLBoPLB in reducing methamphetamine MA use in individuals with moderate or severe methamphetamine use disorder MUD seeking to stop or reduce MA use
Detailed Description:
This is a double-blind placebo-controlled randomized clinical trial in which 360 individuals with moderate or severe MUD will be randomly assigned at a 11 ratio to receive either 1 extended release naltrexone XR-NTX as Vivitrol plus once daily oral extended release bupropion BUP-XL tablets the XR-NTXBUP-XL group or 2 both the matching injection placebo iPLB and once daily oral placebo oPLB tablets the iPLBoPLB group The study intervention consists of a 12-week treatment phase It is hypothesized that the XR-NTXBUP-XL arm will be associated with a greater number of responders defined as participants who provide at least 3 MA-negative urine drug screens UDS out of 4 samples obtained during the evaluation period ie Weeks 11-12 of the 12-week long treatment phase relative to the iPLBoPLB arm Secondary objectives include evaluating the effect of the extended release naltrexone plus bupropion XL XR-NTXBUP-XL arm compared to the iPLBoPLB arm on safety other substance use outcomes depression scores quality of life overall functioning clinic attendance and medication adherence
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?:
True
Is an FDA AA801 Violation?:
None