Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651177
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Evaluation of Tirzepatide As an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
NIDA CTN-0152 Evaluation of Tirzepatide As an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder a Pragmatic Multi-site Double-blind Randomized Placebo-controlled Trial TAB
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
TAB
Brief Summary:
The primary objective of this research study is to evaluate the effect of tirzepatide relative to placebo as an adjunct to BUP on retention substance use and sleep outcomes in individuals with OUD
Detailed Description:
This is a Phase 2 pragmatic multi-site double-blind randomized placebo-controlled intent-to-treat trial The selection of placebo as the comparator is considered the gold standard for medication trials Eligible participants will be randomized in a 11 ratio to tirzepatide or placebo balancing on site and buprenorphine BUP formulation transmucosal vs extended-release
Participants will receive tirzepatide or placebo based on randomized assignment with dose escalation of placebo following the schedule for tirzepatide and tirzepatide dosing being consistent with prescribing guidelines Participants will be administered a subcutaneous SQ study medication injection weekly and attend weekly research visits through 26 weeks post-randomization with longer research visits at 1 3 and 6 months post-randomization A follow-up visit for final safety measures will be completed at week 30 which takes into account tirzepatides long half-life
Duration of participation will be approximately 31 weeks for study participants Participants will be administered study medication and attend weekly research visits through 6 months post-randomization with longer research visits at 1- 3- and 6-months post-randomization Participants will be provided with a Fitbit to measure sleep BUP is not a study medication participants will receive BUP through their clinical provider A follow-up visit for final safety measures will be completed at week 30
Participants will receive tirzepatide or placebo based on randomized assignment with dose escalation of placebo following the schedule for tirzepatide and tirzepatide dosing being consistent with prescribing guidelines Participants will be administered a subcutaneous SQ study medication injection weekly and attend weekly research visits through 26 weeks post-randomization with longer research visits at 1 3 and 6 months post-randomization A follow-up visit for final safety measures will be completed at week 30 which takes into account tirzepatides long half-life
Duration of participation will be approximately 31 weeks for study participants Participants will be administered study medication and attend weekly research visits through 6 months post-randomization with longer research visits at 1- 3- and 6-months post-randomization Participants will be provided with a Fitbit to measure sleep BUP is not a study medication participants will receive BUP through their clinical provider A follow-up visit for final safety measures will be completed at week 30
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