Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639464
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Semaglutide for the Treatment of Opioid Use Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Semaglutide for the Treatment of Opioid Use Disorder a Pilot Randomized Controlled Trial
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:
None
Brief Summary:
The is a pilot 12-week double-blind placebo-controlled randomized trial of individuals with opioid use disorder OUD newly initiating buprenorphine to receive either weekly injections of semaglutide n23 or matching placebo n23 The primary aim is to determine the effects of semaglutide on cue-reactivity among individuals with OUD The secondary aim is to assess the preliminary efficacy safety and tolerability of semaglutide for OUD
Detailed Description:
Participants include N46 men and women with DSM5 diagnosis of OUD who are newly initiating sublingual buprenorphine SL-BUP defined as within 60 days of enrollment Only those participants who have attained stable SL-BUP dosing ie no change in dose for at least 30 days prior to enrollment and plan to remain on the SL-BUP for the duration of the trial will be eligible Potential participants will be screened and enrolled only if they meet full inclusion criteria After baseline procedures are complete participants will be randomized to semaglutide or placebo Following randomization participants will be scheduled for thirteen study visits Each visit will last approximately 1 hour except for study visits 7 and 13 which will take no more than 3 hours in order to conduct neurocognitive testing At each in-person visit participants will complete vital signs weight urine toxicology testing and a blood draws for glucose At all visits they will complete assessment of adverse events and questionnaires probing secondary outcomes ie anxiety and depression suicidality substance use opioid withdrawal symptoms craving questionnaire At each study visit the weekly dose of semaglutide or placebo will be administered as well as provided with buprenorphine Both participants and study staff including raters will be blinded to active drug vs placebo by using syringes drawn up by the The final follow-up visit scheduled within 2 weeks of the final weekly visit will assess self-reported side effects substance use and questionnaires The medication will be purchased from the manufacturer and stored in the BWH Investigational Drug Service IDS The IDS will then extract the semaglutide and draw the dose into syringes which will be matching visually with the placebo doses
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