Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548490
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
GLP-1R Agonist Treatment for Opioid Use Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
GLP-1R Agonist Treatment for Opioid Use Disorder
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 goal of this clinical trial is to learn if semaglutide can reduce illicit opioid use in adults in outpatient treatment for opioid use disorder and who are receiving either buprenorphine or methadone maintenance treatment The main question it aims to answer is
Does semaglutide increase the likelihood that participants will refrain from using illicit and nonprescribed opioids
The investigators will compare semaglutide to a placebo a needle prick that contains no drug to see if semaglutide works to reduce use of illicit and nonprescribed opioids
The participants will
Take semaglutide or a placebo every week for 12 weeks
Visit the clinic every week for urine drug screening and pregnancy testing vital signs and to complete mental health and drug use questionnaires
Complete smartphone surveys sent at set times during the study
Does semaglutide increase the likelihood that participants will refrain from using illicit and nonprescribed opioids
The investigators will compare semaglutide to a placebo a needle prick that contains no drug to see if semaglutide works to reduce use of illicit and nonprescribed opioids
The participants will
Take semaglutide or a placebo every week for 12 weeks
Visit the clinic every week for urine drug screening and pregnancy testing vital signs and to complete mental health and drug use questionnaires
Complete smartphone surveys sent at set times during the study
Detailed Description:
The purpose of this study is to determine whether 12 weeks of once-weekly treatment with the glucagon-like peptide-1 receptor GLP-1R agonist semaglutide will reduce illicit opioid use over a 19 week period 133 days among individuals in outpatient treatment for opioid use disorder and who are receiving either buprenorphine or methadone maintenance treatment ie medication for opioid use disorder Following successful consent and screening participants will complete a baseline evaluation and be randomly assigned to semaglutide or placebo control arms in a 11 ratio using a permuted-block randomization algorithm stratified by site and and begin a 1-week baseline period Semaglutide injector pen or placebo will be administered as a subcutaneously SC once per week for 12 weeks starting at a dose of 025 mg SC and advanced on a fixed-flexible dose schedule based on tolerability to a target dose of 10 mg SC per week or the maximum tolerated dose if less than 10 mg Participants will receive study intervention in an outpatient setting for a total of 12 weeks After 4 weeks at the target 10 mg or maximum the highest dose tolerated dose participants will discontinue semaglutide or placebo and be observed for an additional week wash-out period A final follow-up visit will then take place 5 weeks after the last treatment visit
During each study visit participants will undergo urine drug screening and pregnancy testing vital signs collection and complete mental health and drug use questionnaires Participants will also complete smartphone surveys sent at set times during the study Blood samples will be collected at 2 of the visits screening and the study week 14 and a physical examination and medical history collection will be done at the baseline visit
During each study visit participants will undergo urine drug screening and pregnancy testing vital signs collection and complete mental health and drug use questionnaires Participants will also complete smartphone surveys sent at set times during the study Blood samples will be collected at 2 of the visits screening and the study week 14 and a physical examination and medical history collection will be done at the baseline visit
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