BridgeMD
New treatment option for Opioid Use Disorder
Official title GLP-1R Agonist Treatment for Opioid Use Disorder
ClinicalTrials.gov ID: NCT06548490
What this study is testing
What is Semaglutide Pen Injector?
Semaglutide Pen Injector is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for opioid use disorder.
Also referred to as Ozempic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age 18 to 75 years.
- Body mass index (BMI) \> 18.
- Able and willing to provide informed consent prior to any study-related activities.
- Current diagnosis of Diagnostic and Statistical Manual Diploma in Social Medicine (DSM)-5 Opioid Use Disorder (OUD) as per the Mini International...
- Currently receiving outpatient treatment for OUD and at least 2 weeks on buprenorphine (BUP) or 4 weeks on methadone at the study site and/or at an...
You likely can't join if
- Age \ 75 years.
- BMI \<18.
- Individuals who are pregnant, planning pregnancy, breastfeeding, or unwilling to use adequate contraceptive measures.
- Current use of glucagon-like peptide 1 receptor (GLP-1R) agonist.
- History of angioedema, serious hypersensitivity reaction, or anaphylactic reaction to semaglutide or another GLP-1R agonist.
- Personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome Type 2 (MEN 2) or thyroid...
See the full eligibility criteria
- Age 18 to 75 years.
- Body mass index (BMI) \> 18.
- Able and willing to provide informed consent prior to any study-related activities.
- Current diagnosis of Diagnostic and Statistical Manual Diploma in Social Medicine (DSM)-5 Opioid Use Disorder (OUD) as per the Mini International Neuropsychiatric Interview (MINI) or per the site clinic diagnosis...
- Currently receiving outpatient treatment for OUD and at least 2 weeks on buprenorphine (BUP) or 4 weeks on methadone at the study site and/or at an associated clinic at the time of enrollment.
- Have at least 1 urine test positive for opioids after 2 weeks on BUP or 4 weeks on methadone.
- Have positive self-reporting of opioid use after 2 weeks on BUP or 4 weeks on methadone.
- If anatomically capable of becoming pregnant and of childbearing age, is not pregnant (confirmed) or breastfeeding at the time of enrollment and agrees to use a medically accepted method of birth control or to abstain...
- Able to read and communicate in English to the level required to accept standard care and complete all study requirements.
- Able and willing to engage/adhere to the entirety of the study protocol (19 weeks).
- Not currently a prisoner.
- Age \ 75 years.
- BMI \<18.
- Individuals who are pregnant, planning pregnancy, breastfeeding, or unwilling to use adequate contraceptive measures.
- Current use of glucagon-like peptide 1 receptor (GLP-1R) agonist.
- History of angioedema, serious hypersensitivity reaction, or anaphylactic reaction to semaglutide or another GLP-1R agonist.
- Personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome Type 2 (MEN 2) or thyroid nodule.
- Type 1 diabetes or history of diabetic ketoacidosis.
- Type 2 diabetes mellitus or current use of a dipeptidyl peptidase-4 (DPP-4) inhibitor.
- Past 30-day use of Sincalide, Sulfonylureas, insulin and insulin products or other medications that may interact with semaglutide.
- Hypoglycemia on intake visit (blood glucose \< 60 mg/dL).
- End-stage renal failure, on dialysis, or glomerular filtration rate (GFR) \<30 mL/min per 1.73 square meters or previous renal transplant.
- End stage liver disease or previous liver transplant.
- Current or past diagnosis of pancreatitis, gastroparesis, or other severe gastrointestinal (GI) disease.
- Current or past diagnosis of gallbladder disease or gallstones.
- Serious cardiovascular disease within the past 6 months (e.g. uncontrolled hypertension, heart failure, significant cardiac arrhythmias, myocardial infarction, presence of angina pectoris, symptomatic coronary artery...
- Severe co-occurring psychiatric disorder (e.g., bipolar disorder, psychotic disorder, schizophrenia), and/or history or evidence of organic brain disease or dementia that would compromise safety or compliance with the...
- Significant risk of suicide requiring a different/higher level of care, according to the clinical judgment of the study physician or site principal investigator, or history of suicide attempts within the past 1 year...
- Treatment with any investigational drug in the one month preceding the study.
- Any contraindication to both methadone and BUP.
- Any contraindication to a GLP-1R agonist.
- Previous randomization for participation in this trial.
- Any other condition at screening that precludes safe participation in the trial in the judgment of the site PI or study physician.
- Plans for travel outside of the local area over the 19 weeks (1 week of baseline, 12 weeks of medication, 1 week wash-out, and follow-up after a further 28 days) that would interfere with visits during the study period...
- Currently a prisoner.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- New York, New York, United States
- Harrisburg, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; New York, New York, United States; Harrisburg, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.