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New treatment option for Cocaine Use Disorder
Official title Evaluation Of Semaglutide in Adults With Cocaine Use Disorder With and Without HIV
ClinicalTrials.gov ID: NCT06691243
What this study is testing
What is Semaglutide?
Semaglutide is an investigational medicine, given as an once-weekly injectable medicine, being studied as a potential treatment for cocaine use disorder.
Also referred to as Wegovy, 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 purpose of this research study is to find out if semaglutide is safe and well tolerated in adults with cocaine use disorder who do and do not have human immunodeficiency virus (HIV). Participants will complete a screening process and if you are able to participate, you will be assigned to one of two treatment groups: semaglutide or placebo.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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 65
You may be able to join if
- At least 18 years old
- Meet criteria for CUD according to the Diagnostic and Statistical Manual Version 5
- Used cocaine at least 7 out of the past 14 days
- Body Mass Index between 20 - 50 kg/m2
- English proficiency
You likely can't join if
- Triglycerides \> 500 mg/dL
- History of gall bladder disease
- Personal or family history of medullary thyroid carcinoma, or patients with a history of Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- History of diabetic retinopathy
- Being prescribed glucose-lowering medications
- An estimated glomerular filtration rate of less than 45 ml/min
See the full eligibility criteria
- At least 18 years old
- Meet criteria for CUD according to the Diagnostic and Statistical Manual Version 5
- Used cocaine at least 7 out of the past 14 days
- Body Mass Index between 20 - 50 kg/m2
- English proficiency
- In people of childbearing potential, agree to use an acceptable method of birth control
- Triglycerides \> 500 mg/dL
- History of gall bladder disease
- Personal or family history of medullary thyroid carcinoma, or patients with a history of Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- History of diabetic retinopathy
- Being prescribed glucose-lowering medications
- An estimated glomerular filtration rate of less than 45 ml/min
- Lifetime history of taking semaglutide or other GLP-1 RAs
- Current suicidal ideation or suicide attempts within the past 24 months
- Present diagnosis of diabetes mellitus OR screening hemoglobin A1C \>/= 6.5
- Use of weight-lowering medications
- History of gastric bypass surgery
- History of myocardial infarction or stroke within the past 12 months
- Pregnant, breastfeeding, or the patient intends to become pregnant during the next four months
- Any contraindicated medical issues identified by the study investigators
- Risk of conditions that are under Warning and Precautions section of OZEMPIC and WEGOVY including but not limited to known history or current report of clinically relevant hypoglycemia, gastroparesis, or pancreatic...
- Calcitonin value equal to or above 50 ng/L
- If completing the MRI portion of the study: claustrophobia or physical issues preventing MRI scan
- If completing the MRI portion of the study: presence of a metal device in the body (e.g. pacemaker. Infusion pump, aneurysm clip, metal prosthesis or plate
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- Baltimore, Maryland, 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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; Baltimore, Maryland, 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.