Exenatide For Reducing the Reinforcing Effects of Cocaine (NCT06252623) | Clinical Trial Compass
WithdrawnPhase 1
Exenatide For Reducing the Reinforcing Effects of Cocaine
Stopped: The study was closed due to the inability to acquire the study drug.
United States0Started 2024-08-01
Plain-language summary
This study will determine the safety and tolerability of exenatide (Bydureon®) as a pharmacotherapy for cocaine use disorder. An inpatient human laboratory study will be conducted in which the self-administration of cocaine, as well as the subjective and physiological effects of cocaine, are evaluated during maintenance on placebo and exenatide.
Although exenatide (Bydureon) is approved by the Food and Drug Administration (FDA) for the treatment of type 2 diabetes, it has not been approved by the FDA to treat cocaine use; therefore, it is called an investigational drug.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. English-speaking
. Male or female ≥ 18 and ≤ 65 years of age
. Willing and able to provide written informed consent and participate in all required study activities
. Self-reported recent use of smoked or IV COC verified by a COC positive urine (≥ 150 ng/mL)
. Report using COC for ≥ 10 years and using ≥ 2 grams of COC/week
. Have vital signs as follows, resting pulse between 50 and 95 bpm, blood pressure (BP) between 90-150 mmHg systolic and 45-95 mmHg diastolic.
. Have hematology and chemistry laboratory tests that are within reference limits (±10%), with the following exception, pancreatic tests (lipase and amylase) must be within normal limits
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Have a medical history, physical examination, electrocardiogram (ECG), drug-use history, and the Mini-International Neuropsychiatric Interview (M.I.N.I.) demonstrating no clinically significant contraindications for study participation, in the judgment of a Study Physician and the Principal Investigator.
Exclusion criteria
. Clinically significant medical conditions .
. Meet diagnostic criteria for substance-use disorders other than for CUD that in the opinion of the study physician would comprise the well-being of the participant.
. Seeking treatment for a substance use disorder.
. Any laboratory test deemed clinically significant by the study physician.
. Type 1 or type 2 Diabetes Mellitus (HbA1C level of ≥6.5%)
. Previous medically adverse reaction to the study medications (Bydureon) or COC.
. Medication use that might interact with COC or exenatide, or otherwise compromise safety.
. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.