Exenatide For Reducing the Reinforcing Effects of Cocaine

Launched by CHRISTOPHER D. VERRICO · Feb 7, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called exenatide (also known as Bydureon), which is typically used for treating type 2 diabetes, can help reduce the urge to use cocaine in people with cocaine use disorder. The study aims to understand how safe the medication is and how well it works when people are given cocaine in a controlled environment. Participants will be monitored while receiving either exenatide or a placebo (a non-active substance) to see how their body responds to cocaine under each condition.

To be eligible for this trial, participants must be between 18 and 65 years old, speak English, and have a history of using cocaine for at least 10 years. They should have been using cocaine recently, confirmed by a urine test. Additionally, they need to be in good health according to specific medical tests and not have any significant medical conditions that could complicate their participation. During the trial, participants will undergo various assessments and will be closely monitored for their health and safety. It's important to note that exenatide is still considered investigational for this use, meaning it hasn't been officially approved for treating cocaine addiction yet.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. English-speaking
• • 2. Male or female ≥ 18 and ≤ 65 years of age
• • 3. Willing and able to provide written informed consent and participate in all required study activities
• • 4. Self-reported recent use of smoked or IV COC verified by a COC positive urine (≥ 150 ng/mL)
• • 5. Report using COC for ≥ 10 years and using ≥ 2 grams of COC/week
• • 6. 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.
• • 7. 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
• • 8. 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.
• • 9. Agree (if the subject is female and of child-bearing potential) to use at least one of the following methods of birth control from time of the first administration of the study drug to at least 7 days post the last dose of study drug, unless the partner is surgically sterile (underwent vasectomy),
• • 1. oral contraceptives,
• • 2. contraceptive sponge,
• • 3. patch,
• • 4. double barrier (diaphragm/spermicidal or condom/spermicidal),
• • 5. intrauterine contraceptive system,
• • 6. etonogestrel implant,
• • 7. medroxyprogesterone acetate contraceptive injection,
• • 8. complete abstinence from sexual intercourse, and/or
• • 9. hormonal vaginal contraceptive ring
• • 10. Women of child-bearing potential must provide negative urine pregnancy tests prior to randomization, and at study visits as indicated in the Research Strategy
• • 11. No contraindications/allergies to COC or exenatide
• • 12. Cardiovascular and subjective responses to COC within acceptable
• Exclusion Criteria:
• • 1. Clinically significant medical conditions .
• • 2. 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.
• • 3. Seeking treatment for a substance use disorder.
• • 4. Any laboratory test deemed clinically significant by the study physician.
• • 5. Type 1 or type 2 Diabetes Mellitus (HbA1C level of ≥6.5%)
• • 6. Previous medically adverse reaction to the study medications (Bydureon) or COC.
• • 7. Medication use that might interact with COC or exenatide, or otherwise compromise safety.
• • 8. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
• • 9. Severe cardiovascular disease (history of myocardial infarction, life-threatening arrhythmia, or worsening angina pectoris).
• • 10. Severe gastrointestinal disease (i.e., severe gastroparesis).
• • 11. Previous history of pancreatitis or risk of pancreatitis.
• • 12. Creatinine clearance \<45 or end stage renal disease (ESRD).
• • 13. Contraindications to treatment with exenatide (e.g., personal of family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type-2; history of pancreatitis or risk of pancreatitis).
• • 14. Participation in a clinical trial within 30 days of admission.
• • 15. Positive urine pregnancy test or females trying to conceive, donated ova, are pregnant, or are lactating or breast feeding at screening or throughout study.
• • 16. Positive urine screen for drugs-of-abuse, other than COC or marijuana, or breath alcohol test. Note, if positive for opioids or oxycodone but recent opioid use for acute pain is reported by the subject, then the subject can be included at the discretion of the Primary Investigator and/or Study Physician.
• • 17. Have a history of suicidal ideation.
• • 18. Have any illness or condition which in the opinion of the Principal Investigator and/or the Study Physician would preclude safe and/or successful completion of the study.