Using exenatide to reduce cocaine cravings

A Human Laboratory Study of Exenatide for Reducing the Reinforcing Effects of Cocaine

This study is testing if the diabetes medication exenatide can help reduce cravings for cocaine in people struggling with cocaine addiction.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Baylor College of Medicine (Academic / other)
• Drugs / interventions: CART
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06252623 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of exenatide, a medication approved for type 2 diabetes, as a potential treatment for cocaine use disorder. Participants will be monitored in an inpatient setting to assess the effects of exenatide compared to a placebo on cocaine self-administration and its subjective and physiological effects. The goal is to explore how exenatide may enhance the effectiveness of existing behavioral therapies for cocaine addiction. This research is part of a broader effort to develop pharmacotherapies that can support recovery from substance use disorders.

Who should consider this trial

Good fit: Ideal candidates are English-speaking adults aged 18 to 65 who have a long history of cocaine use and meet specific health criteria.

Not a fit: Patients who do not meet the inclusion criteria or have significant health contraindications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new pharmacological option to help individuals struggling with cocaine addiction.

How similar studies have performed: While the use of GLP-1 receptor agonists for cocaine use disorder is novel, preclinical studies have shown promising results in reducing drug-seeking behaviors.

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.

Where this trial is running

Houston, Texas

• Michael E. DeBakey VA Medical Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Christopher D Verrico, PhD — Baylor College of Medicine
• Study coordinator: Christopher D Verrico, PhD

Conditions Cocaine Use Disorder; cocaine; GLP-1; exenatide; cocaine use disorder