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 range18 Years – 65 Years

SexALL

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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
✓. 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

What they're measuring

Proportion of up to 10 active cocaine doses

Timeframe: 6 weeks

Subjective Effects

Timeframe: 6 weeks

Trial details

NCT IDNCT06252623

SponsorChristopher D. Verrico

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-01

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