A Human Laboratory Study of Exenatide for Reducing the Reinforcing Effects of Cocaine
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.
• 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.
• 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),
∙ oral contraceptives,
‣ contraceptive sponge,
‣ patch,
‣ double barrier (diaphragm/spermicidal or condom/spermicidal),
‣ intrauterine contraceptive system,
‣ etonogestrel implant,
‣ medroxyprogesterone acetate contraceptive injection,
‣ complete abstinence from sexual intercourse, and/or
‣ hormonal vaginal contraceptive ring
⁃ Women of child-bearing potential must provide negative urine pregnancy tests prior to randomization, and at study visits as indicated in the Research Strategy
⁃ No contraindications/allergies to COC or exenatide
⁃ Cardiovascular and subjective responses to COC within acceptable