Exenatide For Reducing the Reinforcing Effects of Cocaine

NCT06252623 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: H-52307
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cocaine Use Disorder

Keywords

cocaine; GLP-1; exenatide; cocaine use disorder

Outcome Measures

Primary Outcomes (2)

• Proportion of up to 10 active cocaine doses

  The primary outcome measure will be the proportion of up to 10 active cocaine doses (i.e., 20 and 40 mg) self-administered post-treatment.

  6 weeks

• Subjective Effects

  Subjective effects produced by cocaine or placebo will be measured using a visual analog scale (VAS) form. Visual analog scales rely on a visual cue (a ten-centimeter horizontal line anchored with the phrases "0 - not at all" to "100 - extremely") to evaluate the subjective effects of amphetamine. Instructions require that patients bisect the line at the point matching their "current" subjective states after ingesting a substance.

  6 weeks

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  6 weeks

Study Arms (2)

Drug: Exenatide 2 mg [Bydureon]

EXPERIMENTAL

Participants will receive once-weekly subcutaneous exenatide (2 mg) injections for 6 weeks.

Drug: Exenatide

Drug: Placebo

PLACEBO COMPARATOR

Participants will receive once-weekly subcutaneous saline (i.e., placebo) injections for 6 weeks.

Drug: Placebo

Interventions

Exenatide DRUG

Exenatide will be purchased commercially as Bydureon® for subcutaneous injection and administered at 2 mg once a week for 6 weeks. Each single-dose, dual-chamber pen contains 0.65 mg of diluent and 2 mg of exenatide, which remains isolated until mixed.

Also known as: Bydureon

Drug: Exenatide 2 mg [Bydureon]

Placebo DRUG

Sterile saline will be used as the placebo and administered subcutaneously once a week for 6 weeks.

Also known as: saline

Drug: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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.
• Severe cardiovascular disease (history of myocardial infarction, life-threatening arrhythmia, or worsening angina pectoris).
• Severe gastrointestinal disease (i.e., severe gastroparesis).
• Previous history of pancreatitis or risk of pancreatitis.
• Creatinine clearance \<45 or end stage renal disease (ESRD).
• 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).
• Participation in a clinical trial within 30 days of admission.
• Positive urine pregnancy test or females trying to conceive, donated ova, are pregnant, or are lactating or breast feeding at screening or throughout study.

Sponsors & Collaborators

• Christopher D. Verrico: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Exenatide; Sodium Chloride

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Christopher D Verrico, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized, double-blind, placebo-controlled

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 12, 2024
• Study Start: August 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 13, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)