WITHDRAWN

Exenatide For Reducing the Reinforcing Effects of Cocaine

Conditions

Cocaine Use Disorder cocaine GLP-1 exenatide

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-08-01

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:WITHDRAWN

Study ID

NCT06252623

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Principal Investigator

Christopher D Verrico, PhD

PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Study Locations (Sites)

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Christopher D. Verrico

Christopher D Verrico, PhD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-01

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-08-01

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

cocaine
GLP-1
exenatide
cocaine use disorder

Additional Relevant MeSH Terms

Cocaine Use Disorder