Cocaine Use DisorderPhase 1NCT06252623
Exenatide For Reducing the Reinforcing Effects of Cocaine
A Phase 1 study testing Exenatide in people with Cocaine Use Disorder, run by Christopher D. Verrico at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cocaine Use Disorder
- What is being tested?
- Exenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
- 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.
- Have a history of suicidal ideation.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
About this study
Official title: 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.
Read the detailed description
Cocaine (COC) use disorder (CUD) remains a significant medical, social, and legal concern. According to the 2019 National Survey on Drug Use and Health, approximately 1 million Americans meet the criteria for CUD. Behavioral therapies, such as cognitive-behavioral therapy (CBT), are the mainstay of current treatment approaches for CUD. However, because CBT alone has limited efficacy, the identification and development of pharmacotherapy that enhances the effectiveness of CBT is a high priority. Therefore, developing evidence-based interventions to reduce adverse outcomes associated with drug use and support the long-term recovery of people following treatment are top priorities for National Institute on Drug Abuse (NIDA) research. To that end, NIDA supports a dual strategy to accelerate medication development for CUD: (1) translating preclinical knowledge to target novel pathways and circuits and (2) repurposing medications already approved for other indications.
There is now substantial preclinical evidence that glucagon-like peptide-1 (GLP-1) receptor (GLP-1R) agonists attenuate behaviors that model both the consumption and seeking of highly palatable food and several commonly abused drugs, including alcohol, cocaine, and nicotine. The neurobiological mechanisms underlying food intake and drug-seeking overlap to a degree. Homeostatic and hedonic pathways regulate food intake. The homeostatic pathway regulates energy balance, while the hedonic pathway can override homeostatic regulation during periods of relative energy abundance, increasing the desire to consume highly palatable foods. In the homeostatic pathway, food intake stimulates the production and secretion of incretin hormones and satiation factors, like GLP-1, via both intestinal L-cells and neurons in the nucleus of the solitary tract (NTS). GLP-1-producing neurons of the NTS project to the arcuate nucleus (ARC) of the hypothalamus. In the ARC, GLP-1R activation suppresses feeding by activating anorexigenic neurons, which contain cocaine- and amphetamine-regulated transcript (CART), and inhibiting orexigenic neurons. NTS neurons also project to the ventral tegmental area (VTA), the nucleus accumbens (NAc), the laterodorsal tegmental nucleus (LDT), and the lateral septum. GLP-1 binding, messenger ribonucleic acid (mRNA), and immunoreactivity are detected in these same areas, as well as on VTA projections to the NAc and LDT projections to both the NAc and VTA. Direct activation of GLP-1R in the VTA,[10] NAc, LDT, or the lateral septum decreases palatable food intake, underscoring the critical role of GLP-1 in regulating the hedonic value of food.
The overall objective of this application is to determine if GLP-1R agonism is a viable treatment strategy for CUD. This goal will be achieved through the conduct of a rigorous human clinical pharmacology study in which non-treatment-seeking COC users (n=44) will be randomized (1:1) to placebo or extended-release (XR) exenatide (i.e., exenatide dose is a between-subject factor) for six weeks. The 6-week maintenance period, sufficient to achieve steady-state, will result in more stable concentrations of clinically effective doses before assessing treatment effects. Before and after the 6-week maintenance period, the investigators will determine COC (0, 20, 40 mg: IV) self-administration rates. To accurately predict clinical efficacy, the investigators will use forced-choice procedures in which participants choose to either self-administer COC or receive money.
- Conditions
- Cocaine Use Disorder
- Being tested
- Exenatide, Placebo
- Keywords
- cocaine, GLP-1, exenatide, cocaine use disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
Also called Bydureon
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.
PlaceboDrug
Also called saline
Sterile saline will be used as the placebo and administered subcutaneously once a week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Drug: Exenatide 2 mg [Bydureon] | Experimental | Participants will receive once-weekly subcutaneous exenatide (2 mg) injections for 6 weeks. Receives: Drug: Exenatide |
| Drug: Placebo | Placebo comparator | Participants will receive once-weekly subcutaneous saline (i.e., placebo) injections for 6 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Aug 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: The study was closed due to the inability to acquire the study drug.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher D. Verrico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christopher D. Verrico, Baylor College of Medicine
- Investigators
- Christopher D Verrico, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252623
- Sponsor's protocol ID
- H-52307
- Status last verified
- Oct 2025
- First submitted
- 29 Jan 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Human Laboratory Study of Exenatide for Reducing the Reinforcing Effects of Cocaine
- ClinicalTrials.gov ID
- NCT06252623
- Acronym / sponsor ID
- H-52307
- Conditions
- Cocaine Use Disorder
- Keywords
- cocaine, GLP-1, exenatide, cocaine use disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was closed due to the inability to acquire the study drug.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Christopher D. VerricoUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cocaine (COC) use disorder (CUD) remains a significant medical, social, and legal concern. According to the 2019 National Survey on Drug Use and Health, approximately 1 million Americans meet the criteria for CUD. Behavioral therapies, such as cognitive-behavioral therapy (CBT), are the mainstay of current treatment approaches for CUD. However, because CBT alone has limited efficacy, the identification and development of pharmacotherapy that enhances the effectiveness of CBT is a high priority. Therefore, developing evidence-based interventions to reduce adverse outcomes associated with drug use and support the long-term recovery of people following treatment are top priorities for National Institute on Drug Abuse (NIDA) research. To that end, NIDA supports a dual strategy to accelerate medication development for CUD: (1) translating preclinical knowledge to target novel pathways and circuits and (2) repurposing medications already approved for other indications.
There is now substantial preclinical evidence that glucagon-like peptide-1 (GLP-1) receptor (GLP-1R) agonists attenuate behaviors that model both the consumption and seeking of highly palatable food and several commonly abused drugs, including alcohol, cocaine, and nicotine. The neurobiological mechanisms underlying food intake and drug-seeking overlap to a degree. Homeostatic and hedonic pathways regulate food intake. The homeostatic pathway regulates energy balance, while the hedonic pathway can override homeostatic regulation during periods of relative energy abundance, increasing the desire to consume highly palatable foods. In the homeostatic pathway, food intake stimulates the production and secretion of incretin hormones and satiation factors, like GLP-1, via both intestinal L-cells and neurons in the nucleus of the solitary tract (NTS). GLP-1-producing neurons of the NTS project to the arcuate nucleus (ARC) of the hypothalamus. In the ARC, GLP-1R activation suppresses feeding by activating anorexigenic neurons, which contain cocaine- and amphetamine-regulated transcript (CART), and inhibiting orexigenic neurons. NTS neurons also project to the ventral tegmental area (VTA), the nucleus accumbens (NAc), the laterodorsal tegmental nucleus (LDT), and the lateral septum. GLP-1 binding, messenger ribonucleic acid (mRNA), and immunoreactivity are detected in these same areas, as well as on VTA projections to the NAc and LDT projections to both the NAc and VTA. Direct activation of GLP-1R in the VTA,[10] NAc, LDT, or the lateral septum decreases palatable food intake, underscoring the critical role of GLP-1 in regulating the hedonic value of food.
The overall objective of this application is to determine if GLP-1R agonism is a viable treatment strategy for CUD. This goal will be achieved through the conduct of a rigorous human clinical pharmacology study in which non-treatment-seeking COC users (n=44) will be randomized (1:1) to placebo or extended-release (XR) exenatide (i.e., exenatide dose is a between-subject factor) for six weeks. The 6-week maintenance period, sufficient to achieve steady-state, will result in more stable concentrations of clinically effective doses before assessing treatment effects. Before and after the 6-week maintenance period, the investigators will determine COC (0, 20, 40 mg: IV) self-administration rates. To accurately predict clinical efficacy, the investigators will use forced-choice procedures in which participants choose to either self-administer COC or receive money.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Drug: Exenatide 2 mg [Bydureon] | Experimental | Drug: ExenatideParticipants will receive once-weekly subcutaneous exenatide (2 mg) injections for 6 weeks. |
| Drug: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive once-weekly subcutaneous saline (i.e., placebo) injections for 6 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (18 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExenatideAlso: BydureonExenatide 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. | Drug | Drug: Exenatide 2 mg [Bydureon] |
| PlaceboAlso: salineSterile saline will be used as the placebo and administered subcutaneously once a week for 6 weeks. | Drug | Drug: Placebo |
Primary outcome
Proportion of up to 10 active cocaine doses
Time frame: 6 weeks
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.
Subjective Effects
Time frame: 6 weeks
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher D Verrico, PhD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exenatide in people with Cocaine Use Disorder, run by Christopher D. Verrico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of up to 10 active cocaine doses (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.