Cocaine Use Disorder (CUD)Phase 1/2NCT07624227
The Impact of Cobenfy Maintenance on Cocaine's Effects
A Phase 1/2 study testing Cobenfy in people with Cocaine Use Disorder (CUD), run by Joshua A. Lile, Ph.D. at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if Cobenfy influences the effects of cocaine in people with cocaine use disorder. This trial will also provide information about the safety and tolerability of combining Cobenfy and cocaine. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cocaine Use Disorder (CUD)
- What is being tested?
- Cobenfy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to 30 Jun 2032
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must meet criteria for cocaine use disorder - report past month smoked or IV cocaine use, and provide a urine sample positive for recent cocaine use during screening.
- Female subjects of childbearing potential must be using an effective form of birth control (e.g., birth control pills, surgical sterilization, IUD, cervical cap with a spermicide, or abstinence). Exceptions include women reporting 12 months of spontaneous amenorrhea, 6 months of spontaneous amenorrhea with a follicle stimulating hormone (FSH) level > 40 mIU/mL, or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy. Urine pregnancy tests will be conducted prior to sessions to ensure that female subjects do not participate if pregnant.
- Able to speak and read English.
Who cannot join
- Chemistry values or screening outcomes including outside normal ranges that are deemed by the study physician to be clinically significant. Lipid levels are also included in this protocol as an additional check for cardiovascular health.
- Persistent hypertension >140/90 mmHg or tachycardia >100 bpm for three consecutive recordings during screening.
- AST, ALT or alkaline phosphatase >3x ULN.
- Creatinine levels >1.2x ULN will be repeated; subjects with creatinine re-test values remaining above this level will be excluded.
- Bilirubin levels >1.5x ULN will be repeated to determine trends; subjects with bilirubin increasing over time will be excluded.
- Subjects presenting with anemia (hematocrit < 36) or evidence of current infection (white blood cell count > 5) are referred to their PCP. If urine protein is greater than trace, urinalysis is repeated, and subjects with continued elevation is referred to their PCP. Subjects can be reconsidered for enrollment if these issues are resolved.
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- Electrocardiogram abnormalities, including:
- Atrial premature beats (>= 2 consecutive)
- Ventricular premature beats (Lown's Grade 3 or higher; >= 2 consecutive beats, multiform)
- Heart block (2nd or 3rd degree AV block or bundle branch block)
- Pre-excitation syndromes (Wolff-Parkinson-White or Lown-Ganong-Levine)
- QTc interval > 450 msec
- History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of head trauma with prolonged loss of consciousness, seizures or CNS tumors, or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation.
- First degree family member with significant premature cardiac comorbidity.
- Contraindications for Cobenfy not covered by other exclusion criteria including urinary retention, moderate/severe hepatic impairment, gastric retention and untreated narrow-angle glaucoma.
- Meet diagnostic criteria for psychoactive substance use disorder for substances other than cocaine or nicotine/caffeine that would require detoxification (i.e., alcohol, opioids, benzodiazepines or barbiturates). Negative urine/breath samples for these substances, and the absence of withdrawal, will be required during screening.
- Regular use of other medications, with the exception of hormone-based contraceptives for female subjects, daily multivitamins, short-term antibiotic prescriptions, and/or antiretrovirals for the hepatitis C virus.
- Vision or hearing problems that would preclude completion of experimental tasks.
- Poor venous access.
- Seeking treatment for SUD.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Psychopharmacology of Addiction Laboratory
Lexington, Kentucky, 40502
Frances Wagner, RN, 859-257-5388, fpwagn2@uky.edu
Joshua Lile, PhD
About this study
The goal of this clinical trial is to learn if Cobenfy influences the effects of cocaine in people with cocaine use disorder. This trial will also provide information about the safety and tolerability of combining Cobenfy and cocaine.
Researchers will compare Cobenfy to a placebo (a look-alike substance that contains no drug) to see if Cobenfy is a safe, tolerable and effective at blocking cocaine's effects in participants with cocaine use disorder.
Participants will:
- Participate in an 11-day inpatient trial
- Take Cobenfy or placebo twice per day.
- Participate in experimental sessions to test the effects of Cobenfy (or placebo) on the response to cocaine and cocaine self-administration.
- Conditions
- Cocaine Use Disorder (CUD)
- Being tested
- Cobenfy, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CobenfyDrug
Participants receive Cobenfy maintenance (100 mg xanomeline + 20 mg trospium twice daily) during the inpatient protocol, prior to IV cocaine self-administration.
PlaceboDrug
Participants receive matching placebo maintenance during the inpatient protocol prior to cocaine self-administration sessions.
| Study group | Role | What they receive |
|---|---|---|
| Cobenfy Maintenance | Experimental | Participants receive Cobenfy maintenance (100 mg xanomeline + 20 mg trospium twice daily) during the inpatient protocol, followed by IV cocaine self-administration and behavioral assessment sessions. Receives: Drug: Cobenfy |
| Placebo Maintenance | Placebo comparator | Participants receive placebo maintenance during the inpatient protocol, followed by IV cocaine self-administration and behavioral assessment sessions. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine Self-Administration Choice Behavior
Number of cocaine choices selected during progressive-ratio cocaine-versus-money choice sessions following Cobenfy or placebo maintenance.
Measured: During Inpatient Experimental Sessions (Days 6-11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Aug 2026
- Primary completion30 Jun 2032 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Use Disorder (CUD)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joshua A. Lile, Ph.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joshua A. Lile, Ph.D., University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624227
- Sponsor's protocol ID
- 105840
- Status last verified
- Aug 2026
- First submitted
- 28 May 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Cobenfy Maintenance on Cocaine's Effects
- ClinicalTrials.gov ID
- NCT07624227
- Acronym / sponsor ID
- 105840
- Conditions
- Cocaine Use Disorder (CUD)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Joshua A. Lile, Ph.D.University, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 30 Jun 2032 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 3 Jun 2026 (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.
The goal of this clinical trial is to learn if Cobenfy influences the effects of cocaine in people with cocaine use disorder. This trial will also provide information about the safety and tolerability of combining Cobenfy and cocaine.
Researchers will compare Cobenfy to a placebo (a look-alike substance that contains no drug) to see if Cobenfy is a safe, tolerable and effective at blocking cocaine's effects in participants with cocaine use disorder.
Participants will:
- Participate in an 11-day inpatient trial
- Take Cobenfy or placebo twice per day.
- Participate in experimental sessions to test the effects of Cobenfy (or placebo) on the response to cocaine and cocaine self-administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cobenfy Maintenance | Experimental | Drug: CobenfyParticipants receive Cobenfy maintenance (100 mg xanomeline + 20 mg trospium twice daily) during the inpatient protocol, followed by IV cocaine self-administration and behavioral assessment sessions. |
| Placebo Maintenance | Placebo comparator | Drug: PlaceboParticipants receive placebo maintenance during the inpatient protocol, followed by IV cocaine self-administration and behavioral assessment sessions. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Must meet criteria for cocaine use disorder - report past month smoked or IV cocaine use, and provide a urine sample positive for recent cocaine use during screening.
- Female subjects of childbearing potential must be using an effective form of birth control (e.g., birth control pills, surgical sterilization, IUD, cervical cap with a spermicide, or abstinence). Exceptions include women reporting 12 months of spontaneous amenorrhea, 6 months of spontaneous amenorrhea with a follicle stimulating hormone (FSH) level > 40 mIU/mL, or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy. Urine pregnancy tests will be conducted prior to sessions to ensure that female subjects do not participate if pregnant.
- Able to speak and read English.
Key exclusion criteria (20 listed)
- Chemistry values or screening outcomes including outside normal ranges that are deemed by the study physician to be clinically significant. Lipid levels are also included in this protocol as an additional check for cardiovascular health.
- Persistent hypertension >140/90 mmHg or tachycardia >100 bpm for three consecutive recordings during screening.
- AST, ALT or alkaline phosphatase >3x ULN.
- Creatinine levels >1.2x ULN will be repeated; subjects with creatinine re-test values remaining above this level will be excluded.
- Bilirubin levels >1.5x ULN will be repeated to determine trends; subjects with bilirubin increasing over time will be excluded.
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 |
|---|---|---|
| CobenfyParticipants receive Cobenfy maintenance (100 mg xanomeline + 20 mg trospium twice daily) during the inpatient protocol, prior to IV cocaine self-administration. | Drug | Cobenfy Maintenance |
| PlaceboParticipants receive matching placebo maintenance during the inpatient protocol prior to cocaine self-administration sessions. | Drug | Placebo Maintenance |
Primary outcome
Cocaine Self-Administration Choice Behavior
Time frame: During Inpatient Experimental Sessions (Days 6-11)
Number of cocaine choices selected during progressive-ratio cocaine-versus-money choice sessions following Cobenfy or placebo maintenance.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cobenfy in people with Cocaine Use Disorder (CUD), run by Joshua A. Lile, Ph.D. 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 3 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 18 Aug 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua Lile (8593236034, jalile2@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cocaine Self-Administration Choice Behavior (time frame: During Inpatient Experimental Sessions (Days 6-11)). 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 18 Aug 2026.