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Cobenfy for Cocaine Use Disorder

This study is investigating if Cobenfy (a combination of 100 mg xanomeline and 20 mg trospium) can reduce the effects of cocaine in people with cocaine use disorder (CUD). Researchers will compare Cobenfy to a placebo (an inactive substance) to see if it's safe and effective at blocking cocaine's effects. You may be able to join if you are 18-60 years old, have CUD, and have used cocaine recently. The main goal is to see how Cobenfy affects your choices when given cocaine during the study. The study is currently unclear on its recruitment status.

Study design
This study is interventional and plans to enroll 32 participants. It compares Cobenfy to a placebo to understand its impact.
What's involved
You would participate in an 11-day inpatient trial, taking either Cobenfy or placebo twice daily. You would also take part in experimental sessions to test the effects of the study drug on your response to cocaine.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, cocaine self-administration choice behavior, is measured during inpatient experimental sessions (Days 6-11).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07624227

The Impact of Cobenfy Maintenance on Cocaine's Effects

Recruiting
PHASE1Ages 18–60InterventionalTreatment
Joshua A. Lile, Ph.D.
~32 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:CobenfyPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cocaine Self-Administration Choice Behavior
Measured over During Inpatient Experimental Sessions (Days 6-11)

Conditions

Cocaine Use Disorder (CUD)

Explore related trials

Cocaine Use Disorder

NCT07624227

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Psychopharmacology of Addiction Laboratory

    Lexington, Kentuckystudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Joshua Lile
[email protected]
8593236034
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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.

Exclusion

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.
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.
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.

What this trial measures

  • Cocaine Self-Administration Choice BehaviorDuring Inpatient Experimental Sessions (Days 6-11)

    Number of cocaine choices selected during progressive-ratio cocaine-versus-money choice sessions following Cobenfy or placebo maintenance.