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Could a schizophrenia drug curb Cocaine's grip?

NCT ID NCT07624227

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times

Summary

This trial investigates whether Cobenfy, a medication typically used for schizophrenia, can reduce the rewarding effects of cocaine in people with cocaine use disorder. Over an 11-day inpatient stay, participants receive either Cobenfy or a placebo twice daily, then take part in sessions where they can choose between cocaine and money. The study aims to see if Cobenfy makes cocaine less appealing and to check the safety of combining the two drugs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cobenfy (xanomeline + trospium)
What this could lead to
If successful, Cobenfy could become a medication to help people with cocaine use disorder reduce their cocaine use by blocking its rewarding effects.
What could go wrong
This is an early-phase trial with only 32 participants, so results may not apply broadly. Combining Cobenfy with cocaine may cause unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Jun 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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. * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Psychopharmacology of Addiction Laboratory

    RECRUITING

    Lexington, Kentucky, 40502, United States

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