Cobenfy Maintenance to See If It Affects Cocaine Effects in Cocaine Use Disorder
Official title: The Impact of Cobenfy Maintenance on Cocaine's Effects
Run by University of Kentucky · NCT07624227 · Data updated 2026-11-12
This study tests whether Cobenfy can change how cocaine makes people feel and helps see if it’s safe to use with cocaine in adults with cocaine use disorder.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 32 (estimated) |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Status | Recruiting |
| Started | August 1, 2026 |
| Main results expected | June 30, 2032 |
| Study ends | June 30, 2032 |
| Registry record updated | August 18, 2026 |
| Trial ID | NCT07624227 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with current cocaine use disorder who test positive for recent cocaine use and are English-speaking.
✕Probably not a fit
Individuals without cocaine use disorder, those not meeting inclusion criteria, or those with unsafe screening results may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study tests Cobenfy versus a placebo in adults with cocaine use disorder. Participants undergo an 11-day inpatient stay and take either Cobenfy or a placebo twice daily. Experimental sessions assess how Cobenfy influences responses to cocaine and cocaine self-administration, collecting safety and tolerability data. The trial aims to determine whether Cobenfy can blunt cocaine effects and reduce use, while monitoring adverse events.
Why it matters
Potential benefit: If successful, Cobenfy could help lessen cocaine's effects and improve safety for people with cocaine use disorder.
How similar studies have gone: Previous studies in this area have explored pharmacologic blockers with mixed results; this trial tests a similar approach in a well-defined inpatient setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Psychopharmacology of Addiction Laboratory
Lexington, Kentucky, United States Recruiting
Study contacts
- Study coordinator: Joshua Lile
- Email: jalile2@uky.edu
- Phone: 8593236034
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Potassium Channel Blockade and Working Memory in Cocaine Use Disorder
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Contingency Management with Deep TMS for Cocaine Use Disorder
This study tests whether a combination of contingency management and deep TMS helps people with cocaine use disorder who haven’t responded to initial treatments.
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Smartphone app training to strengthen inhibition around alcohol or cocaine in teens and young adults
This project will test a smartphone app that delivers alcohol- or cocaine-specific inhibition training to 14–35-year-olds in treatment for substance use disorder to see if the app is practical to use and affects drinking or drug use.
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HD-tDCS during CBT for Cocaine Use Disorder
This study tests whether adding high-definition transcranial direct current stimulation to cognitive behavioral therapy helps adults with cocaine use disorder see if CBT works better.
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Imaging Brain Mitochondrial Complex-I in Cocaine Use Disorder
This study uses a PET scan with [F-18]BCPP-EF to see how mitochondrial Complex-I activity in the brain differs between people with cocaine use disorder and healthy controls.
-
Mild electrical brain stimulation (tDCS) with cognitive training to reduce cocaine cravings.
This trial will test whether brief sessions of mild electrical brain stimulation (tDCS) combined with cognitive reappraisal training can lower craving in adults receiving inpatient treatment for cocaine use disorder.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.