The Impact of Cobenfy Maintenance on Cocaine's Effects
Joshua A. Lile, Ph.D.
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. 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.
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- No
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 oophorec…
Interventions
- DrugCobenfy
Participants receive Cobenfy maintenance (100 mg xanomeline + 20 mg trospium twice daily) during the inpatient protocol, prior to IV cocaine self-administration.
- DrugPlacebo
Participants receive matching placebo maintenance during the inpatient protocol prior to cocaine self-administration sessions.
Location
- Psychopharmacology of Addiction LaboratoryLexington, Kentucky