The Impact of Cobenfy Maintenance on Cocaine's Effects
ConditionCocaine Use Disorder (CUD)
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorJoshua A. Lile, Ph.D.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Cobenfy
- Placebo
Treatment groups
32 Participants
are divided into 2 treatment groupsSponsors and collaborators
Joshua A. Lile, Ph.D.
Lead sponsor
University of Kentucky
Sponsor institution
Source ClinicalTrials.gov