The Impact of Cobenfy Maintenance on Cocaine's Effects

Conditions

• Cocaine Use Disorder (CUD)

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• Cobenfy — DRUG
  Participants receive Cobenfy maintenance (100 mg xanomeline + 20 mg trospium twice daily) during the inpatient protocol, prior to IV cocaine self-administration.
• Placebo — DRUG
  Participants receive matching placebo maintenance during the inpatient protocol prior to cocaine self-administration sessions.

Study Details

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.

Key Dates

Start date

Aug 1, 2026

Status verified

May 2026

Primary completion

Jun 30, 2032

Completion

Jun 30, 2032

Study Design

Enrollment

32 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cobenfy Maintenance
  Participants receive Cobenfy maintenance (100 mg xanomeline + 20 mg trospium twice daily) during the inpatient protocol, followed by IV cocaine self-administration and behavioral assessment sessions.
• Placebo Comparator: Placebo Maintenance
  Participants receive placebo maintenance during the inpatient protocol, followed by IV cocaine self-administration and behavioral assessment sessions.

Primary Outcome Measure

Cocaine Self-Administration Choice Behavior [ Time Frame: During Inpatient Experimental Sessions (Days 6-11) ]

Central Contacts

• Joshua Lile
  8593236034
  [email protected]

Locations (1)

Find similar trials in Lexington, KY