MedTrace Logo

The Impact of Cobenfy Maintenance on Cocaine's Effects

NCT07624227 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-08-18

No results posted yet for this study

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.

Conditions

  • Cocaine Use Disorder (CUD)

Interventions

DRUG

Cobenfy

Participants receive Cobenfy maintenance (100 mg xanomeline + 20 mg trospium twice daily) during the inpatient protocol, prior to IV cocaine self-administration.

DRUG

Placebo

Participants receive matching placebo maintenance during the inpatient protocol prior to cocaine self-administration sessions.

Sponsors & Collaborators

  • Joshua A. Lile, Ph.D.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2032-06-30
Completion
2032-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07624227 on ClinicalTrials.gov