Status:
RECRUITING
Pioglitazone as an Adjunct to Cognitive-Behavioral Therapy for Cocaine Relapse Prevention
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Use Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to see how well pioglitazone, when used with cognitive behavioral therapy, works at helping people who have recently stopped using cocaine to continue to not use cocaine.
Detailed Description
Over one million American adults suffer from cocaine use disorder (CUD) with recent trends showing an increase in cocaine-related deaths since 2010. For the chronic cocaine user, significant changes i...
Eligibility Criteria
Inclusion
- 18 to 65 years old
- meet DSM 5 diagnostic criteria for cocaine use disorder
- report recent cocaine use, verified by at least one positive urine drug screen for the cocaine metabolite, benzoylecgonine, during intake
- be judged by the medical staff to be psychiatrically stable and physically healthy
- for females, be using an effective form of birth control (e.g., barrier, IUD, or sterilization) and not be pregnant as determined by a serum pregnancy test at screening and negative urine pregnancy test at intake prior to first dose of investigational drug (test will be repeated weekly to ensure that female patients do not continue in the study if pregnant) or lactating
- be willing to be admitted to a 5-day inpatient detoxification program at The Right Step Houston
- be able to understand the consent form and provide written informed consent
- be able to provide the names of at least 2 persons who can consistently locate their whereabouts
Exclusion
- have an acute medical or psychiatric disorder that would, in the judgment of the study physician, make participation difficult or unsafe
- have suicidal or homicidal ideation that requires immediate attention
- have another current (≥ moderate) substance use disorder aside from alcohol, nicotine, or marijuana
- have a medical condition contraindicating PIO pharmacotherapy (e.g., drug- or insulin-dependent diabetes, congestive heart failure, edema, clinical significant liver disease, hypoglycemia, history of bladder cancer) or be taking medications that would adversely interact with PIO (e.g., CYP2C8 inhibitors or inducers, antihyperglycemic medications)
- be concurrently enrolled in other addiction treatment services aside from smoking cessation
- if female, be currently pregnant, breastfeeding, or planning on conception
- have conditions of probation or parole requiring reports of drug use to officers of the court
- be unable to read, write, or speak English
- be homeless (live on the street)
- have medical contraindications to MRI/DTI scans (e.g., history of pacemaker, metal implants, or welding/metal work without protective eyewear)
Key Trial Info
Start Date :
August 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04843046
Start Date
August 23 2021
End Date
February 1 2026
Last Update
September 12 2025
Active Locations (1)
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1
UTHealth Center for Neurobehavioral Research on Addiction
Houston, Texas, United States, 77054