Using pioglitazone with therapy to prevent cocaine relapse
Pioglitazone as an Adjunct to Cognitive-Behavioral Therapy for Cocaine Relapse Prevention
This study is testing if adding the medication pioglitazone to therapy can help people recovering from cocaine addiction avoid relapse better than therapy alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04843046 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of pioglitazone, a medication that activates the PPAR pathway, as an adjunct to cognitive behavioral therapy (CBT) for individuals recovering from cocaine use disorder. The aim is to enhance the relapse-prevention effects of CBT, which is known to improve cognitive control functions that are often impaired in chronic cocaine users. Participants will undergo a 5-day inpatient detoxification program and will be monitored for their response to the combined treatment approach. The study seeks to address the high rates of relapse following traditional CBT by integrating a pharmacological intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who meet the diagnostic criteria for cocaine use disorder and have recently used cocaine.
Not a fit: Patients who are not psychiatrically stable or physically healthy, or who are pregnant or lactating, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce relapse rates in individuals recovering from cocaine use disorder.
How similar studies have performed: While the combination of pharmacological and behavioral therapies is a growing area of interest, this specific approach using pioglitazone with CBT is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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)
Where this trial is running
Houston, Texas
- UTHealth Center for Neurobehavioral Research on Addiction — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Joy M Schmitz, PhD — UT Houston
- Study coordinator: Joy M Schmitz, PhD
- Email: Joy.M.Schmitz@uth.tmc.edu
- Phone: 713-486-2867
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.