NCT02774343

PPARγ Agonist Treatment for Cocaine Dependence

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to determine whether a medication called pioglitazone (trade name Actos) can reduce behavioral problems associated with cocaine use, improve brain structural changes associated with cocaine use and reduce cocaine craving and drug use in cocaine dependent patients.

Conditions

• Cocaine Use Disorder
• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	Pioglitazone	Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.
DRUG	Placebo	Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.
BEHAVIORAL	Therapy	Cognitive-behavioral therapy 1 hour per week
BEHAVIORAL	Contingency Management	Prize-based contingency management for attendance

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2016-05-17
• Last updated: 2018-04-26
• Results posted: 2018-04-26

Locations

1 site across 1 country: United States