NCT01395797

Pioglitazone for Heroin and for Nicotine Dependence

Effects of Pioglitazone, a PPARγ Agonist, on the Abuse Liability of Heroin and of Nicotine

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The goal of the proposed research is to improve the effectiveness of treatments for opioid and for nicotine dependence by testing a novel pharmacological strategy. Specifically, pioglitazone, a peroxisome proliferator-activated gamma receptor (PPARγ) agonist, will be used as an adjunct to agonist-based treatment.

Detailed description

Although treatments for opioid and for nicotine dependence exist, these medications are not universally effective as many patients are unable to stop using or relapse rapidly, suggesting that treatment with a single agent alone is insufficient to facilitate cessation of use in many patients. Targeting additional pathways that may contribute to the maintenance of drug-taking behaviors or relapse may be a more effective strategy to treat individuals resistant to first-line approaches.

Conditions

• Heroin Dependence
• Nicotine Dependence

Interventions

Type	Name	Description
DRUG	PIO	0, 15, and 45 mg per day.
DRUG	Placebo	Placebo

Timeline

• Start date: 2011-03-01
• Primary completion: 2014-04-01
• Completion: 2014-06-01
• First posted: 2011-07-18
• Last updated: 2017-07-13
• Results posted: 2017-07-13

Locations

1 site across 1 country: United States