Pioglitazone for Heroin and for Nicotine Dependence

Nicotine Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01395797
• Other study ID #: 6255
• Secondary ID: R01DA031022
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: July 13, 2011
• Last updated: July 11, 2017
• Start date: March 2011
• Est. completion date: June 2014

Study information

• Verified date: July 2017
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 82
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

• 21-55 years of age

• Physically healthy

• Able to perform study procedures

Exclusion Criteria:

• Pregnancy

• Physical dependence on any other drugs besides caffeine, heroin and nicotine

Related Conditions & MeSH terms

• Heroin Dependence
• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Drug:
• PIO
0, 15, and 45 mg per day.
• Placebo
Placebo

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Drug Abuse (NIDA), Omeros Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug's Break Point	Number of operant responses (mouse clicks) participants were willing to provide in order to receive the drug under investigation (heroin or nicotine). The Breakpoint is the point at which participants stopped responding for the drug, i.e., the total number of clicks they were willing to provide in order to receive the drug.	Following 2 weeks of Pioglitazone (PIO) maintenance.
Secondary	Measures of Subjective Drug Effects Most Commonly Indicative of Abuse Liability.	Visual analog scale ratings of "Liking" reported by the participant will be the primary endpoint (0-100 mm, 0=Not at all, 100=Extremely).	Following 2 weeks of Pioglitazone (PIO) maintenance.