Pioglitazone for Heroin and for Nicotine Dependence

• ClinicalTrials.gov Identifier: NCT01395797
• Recruitment Status: Terminated
• First Posted: July 18, 2011
• Results First Posted: July 13, 2017
• Last Update Posted: July 13, 2017
• Sponsor: New York State Psychiatric Institute
• Collaborators: National Institute on Drug Abuse (NIDA); Omeros Corporation
• Information provided by (Responsible Party): New York State Psychiatric Institute

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Heroin Dependence; Nicotine Dependence	Drug: PIO; Drug: Placebo	Phase 1; Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Effects of Pioglitazone, a PPARγ Agonist, on the Abuse Liability of Heroin and of Nicotine
• Study Start Date: March 2011
• Actual Primary Completion Date: April 2014
• Actual Study Completion Date: June 2014

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo - Heroin; Participants will be maintained on 0 mg of Pioglitazone (PIO) prior to sessions assessing the abuse liability of heroin.	Drug: Placebo; Placebo; Other Name: Actos
Experimental: PIO low dose - Heroin; Participants will be maintained on 15 mg of PIO prior to sessions assessing the abuse liability of heroin.	Drug: PIO; 0, 15, and 45 mg per day.; Other Name: Actos
Experimental: PIO high dose - Heroin; Participants will be maintained on 45 mg of PIO prior to sessions assessing the abuse liability of heroin.	Drug: PIO; 0, 15, and 45 mg per day.; Other Name: Actos
Placebo Comparator: Placebo - Nicotine; Participants will be maintained on 0 mg of PIO prior to sessions assessing the abuse liability of nicotine.	Drug: PIO; 0, 15, and 45 mg per day.; Other Name: Actos
Experimental: PIO Low Dose - Nicotine; Participants will be maintained on 15 mg of PIO prior to sessions assessing the abuse liability of nicotine	Drug: PIO; 0, 15, and 45 mg per day.; Other Name: Actos
Experimental: PIO High Dose - Nicotine; Participants will be maintained on 45 mg of PIO prior to sessions assessing the abuse liability of nicotine	Drug: PIO; 0, 15, and 45 mg per day.; Other Name: Actos

Outcome Measures

Primary Outcome Measures :

1. Drug's Break Point [ Time Frame: Following 2 weeks of Pioglitazone (PIO) maintenance. ]
   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.

Secondary Outcome Measures :

1. Measures of Subjective Drug Effects Most Commonly Indicative of Abuse Liability. [ Time Frame: Following 2 weeks of Pioglitazone (PIO) maintenance. ]
   Visual analog scale ratings of "Liking" reported by the participant will be the primary endpoint (0-100 mm, 0=Not at all, 100=Extremely).

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, New York

New York State Psychiatric Institute

New York, New York, United States, 10032

Sponsors and Collaborators

New York State Psychiatric Institute

National Institute on Drug Abuse (NIDA)

Omeros Corporation

Investigators

• Principal Investigator: Sandra D. Comer, MD; Columbia University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Martinez S, Jones JD, Vadhan NP, Brandt L, Comer SD, Bisaga A. The acute and repeated effects of cigarette smoking and smoking-related cues on impulsivity. Drug Alcohol Rev. 2021 Jul;40(5):864-868. doi: 10.1111/dar.13206. Epub 2020 Nov 2.

• Responsible Party: New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT01395797
• Other Study ID Numbers: 6255; R01DA031022 ( U.S. NIH Grant/Contract )
• First Posted: July 18, 2011
• Results First Posted: July 13, 2017
• Last Update Posted: July 13, 2017
• Last Verified: July 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Data will be presented at conferences and published in a peer-reviewed journal.

Additional relevant MeSH terms:

Tobacco Use Disorder; Heroin Dependence; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Pioglitazone; Hypoglycemic Agents; Physiological Effects of Drugs