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Pioglitazone for Heroin and for Nicotine Dependence

This study has been terminated.
(The funding period ended.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01395797
First Posted: July 18, 2011
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute on Drug Abuse (NIDA)
Omeros Corporation
Information provided by (Responsible Party):
New York State Psychiatric Institute
  Purpose
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 Intervention Phase
Heroin Dependence Nicotine Dependence Drug: PIO Drug: Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • 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:
  • 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).


Enrollment: 82
Study Start Date: March 2011
Study Completion Date: June 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395797


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

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01395797     History of Changes
Other Study ID Numbers: 6255
R01DA031022 ( U.S. NIH Grant/Contract )
First Submitted: July 13, 2011
First Posted: July 18, 2011
Results First Submitted: August 31, 2015
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
Nicotine
Pioglitazone
Heroin
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents


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