Pioglitazone for Heroin and for Nicotine Dependence

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by New York State Psychiatric Institute
Sponsor:
Collaborators:
Omeros Corporation
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01395797
First received: July 13, 2011
Last updated: November 4, 2013
Last verified: November 2013
  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: Pioglitazone
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:
  • Number of drug choices [ Time Frame: Repeatedly during the 3-week study ] [ Designated as safety issue: No ]
    Participants will be given the choice to self-administer drug (heroin or cigarettes) and the number of drug choices (range: 0-5) per day will be used as the primary outcome variable.


Secondary Outcome Measures:
  • Subjective drug, mood, and physiological effects [ Time Frame: Repeatedly during the 3-weeks study ] [ Designated as safety issue: No ]
    Visual analog scale ratings will be the primary endpoint (0-100 mm, 0=Not at all, 100=Extremely)


Estimated Enrollment: 120
Study Start Date: March 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo - Heroin
Control condition for active arms.
Drug: Placebo
Placebo - Heroin
Active Comparator: Pio low dose - Heroin
Low dose pio comparator.
Drug: Pioglitazone
0, 15, and 45 mg per day.
Other Name: Actos
Active Comparator: Pio high dose - Heroin
High dose pio comparator.
Drug: Pioglitazone
0, 15, and 45 mg per day.
Other Name: Actos
Placebo Comparator: Placebo - Nicotine
Control condition for active arms.
Drug: Pioglitazone
0, 15, and 45 mg per day.
Other Name: Actos
Active Comparator: Pio Low Dose - Nicotine
Low dose pio comparator.
Drug: Pioglitazone
0, 15, and 45 mg per day.
Other Name: Actos
Active Comparator: Pio High Dose - Nicotine
High dose pio comparator.
Drug: Pioglitazone
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

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395797

Contacts
Contact: Gabriela Madera, BS 212-543-5319 maderag@pi.cpmc.columbia.edu
Contact: Jessica Fogel, BS 212-543-5319 fogelje@pi.cpmc.columbia.edu

Locations
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Gabriela Madera, BS    212-543-5319    maderag@pi.cpmc.columbia.edu   
Contact: Jessica Fogel, BS    212-543-5319    fogelje@pi.cpmc.columbia.edu   
Sponsors and Collaborators
New York State Psychiatric Institute
Omeros Corporation
Investigators
Principal Investigator: Sandra D. Comer, MD Columbia University
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01395797     History of Changes
Other Study ID Numbers: 6255, R01DA031022
Study First Received: July 13, 2011
Last Updated: November 4, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heroin Dependence
Tobacco Use Disorder
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Heroin
Nicotine polacrilex
Nicotine
Pioglitazone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics
Ganglionic Stimulants
Autonomic Agents
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Hypoglycemic Agents

ClinicalTrials.gov processed this record on July 24, 2014