Pioglitazone for Heroin and for Nicotine Dependence
This study is currently recruiting participants.
Verified December 2012 by New York State Psychiatric Institute
Sponsor:
New York State Psychiatric Institute
Collaborators:
Omeros Corporation
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01395797
First received: July 13, 2011
Last updated: December 18, 2012
Last verified: December 2012
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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:
MedlinePlus related topics:
Heroin
Drug Information available for:
Nicotine tartrate
Nicotine polacrilex
Pioglitazone
Pioglitazone hydrochloride
U.S. FDA Resources
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
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: | December 18, 2012 |
| 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 May 23, 2013