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Pioglitazone for Heroin and for Nicotine Dependence

Primary Purpose

Heroin Dependence, Nicotine Dependence

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PIO
Placebo
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Heroin Dependence

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo - Heroin

PIO low dose - Heroin

PIO high dose - Heroin

Placebo - Nicotine

PIO Low Dose - Nicotine

PIO High Dose - Nicotine

Arm Description

Participants will be maintained on 0 mg of Pioglitazone (PIO) prior to sessions assessing the abuse liability of heroin.

Participants will be maintained on 15 mg of PIO prior to sessions assessing the abuse liability of heroin.

Participants will be maintained on 45 mg of PIO prior to sessions assessing the abuse liability of heroin.

Participants will be maintained on 0 mg of PIO prior to sessions assessing the abuse liability of nicotine.

Participants will be maintained on 15 mg of PIO prior to sessions assessing the abuse liability of nicotine

Participants will be maintained on 45 mg of PIO prior to sessions assessing the abuse liability of nicotine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
July 13, 2011
Last Updated
July 11, 2017
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA), Omeros Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01395797
Brief Title
Pioglitazone for Heroin and for Nicotine Dependence
Official Title
Effects of Pioglitazone, a PPARγ Agonist, on the Abuse Liability of Heroin and of Nicotine
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
The funding period ended.
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA), Omeros Corporation

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heroin Dependence, Nicotine Dependence

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo - Heroin
Arm Type
Placebo Comparator
Arm Description
Participants will be maintained on 0 mg of Pioglitazone (PIO) prior to sessions assessing the abuse liability of heroin.
Arm Title
PIO low dose - Heroin
Arm Type
Experimental
Arm Description
Participants will be maintained on 15 mg of PIO prior to sessions assessing the abuse liability of heroin.
Arm Title
PIO high dose - Heroin
Arm Type
Experimental
Arm Description
Participants will be maintained on 45 mg of PIO prior to sessions assessing the abuse liability of heroin.
Arm Title
Placebo - Nicotine
Arm Type
Placebo Comparator
Arm Description
Participants will be maintained on 0 mg of PIO prior to sessions assessing the abuse liability of nicotine.
Arm Title
PIO Low Dose - Nicotine
Arm Type
Experimental
Arm Description
Participants will be maintained on 15 mg of PIO prior to sessions assessing the abuse liability of nicotine
Arm Title
PIO High Dose - Nicotine
Arm Type
Experimental
Arm Description
Participants will be maintained on 45 mg of PIO prior to sessions assessing the abuse liability of nicotine
Intervention Type
Drug
Intervention Name(s)
PIO
Other Intervention Name(s)
Actos
Intervention Description
0, 15, and 45 mg per day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Actos
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Drug's Break Point
Description
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.
Time Frame
Following 2 weeks of Pioglitazone (PIO) maintenance.
Secondary Outcome Measure Information:
Title
Measures of Subjective Drug Effects Most Commonly Indicative of Abuse Liability.
Description
Visual analog scale ratings of "Liking" reported by the participant will be the primary endpoint (0-100 mm, 0=Not at all, 100=Extremely).
Time Frame
Following 2 weeks of Pioglitazone (PIO) maintenance.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra D. Comer, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be presented at conferences and published in a peer-reviewed journal.
Citations:
PubMed Identifier
33140460
Citation
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.
Results Reference
derived

Learn more about this trial

Pioglitazone for Heroin and for Nicotine Dependence

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