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TerminatedNCT01395797Updated Jul 13, 2017Results posted

Pioglitazone for Heroin and for Nicotine Dependence

A Phase 1/2 interventional study of PIO and Placebo in Heroin Dependence and Nicotine Dependence, sponsored by New York State Psychiatric Institute. Terminated at 1 site in United States. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-13.

Sponsored by New York State Psychiatric Institute · Phase 1/2, Interventional, and Basic science

Why this study was terminated
The funding period ended.
Phase
Phase 1/2
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
21 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Heroin Dependence
  • Nicotine Dependence
03

In context

Heroin Dependence

90 studies on the registry are indexed under Heroin Dependence; 1 is open to participants now.

This study's enrollment of 82 is close to the median of 87 across 57 interventional studies indexed under Heroin Dependence.

Browse Heroin Dependence studies →

Lead sponsor

New York State Psychiatric Institute is the lead sponsor of 435 studies on the registry; 27 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 45 (88%) have results posted.

Browse New York State Psychiatric Institute studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 21-55 years of age
  • Physically healthy
  • Able to perform study procedures

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Physical dependence on any other drugs besides caffeine, heroin and nicotine
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
82 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • Placebo comparator
    Placebo - Nicotine

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

    Drug: PIO

  • 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

  • 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

Interventions

  • DrugPIO

    0, 15, and 45 mg per day.

    Also known as: Actos

  • DrugPlacebo

    Placebo

    Also known as: Actos

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Following 2 weeks of Pioglitazone (PIO) maintenance.

Secondary outcomes

  1. 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).

    Time frame: Following 2 weeks of Pioglitazone (PIO) maintenance.

07

Results

Posted Jul 13, 2017

Participant flow

Participant flow — Overall Study
MilestonePlacebo - HeroinPio Low Dose - HeroinPio High Dose - HeroinPlacebo - NicotinePio Low Dose - NicotinePio High Dose - Nicotine
Started1941815917
Completed1631413714
Not completed314223

Outcome measures

PrimaryDrug'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.

Time frame:
Following 2 weeks of Pioglitazone (PIO) maintenance.
Reported as:
Mean · Mouse clicks
Drug's Break Point
Mouse clicksPlacebo - HeroinPio Low Dose- HeroinPio High Dose - HeroinPlacebo - NicotinePio Low Dose- NicotinePio High Dose - Nicotine
Drug's Break Point1037 ± 17631200 ± 2722014 ± 2835568 ± 652722 ± 823960 ± 1004
SecondaryMeasures 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).

Time frame:
Following 2 weeks of Pioglitazone (PIO) maintenance.
Reported as:
Mean · units on a scale
Measures of Subjective Drug Effects Most Commonly Indicative of Abuse Liability.
units on a scalePlacebo - HeroinPio Low Dose- HeroinPio High Dose - HeroinPlacebo - NicotinePio Low Dose- NicotinePio High Dose - Nicotine
Measures of Subjective Drug Effects Most Commonly Indicative of Abuse Liability.24 ± 1315 ± 919 ± 659 ± 968 ± 1262.5 ± 10

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo - Heroin—0/19 (0%)0/19 (0%)
Pio Low Dose - Heroin—0/4 (0%)0/4 (0%)
Pio High Dose - Heroin—0/18 (0%)0/18 (0%)
Placebo - Nicotine—0/15 (0%)0/15 (0%)
Pio Low Dose - Nicotine—0/9 (0%)0/9 (0%)
Pio High Dose - Nicotine—0/17 (0%)0/17 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Placebo - HeroinPio Low Dose - HeroinPio High Dose - HeroinPlacebo - NicotinePio Low Dose - NicotinePio High Dose - NicotineTotal
<=18 years0000000
Between 18 and 65 years194181591782
>=65 years0000000
Sex: Female, Male
Sex: Female, Male(Participants)Placebo - HeroinPio Low Dose - HeroinPio High Dose - HeroinPlacebo - NicotinePio Low Dose - NicotinePio High Dose - NicotineTotal
Female0022127
Male194161381575
Region of Enrollment
Region of Enrollment(participants)Placebo - HeroinPio Low Dose - HeroinPio High Dose - HeroinPlacebo - NicotinePio Low Dose - NicotinePio High Dose - NicotineTotal
United States194181591782
08

Study locations

1 site
  • New York State Psychiatric Institute
    New York, New York 10032, United States
09

References and documents

Publications

  • 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. PubMed 33140460 ↗

Individual participant data

Plan to share: Yes — Data will be presented at conferences and published in a peer-reviewed journal.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01395797
Lead sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA), Omeros Corporation
Responsible party
Sponsor
First posted
Jul 18, 2011
Start date
Mar 2011
Primary completion
Apr 2014
Completion
Jun 2014
Results posted
Jul 13, 2017
Last update
Jul 13, 2017

Study contacts

Sandra D. Comer, MD
principal investigator · Columbia University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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