NCT01395797

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 18, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

July 13, 2017

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

3.1 years

First QC Date

July 13, 2011

Results QC Date

August 31, 2015

Last Update Submit

July 11, 2017

Conditions

Heroin DependenceNicotine Dependence

Outcome Measures

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.

    Following 2 weeks of Pioglitazone (PIO) maintenance.

Secondary Outcomes (1)

  • Measures of Subjective Drug Effects Most Commonly Indicative of Abuse Liability.

    Following 2 weeks of Pioglitazone (PIO) maintenance.

Study Arms (6)

Placebo - Heroin

PLACEBO COMPARATOR

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

Drug: Placebo

PIO low dose - Heroin

EXPERIMENTAL

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

Drug: PIO

PIO high dose - Heroin

EXPERIMENTAL

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

Drug: PIO

Placebo - Nicotine

PLACEBO COMPARATOR

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

Drug: PIO

PIO Low Dose - Nicotine

EXPERIMENTAL

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

Drug: PIO

PIO High Dose - Nicotine

EXPERIMENTAL

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

Drug: PIO

Interventions

PIODRUG

0, 15, and 45 mg per day.

Also known as: Actos
PIO High Dose - NicotinePIO Low Dose - NicotinePIO high dose - HeroinPIO low dose - HeroinPlacebo - Nicotine
PlaceboDRUG

Placebo

Also known as: Actos
Placebo - Heroin

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • Physically healthy
  • Able to perform study procedures

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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.

    PMID: 33140460DERIVED

MeSH Terms

Conditions

Heroin DependenceTobacco Use Disorder

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Opioid-Related DisordersNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Sandra Comer PhD
Organization
New York State Psychiatric Institute
sdc10@columbia.edu
646 774-6146

Study Officials

  • Sandra D. Comer, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2011

First Posted

July 18, 2011

Study Start

March 1, 2011

Primary Completion

April 1, 2014

Study Completion

June 1, 2014

Last Updated

July 13, 2017

Results First Posted

July 13, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will share

Data will be presented at conferences and published in a peer-reviewed journal.

Locations

US(1)