Heroin DependencePhase 1/2NCT01395797
Pioglitazone for Heroin and for Nicotine Dependence
A Phase 1/2 study testing PIO in people with Heroin Dependence and Nicotine Dependence, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Heroin Dependence, Nicotine Dependence
- What is being tested?
- PIO
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jun 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 21-55 years of age
- Physically healthy
- Able to perform study procedures
Who cannot join
- Pregnancy
- Physical dependence on any other drugs besides caffeine, heroin and nicotine
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Effects of Pioglitazone, a PPARγ Agonist, on the Abuse Liability of Heroin and of Nicotine
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.
- Conditions
- Heroin Dependence, Nicotine Dependence
- Being tested
- PIO, Placebo
- Medical subject headings
- Heroin Dependence, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIODrug
Also called Actos
0, 15, and 45 mg per day.
PlaceboDrug
Also called Actos
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo - Heroin | Placebo comparator | Participants will be maintained on 0 mg of Pioglitazone (PIO) prior to sessions assessing the abuse liability of heroin. Receives: 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. Receives: 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. Receives: Drug: PIO |
| Placebo - Nicotine | Placebo comparator | Participants will be maintained on 0 mg of PIO prior to sessions assessing the abuse liability of nicotine. Receives: 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 Receives: 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 Receives: Drug: PIO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Following 2 weeks of Pioglitazone (PIO) maintenance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2014
- Study completionJun 2014
Why it stopped: The funding period ended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heroin DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Omeros Corporation
- Responsible party
- Sponsor
- Investigators
- Sandra D. Comer, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395797
- Sponsor's protocol ID
- 6255
- Other IDs
- R01DA031022
- Status last verified
- Jul 2017
- First submitted
- 13 Jul 2011
- Last updated
- 13 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will be presented at conferences and published in a peer-reviewed journal.
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pioglitazone, a PPARγ Agonist, on the Abuse Liability of Heroin and of Nicotine
- ClinicalTrials.gov ID
- NCT01395797
- Acronym / sponsor ID
- 6255
- Conditions
- Heroin Dependence, Nicotine Dependence
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The funding period ended.
- Enrolment
- 82 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Omeros Corporation
- Study start
- Mar 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 18 Jul 2011 (estimated)
- Results
- Posted 13 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo - Heroin | Placebo comparator | Drug: PlaceboParticipants will be maintained on 0 mg of Pioglitazone (PIO) prior to sessions assessing the abuse liability of heroin. |
| PIO low dose - Heroin | Experimental | Drug: PIOParticipants will be maintained on 15 mg of PIO prior to sessions assessing the abuse liability of heroin. |
| PIO high dose - Heroin | Experimental | Drug: PIOParticipants will be maintained on 45 mg of PIO prior to sessions assessing the abuse liability of heroin. |
| Placebo - Nicotine | Placebo comparator | Drug: PIOParticipants will be maintained on 0 mg of PIO prior to sessions assessing the abuse liability of nicotine. |
| PIO Low Dose - Nicotine | Experimental | Drug: PIOParticipants will be maintained on 15 mg of PIO prior to sessions assessing the abuse liability of nicotine |
| PIO High Dose - Nicotine | Experimental | Drug: PIOParticipants will be maintained on 45 mg of PIO prior to sessions assessing the abuse liability of nicotine |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 21-55 years of age
- Physically healthy
- Able to perform study procedures
Key exclusion criteria (2 listed)
- Pregnancy
- Physical dependence on any other drugs besides caffeine, heroin and nicotine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIOAlso: Actos0, 15, and 45 mg per day. | Drug | PIO High Dose - Nicotine, PIO Low Dose - Nicotine, PIO high dose - Heroin, PIO low dose - Heroin, Placebo - Nicotine |
| PlaceboAlso: ActosPlacebo | Drug | Placebo - Heroin |
Primary outcome
Drug's Break Point
Time frame: Following 2 weeks of Pioglitazone (PIO) maintenance.
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.
1 secondary outcome
Measures of Subjective Drug Effects Most Commonly Indicative of Abuse Liability.
Time frame: Following 2 weeks of Pioglitazone (PIO) maintenance.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33140460Martinez 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.
- Individual participant dataSharing planned: Yes. Data will be presented at conferences and published in a peer-reviewed journal.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra D. Comer, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PIO in people with Heroin Dependence and Nicotine Dependence, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug's Break Point (time frame: Following 2 weeks of Pioglitazone (PIO) maintenance.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01395797, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2017.