Opioid AbusePhase 2NCT01395784
Effects of Pioglitazone, a PPARgamma Receptor Agonist, on the Abuse Liability of Oxycodone
A Phase 2 study testing pioglitazone in people with Opioid Abuse, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The ability of pioglitazone (PIO) to alter the effects of opioids in humans has not been characterized in a controlled laboratory setting. Accordingly, the proposed investigation seeks to examine the effects of PIO on oxycodone, one of the most commonly used and abused opioid drugs in the U.S. (Davis et al., 2003). Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Abuse
- What is being tested?
- pioglitazone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Apr 2014
- Phase
- Phase 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recreational use of prescription opioids at least once per month within the past year
- No current major mood, psychotic, or anxiety disorder
- Physically healthy
- aspartate aminotransferase (AST) or alanine aminotransferase (ALT) within normal limits
- Able to perform study procedures 6.21-45 years of age
- 7.Blood glucose concentration between 70-145 mg/dl for men and 70-125 mg/dl for women (fasting) 8.Hb > 13 for men and Hb > 11 for women with no other evidence of medical disorder resulting in blood loss or anemia/hematological disease
Who cannot join
- Physical dependence on any drugs, excluding nicotine and caffeine
- Participants requesting treatment
- Participants on parole or probation
- Pregnancy or lactation: Female participants must agree to the use of a barrier control method of contraception (e.g. male and female condoms, diaphragms, cervical caps and contraceptive sponges used in combination with spermicide)
- Current or recent history of significant violent behavior (within the past 6 months)
- Current major Axis I psychopathology that might interfere with ability to participate in the study
Show all 11Show fewer
- Significant suicide risk
- Current chronic pain
- Current or history of congestive heart failure, edema, or diabetes mellitus
- Sensitivity, allergy, or contraindication to opioids or pioglitazone
- Unstable physical disorders that might make participation hazardous, such as end-stage AIDS, hypertension (blood pressure > 140/90), or heart disease (please note that participants will be asked about previous visits to a cardiologist, chest pain, or strong palpitations; if these exist, they will be referred to a cardiologist and excluded unless cleared for participation by a cardiologist)
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia Univ/ NYSPI Division on Substance Abuse
New York, New York, 10032
About this study
The ability of pioglitazone (PIO) to alter the effects of opioids in humans has not been characterized in a controlled laboratory setting. Accordingly, the proposed investigation seeks to examine the effects of PIO on oxycodone, one of the most commonly used and abused opioid drugs in the U.S. (Davis et al., 2003). More specifically, the primary aim of this investigation is to characterize the subjective effects of oxycodone under maintenance on various doses of PIO (0, 15, and 45 mg) in non-dependent, prescription opioid abusers. Secondary aims of the study are to examine the influence of PIO on the analgesic, cognitive, and physiological effects of oxycodone.
Read the detailed description
This 9-week investigation will use an inpatient/outpatient design in which participants will be maintained on ascending doses of pioglitazone (3 weeks on placebo followed by 3 weeks on PIO 15 mg followed by 3 weeks on PIO 45 mg). At the end of each maintenance period the effects of oxycodone (0, 10, and 20 mg) will be examined during a single laboratory session using a cumulative dosing procedure.
- Conditions
- Opioid Abuse
- Being tested
- pioglitazone
- Keywords
- Oxycodone, Opioid abuse
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pioglitazoneDrug
Also called Actos
A PPARγ agonist, also marketed as Actos. Participants will be maintained on ascending doses of Placebo, pioglitazone 15 mg and 45 mg, prior to completing a lab session at the end of each dosing period.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Maintenance Period | Placebo comparator | Participants will complete the various outcome measures following a 2-3 week maintenance period on Placebo (PCB). Receives: Drug: pioglitazone |
| PIO 15 Maintenance Period | Experimental | Participants will complete the various outcome measures following a 2-3 week maintenance period on Pioglitazone (PIO) 15 mg. Receives: Drug: pioglitazone |
| PIO 45 Maintenance Period | Experimental | Participants will complete the various outcome measures following a 2-3 week maintenance period on Pioglitazone (PIO) 45 mg. Receives: Drug: pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Ratings of "Good" Drug Effect
Visual analog scale ratings (0-100 mm scale, 0=Not at all, 100=Extremely)
Measured: Measured during the lab session conducted at the end of each maintenance period
Secondary outcomes (1)
Analgesic Responses Using the Cold Pressor Test
Latency to withdraw hand from cold water during the cold pressor test.
Measured: Measured during the lab session conducted at the end of each maintenance period
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 startAug 2010
- Primary completionJan 2014
- Study completionApr 2014
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.
- Other trials for Opioid AbuseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Omeros Corporation
- Responsible party
- Sponsor
- Investigators
- Sandra D Comer, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395784
- Sponsor's protocol ID
- 6106
- Other IDs
- R01DA09236
- Status last verified
- Nov 2013
- First submitted
- 13 Jul 2011
- Last updated
- 23 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data has been presented at conferences and being prepared for a peer-review publication.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pioglitazone, a PPARgamma Receptor Agonist, on the Abuse Liability of Oxycodone
- ClinicalTrials.gov ID
- NCT01395784
- Acronym / sponsor ID
- 6106
- Conditions
- Opioid Abuse
- Keywords
- Oxycodone, Opioid abuse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Omeros Corporation
- Study start
- Aug 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 18 Jul 2011 (estimated)
- Results
- Posted 23 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ability of pioglitazone (PIO) to alter the effects of opioids in humans has not been characterized in a controlled laboratory setting. Accordingly, the proposed investigation seeks to examine the effects of PIO on oxycodone, one of the most commonly used and abused opioid drugs in the U.S. (Davis et al., 2003). More specifically, the primary aim of this investigation is to characterize the subjective effects of oxycodone under maintenance on various doses of PIO (0, 15, and 45 mg) in non-dependent, prescription opioid abusers. Secondary aims of the study are to examine the influence of PIO on the analgesic, cognitive, and physiological effects of oxycodone.
Detailed description
This 9-week investigation will use an inpatient/outpatient design in which participants will be maintained on ascending doses of pioglitazone (3 weeks on placebo followed by 3 weeks on PIO 15 mg followed by 3 weeks on PIO 45 mg). At the end of each maintenance period the effects of oxycodone (0, 10, and 20 mg) will be examined during a single laboratory session using a cumulative dosing procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo Maintenance Period | Placebo comparator | Drug: pioglitazoneParticipants will complete the various outcome measures following a 2-3 week maintenance period on Placebo (PCB). |
| PIO 15 Maintenance Period | Experimental | Drug: pioglitazoneParticipants will complete the various outcome measures following a 2-3 week maintenance period on Pioglitazone (PIO) 15 mg. |
| PIO 45 Maintenance Period | Experimental | Drug: pioglitazoneParticipants will complete the various outcome measures following a 2-3 week maintenance period on Pioglitazone (PIO) 45 mg. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Recreational use of prescription opioids at least once per month within the past year
- No current major mood, psychotic, or anxiety disorder
- Physically healthy
- aspartate aminotransferase (AST) or alanine aminotransferase (ALT) within normal limits
- Able to perform study procedures 6.21-45 years of age
Key exclusion criteria (11 listed)
- Physical dependence on any drugs, excluding nicotine and caffeine
- Participants requesting treatment
- Participants on parole or probation
- Pregnancy or lactation: Female participants must agree to the use of a barrier control method of contraception (e.g. male and female condoms, diaphragms, cervical caps and contraceptive sponges used in combination with spermicide)
- Current or recent history of significant violent behavior (within the past 6 months)
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 |
|---|---|---|
| pioglitazoneAlso: ActosA PPARγ agonist, also marketed as Actos. Participants will be maintained on ascending doses of Placebo, pioglitazone 15 mg and 45 mg, prior to completing a lab session at the end of each dosing period. | Drug | PIO 15 Maintenance Period, PIO 45 Maintenance Period, Placebo Maintenance Period |
Primary outcome
Subjective Ratings of "Good" Drug Effect
Time frame: Measured during the lab session conducted at the end of each maintenance period
Visual analog scale ratings (0-100 mm scale, 0=Not at all, 100=Extremely)
1 secondary outcome
Analgesic Responses Using the Cold Pressor Test
Time frame: Measured during the lab session conducted at the end of each maintenance period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data has been presented at conferences and being prepared for a peer-review publication.
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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 2 study testing pioglitazone in people with Opioid Abuse, 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 23 Feb 2016. 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 phase mean?
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 23 Feb 2016). 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?
Subjective Ratings of "Good" Drug Effect (time frame: Measured during the lab session conducted at the end of each maintenance period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2016.