Opioid-Related DisordersPhase 2NCT00734461
Study to Evaluate the Subjective Effects of PTI-801 in Non-Physically Dependent Subjects With a History of Drug Abuse
A Phase 2 study testing oxycodone and naltrexone in people with Opioid-Related Disorders, run by Pain Therapeutics at 1 site in United States.
Trial summary
This is a single-center, randomized, 7-way crossover, double-blind, active and placebo-controlled study to evaluate the subjective effects of oxycodone combined with ultra-low dose naltrexone in comparison to oxycodone alone in non-physically dependent subjects with a history of opioid abuse. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid-Related Disorders
- What is being tested?
- oxycodone and naltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Mar 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females who are at least 18 and no more than 65 years of age.
- The subject is in good health as determined by medical history and physical examination.
- The subject is willing and able to speak, read, and understand English and provide written informed consent.
- The subject's urine drug screen and ethanol breath test are negative at check-in to the clinic.
- The subject has a history of polydrug abuse and: Has taken illicit opioids within the last 30 days; and/or Misused/abused prescription opioids within the last 30 days.
- The subject is willing and able to comply with all testing and requirements defined in the protocol.
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- The subject must agree to refrain from caffeine and xanthine-containing products throughout the study, and to refrain from nicotine from 1 hour prior to each dosing until 4 hours after each dosing.
- The subject is willing and able to remain at the study site unit for the duration of the study.
- The subject has a positive response to oxycodone in the blinded qualifying period as defined by a VAS Liking score for oxycodone that is at least 20 points greater than that for placebo.
- Females who are postmenopausal, physically incapable of childbearing, or practicing an acceptable method of birth control. Acceptable methods of birth control include surgical sterilization, hormonal contraceptives, or double-barrier methods (condom or diaphragm with a spermicidal agent or intrauterine device [IUD]). A negative pregnancy test result must be obtained for all females at screening and at check-in to the clinic.
Who cannot join
- The subject has a positive urine drug screen or ethanol breath test at check-in to the clinic.
- The subject has been taking prescription opioids daily for chronic pain or has been taking illicit or prescription opioids daily for recreational purposes for more than 20 days in the last month.
- The subject is enrolled in treatment for drug abuse or is actively seeking treatment for drug abuse.
- The subject has any significant deviations from normal in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator.
- The subject has had a clinically significant illness within 30 days preceding entry into this study.
- The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.
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- The subject has a history of an allergic reaction to oxycodone or structurally similar compounds (morphine, hydromorphone, hydrocodone, levorphanol, pentazocine, codeine, etc.), naltrexone or other narcotic agonists.
- The subject has used any prescription medication (besides hormonal contraceptives) or recreational drugs within 7 days or over-the-counter (OTC) medication within 48 hours of check-in to the clinic or intends to use any prescription, recreational drugs or OTC medication during the study that may interfere with the evaluation of study medication.
- The subject has used alcohol, grapefruit, or grapefruit juice 24 hours before check-in to the clinic or intends to use any of these products during the study.
- The subject is pregnant or breastfeeding.
- The subject has received an investigational drug within 30 days prior to initiation of this study.
- The subject exhibits signs/symptoms of opioid withdrawal during the 24-hour observation period after check-in.
- The subject has a history of hospitalization due to a psychiatric disorder within the previous year or a current major psychiatric disorder. (Substance abuse disorders are not exclusionary).
- The subject experiences any of the following within 4 hours after administration of oxycodone 30 mg during the blinded qualifying dosing period: adverse events requiring narcotic antagonist administration, emesis, or opioid toxicity (see Section 10.0).
- The subject is unwilling to reside in the study unit for the inpatient portion of the study or to cooperate fully with the investigator or site personnel.
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224-6823
About this study
Official title: A Single-Center, Randomized, Double-Blind, Active- and Placebo-Controlled Crossover Study to Evaluate the Subjective Effects of PTI-801 in Non-Physically Dependent Subjects With a History of Drug Abuse
This is a single-center, randomized, 7-way crossover, double-blind, active and placebo-controlled study to evaluate the subjective effects of oxycodone combined with ultra-low dose naltrexone in comparison to oxycodone alone in non-physically dependent subjects with a history of opioid abuse. Approximately 14 subjects will be randomized to one of fourteen sequences selected from a balanced 7x7 Latin square design and its mirror image.
Read the detailed description
At the conclusion of a screening period, qualifying subjects with a negative urine drug screen and ethanol breath test will be admitted to an inpatient research unit. After a 24 hour observation period confirming that the subject is not undergoing opioid withdrawal, subjects will randomly receive either 30 mg oxycodone or matching placebo over two consecutive days in a double-blind fashion. The purpose of this oxycodone vs. placebo qualifying period is to select for subjects with a positive drug liking response and to orient subjects to the various scales. Only subjects with a positive response on the visual analog "Liking" scale of at least 20 points higher on active oxycodone vs. placebo will be eligible to continue in the double-blind 7-way crossover study. Fourteen subjects will be randomized to one of fourteen sequences.
Each subject will receive a single dose of one of the following 7 treatments:
Placebo, oxycodone 20 mg, oxycodone 40 mg, oxycodone 20 mg/naltrexone 0.001 mg, oxycodone 40 mg/naltrexone 0.001 mg,oxycodone 20 mg/naltrexone 0.0001 mg, oxycodone 40 mg/naltrexone 0.0001 mg.
Oxycodone and naltrexone will be formulated in combination as a single tablet. All tablets will be identical in appearance. The identity of each treatment will be unknown to all study personnel and subjects.
Immediately prior to and at specified time points after administration of a single dose of study drug, subjects will complete the following subjective scales: visual analog scales (VAS) for any drug effect, high, good effects, bad effects, liking, and sick; and adjective ratings (agonist and antagonist scales). Subjects will also be asked to complete a money versus drug questionnaire at various time points after drug administration. Observers will complete an adjective rating scale. Safety will be monitored by vital signs (heart rate, blood pressure, respiratory rate, and pulse oximetry), adverse events assessments, clinical laboratory tests, physical examinations and electrocardiograms (ECGs). In addition, pupil diameter (measured by photographs) will be obtained to monitor for physiological signs of opioid effects.
The first double-blind dose of study drug will be administered at least 24 hours after the last dose of the two day qualifying period. Dosings will be separated by a washout period of at least 120 hours (see sample calendar in Section 6.5). The observation period for safety will continue for 24 hours following the final dose of study drug.
- Conditions
- Opioid-Related Disorders
- Being tested
- oxycodone and naltrexone
- Keywords
- Non-physically dependent subjects, history of 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.
oxycodone and naltrexoneDrug
tablets containing 20 mg or 40 mg oxycodone
/ tablets containing 20 mg or 40 mg oxycodone combined w/0.001 mg or 0.0001 mg naltrexone
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo, single dose Receives: Drug: oxycodone and naltrexone |
| Oxycodone 20 mg | Active comparator | Oxycodone 20 mg single dose tablet Receives: Drug: oxycodone and naltrexone |
| Oxycodone 40 mg | Active comparator | Oxycodone 40 mg single dose tablet Receives: Drug: oxycodone and naltrexone |
| PTI-801 20/.001 mg | Experimental | Oxycodone 20 mg / Naltrexone 0.001 mg Receives: Drug: oxycodone and naltrexone |
| PTI-801 40/.001 mg | Experimental | Oxycodone 40 mg / Naltrexone 0.001 mg Receives: Drug: oxycodone and naltrexone |
| PTI-801 20/.0001 mg | Experimental | Oxycodone 40 mg / Naltrexone 0.0001 mg Receives: Drug: oxycodone and naltrexone |
| PTI-801 40/.0001 mg | Experimental | Oxycodone 40 mg / Naltrexone 0.0001 mg Receives: Drug: oxycodone and naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to evaluate the subjective effects of PTI-801 formulated with either 0.001 mg naltrexone or 0.0001 mg naltrexone compared to oxycodone alone in individuals with a history of opioid abuse.
Measured: At 30, 60, 90, 120, 150, 180 and 210 minutes post-dose
Secondary outcomes (1)
Secondary objectives include determining the safety and physiological effects of single doses of PTI-801 compared to oxycodone following oral administration in individuals with a history of opioid abuse.
Measured: At 30, 60, 90, 120, 150, 180 and 210 minutes post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startAug 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Related DisordersStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pain Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George E Bigelow, PhD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734461
- Sponsor's protocol ID
- PTI-801-XM
- Status last verified
- Mar 2016
- First submitted
- 12 Aug 2008
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Double-Blind, Active- and Placebo-Controlled Crossover Study to Evaluate the Subjective Effects of PTI-801 in Non-Physically Dependent Subjects With a History of Drug Abuse
- ClinicalTrials.gov ID
- NCT00734461
- Acronym / sponsor ID
- PTI-801-XM
- Conditions
- Opioid-Related Disorders
- Keywords
- Non-physically dependent subjects, history of opioid abuse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Pain TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 14 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, randomized, 7-way crossover, double-blind, active and placebo-controlled study to evaluate the subjective effects of oxycodone combined with ultra-low dose naltrexone in comparison to oxycodone alone in non-physically dependent subjects with a history of opioid abuse. Approximately 14 subjects will be randomized to one of fourteen sequences selected from a balanced 7x7 Latin square design and its mirror image.
Detailed description
At the conclusion of a screening period, qualifying subjects with a negative urine drug screen and ethanol breath test will be admitted to an inpatient research unit. After a 24 hour observation period confirming that the subject is not undergoing opioid withdrawal, subjects will randomly receive either 30 mg oxycodone or matching placebo over two consecutive days in a double-blind fashion. The purpose of this oxycodone vs. placebo qualifying period is to select for subjects with a positive drug liking response and to orient subjects to the various scales. Only subjects with a positive response on the visual analog "Liking" scale of at least 20 points higher on active oxycodone vs. placebo will be eligible to continue in the double-blind 7-way crossover study. Fourteen subjects will be randomized to one of fourteen sequences.
Each subject will receive a single dose of one of the following 7 treatments:
Placebo, oxycodone 20 mg, oxycodone 40 mg, oxycodone 20 mg/naltrexone 0.001 mg, oxycodone 40 mg/naltrexone 0.001 mg,oxycodone 20 mg/naltrexone 0.0001 mg, oxycodone 40 mg/naltrexone 0.0001 mg.
Oxycodone and naltrexone will be formulated in combination as a single tablet. All tablets will be identical in appearance. The identity of each treatment will be unknown to all study personnel and subjects.
Immediately prior to and at specified time points after administration of a single dose of study drug, subjects will complete the following subjective scales: visual analog scales (VAS) for any drug effect, high, good effects, bad effects, liking, and sick; and adjective ratings (agonist and antagonist scales). Subjects will also be asked to complete a money versus drug questionnaire at various time points after drug administration. Observers will complete an adjective rating scale. Safety will be monitored by vital signs (heart rate, blood pressure, respiratory rate, and pulse oximetry), adverse events assessments, clinical laboratory tests, physical examinations and electrocardiograms (ECGs). In addition, pupil diameter (measured by photographs) will be obtained to monitor for physiological signs of opioid effects.
The first double-blind dose of study drug will be administered at least 24 hours after the last dose of the two day qualifying period. Dosings will be separated by a washout period of at least 120 hours (see sample calendar in Section 6.5). The observation period for safety will continue for 24 hours following the final dose of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: oxycodone and naltrexonePlacebo, single dose |
| Oxycodone 20 mg | Active comparator | Drug: oxycodone and naltrexoneOxycodone 20 mg single dose tablet |
| Oxycodone 40 mg | Active comparator | Drug: oxycodone and naltrexoneOxycodone 40 mg single dose tablet |
| PTI-801 20/.001 mg | Experimental | Drug: oxycodone and naltrexoneOxycodone 20 mg / Naltrexone 0.001 mg |
| PTI-801 40/.001 mg | Experimental | Drug: oxycodone and naltrexoneOxycodone 40 mg / Naltrexone 0.001 mg |
| PTI-801 20/.0001 mg | Experimental | Drug: oxycodone and naltrexoneOxycodone 40 mg / Naltrexone 0.0001 mg |
| PTI-801 40/.0001 mg | Experimental | Drug: oxycodone and naltrexoneOxycodone 40 mg / Naltrexone 0.0001 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and females who are at least 18 and no more than 65 years of age.
- The subject is in good health as determined by medical history and physical examination.
- The subject is willing and able to speak, read, and understand English and provide written informed consent.
- The subject's urine drug screen and ethanol breath test are negative at check-in to the clinic.
- The subject has a history of polydrug abuse and: Has taken illicit opioids within the last 30 days; and/or Misused/abused prescription opioids within the last 30 days.
Key exclusion criteria (15 listed)
- The subject has a positive urine drug screen or ethanol breath test at check-in to the clinic.
- The subject has been taking prescription opioids daily for chronic pain or has been taking illicit or prescription opioids daily for recreational purposes for more than 20 days in the last month.
- The subject is enrolled in treatment for drug abuse or is actively seeking treatment for drug abuse.
- The subject has any significant deviations from normal in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator.
- The subject has had a clinically significant illness within 30 days preceding entry into this study.
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 |
|---|---|---|
| oxycodone and naltrexonetablets containing 20 mg or 40 mg oxycodone / tablets containing 20 mg or 40 mg oxycodone combined w/0.001 mg or 0.0001 mg naltrexone | Drug | Oxycodone 20 mg, Oxycodone 40 mg, PTI-801 20/.0001 mg, PTI-801 20/.001 mg, PTI-801 40/.0001 mg, PTI-801 40/.001 mg, Placebo |
Primary outcome
The primary objective of this study is to evaluate the subjective effects of PTI-801 formulated with either 0.001 mg naltrexone or 0.0001 mg naltrexone compared to oxycodone alone in individuals with a history of opioid abuse.
Time frame: At 30, 60, 90, 120, 150, 180 and 210 minutes post-dose
1 secondary outcome
Secondary objectives include determining the safety and physiological effects of single doses of PTI-801 compared to oxycodone following oral administration in individuals with a history of opioid abuse.
Time frame: At 30, 60, 90, 120, 150, 180 and 210 minutes post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
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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.
George E Bigelow, PhD principal investigator
Johns Hopkins School of Medicine
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 oxycodone and naltrexone in people with Opioid-Related Disorders, run by Pain Therapeutics 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 10 inclusion and 15 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 2 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary objective of this study is to evaluate the subjective effects of PTI-801 formulated with either 0.001 mg naltrexone or 0.0001 mg naltrexone compared to oxycodone alone in individuals with a history of opioid abuse. (time frame: At 30, 60, 90, 120, 150, 180 and 210 minutes post-dose). 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 2 May 2016.