Recreational Drug UsePhase 1NCT05567354
A Study to Evaluate the Intranasal Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-103)
A Phase 1 study testing PF614 and Oxycodone in people with Recreational Drug Use, run by Ensysce Biosciences at 1 site in United States.
Trial summary
The purpose of this study is to examine the abuse potential and pharmacokinetics of PF614 compared with a non-abuse deterrent, commercially available, immediate release (IR) oxycodone hydrochloride (HCl) formulation and placebo. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Recreational Drug Use
- What is being tested?
- PF614 and Oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2022to 31 Aug 2022
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females, aged 18 to 55 years, inclusive, in good general health.
- Body mass index (BMI) within the range of 18.0 to 33.0 kg/m2, inclusive, and a minimum weight of 50.0 kg.
- Current opioid users who have used opioids for recreational (non-therapeutic) purposes (i.e., for psychoactive effects) at least 10 times in the past year and at least once in the 12 weeks before Screening.
- Must have experience with intranasal opioids for the purpose of recreational (non-therapeutic) use on at least 3 occasions in the year prior to Screening.
- Must not be physically dependent on opioids, as demonstrated by successful completion of the Naloxone Challenge Test.
- Must meet Drug Discrimination Test eligibility criteria (Section 8.3).
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- Female subjects must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at randomization. Post-menopausal women (i.e., no menstrual period for at least one year) must have a follicle-stimulation hormone (FSH) level >30 milli-international unit (mIU)/mL at Screening.
- Female subjects must use a medically acceptable method of birth control (oral or transdermal contraceptives, condom, spermicidal foam, intrauterine device (IUD), progestin implant or injection, heterosexual abstinence, vaginal ring or sterilization of partner) from the time of Screening through 2 weeks after the last study treatment.
- Male subjects must agree to use medically acceptable methods of contraception (diaphragm/sponge/condom with spermicide, vasectomy), and/or their female sexual partners of childbearing potential must be using and willing to continue to use medically acceptable contraception (i.e., hormonal oral contraceptive pills, patches, or vaginal rings, contraceptive implant or injection intrauterine contraceptive system [with or without hormone]) from Screening and for at least 90 days after the last study drug administration.
- Able to speak, read and understand English sufficiently to allow completion of all study assessments.
- Subjects must be able to provide meaningful written informed consent.
- Subjects must be willing and able to follow study instructions and be likely to complete all study requirements.
Who cannot join
- Substance or alcohol dependence (excluding nicotine and caffeine) within the past 2 years, as defined by the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition - Text Revision (DSM IV-TR), and/or has ever participated or plans to participate in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence.
- History or presence of clinically significant abnormality as assessed by physical examination, medical history, electrocardiograms (ECGs), vital signs or laboratory values, which, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results. Retesting may be permitted at the discretion of the investigator.
- History or presence of acute respiratory depression, chronic pulmonary disease, cor pulmonale, delirium tremens, central nervous system (CNS) depression, or increased cerebrospinal or intracranial pressure.
- Documented history of or currently active seizure disorder (excluding febrile seizures in childhood) or history of clinically significant head injury or syncope of unknown origin.
- History of gastrointestinal disturbance requiring frequent use of antacids.
- Subjects with a history of suicidal ideation within the past 6 months or a lifetime history of suicidal behavior, as assessed by the C SSRS (baseline version).
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- Heavy smoker (>20 cigarettes per day) and/or is unable to abstain from smoking while housed at the clinical site.
- History of allergy or hypersensitivity to oxycodone, any other opioid or naloxone.
- Female subjects who are currently pregnant (have a positive pregnancy test) or lactating or who are planning to become pregnant within 30 days of last study drug administration.
- Positive for hepatitis B surface antigen (HBsAg), hepatitis C, human immunodeficiency virus (HIV) or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
- Evidence of clinically significant hepatic or renal impairment, including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 × the upper limit of normal (ULN). Retesting may be permitted at the discretion of the investigator.
- Donation or loss of more than 500 mL whole blood within 30 days preceding entry into the Treatment Phase.
- Difficulty with venous access or unsuitable or unwilling to undergo catheter insertion.
- Use of a prohibited medication or investigational product, as specified in Section 9.7.1.
- Is an employee of the sponsor or research site personnel directly affiliated with this study, or is an immediate family member of any of these persons, defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- Falls under any other condition, that, in the investigator's opinion, (i) puts the subject at increased risk, (ii) could confound the study results, (iii) may interfere significantly with the subject's participation in the study, or (iv) has the potential to limit the subject's ability to complete the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-and Active-Controlled Crossover Study to Evaluate the Intranasal Abuse Potential of PF614 Compared with Immediate-Release Oxycodone and Placebo in Non-Dependent Recreational Opioid Users
The purpose of this study is to examine the abuse potential and pharmacokinetics of PF614 compared with a non-abuse deterrent, commercially available, immediate release (IR) oxycodone hydrochloride (HCl) formulation and placebo.
Read the detailed description
This will be a randomized, double-blind, placebo-and active-controlled, 3-way crossover study to evaluate the abuse potential and pharmacokinetics of intranasally administered PF614, relative to crushed oxycodone HCl IR tablets and placebo in non-dependent recreational opioid users. The study will consist of 4 phases: Screening, Qualification, Treatment, and Follow-up.
- Conditions
- Recreational Drug Use
- Being tested
- PF614, Oxycodone, Placebo
- Medical subject headings
- Recreational Drug Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF614Drug
Also called Oxycodone prodrug
PF614 100 mg capsules
OxycodoneDrug
Also called Oxycodone hydrochloride (HCl) immediate-release (IR) tablets
Oxycodone HCl IR 40mg
PlaceboOther
placebo powder
| Study group | Role | What they receive |
|---|---|---|
| PF614 100 mg capsule | Experimental | Eligible subjects will be admitted to the clinical site on Day-1. Subjects will receive PF614 100mg capsules in a randomized, double-blind, crossover manner. Receives: Drug: PF614 |
| Oxycodone HCl tablets | Active comparator | Eligible subjects will be admitted to the clinical site on Day -1. Subjects will receive crushed oxycodone HCl IR 40mg in a randomized, double-blind, crossover manner. Receives: Drug: Oxycodone |
| Placebo powder in capsules | Placebo comparator | Eligible subjects will be admitted to the clinical site on Day-1. Subjects will receive Placebo powder in a randomized, double-blind, crossover manner. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Maximum Effect (Emax) for Drug Liking (At this Moment) Visual Analog Scale (VAS)
Relative abuse potential of PF614 compared to Oxycodone and Placebo (I). Emax for drug liking VAS will be reported. Drug liking VAS is a bipolar scale designed to assess a participant's liking for a given study intervention at the time the question is being asked (that is, at this moment). It is scored as an integer ranging from 0 (strong disliking) to 100 (strong liking)
Measured: Up to 24 hour post-dose (up to Day 2)
Take Drug again VAS (Emax)
Relative abuse potential of PF614 compared to Oxycodone and Placebo (II). Emax for take drug again VAS will be reported. Peak effect for take drug again based on bipolar VAS from 0 (definitely no) to 100 (definitely so).
Measured: 12 and 24 hours post-dose
Secondary outcomes (6)
Maximum Plasma Concentration (Cmax)
Compare the peak plasma concentration of oxycodone derived from PF614 and oxycodone derived from oxycodone IR tablets
Measured: Up to 24 hour post-dose (up to Day 2)
Time to Peak Plasma Concentration (Tmax)
Compare the time to peak plasma concentration of oxycodone derived from PF614 and oxycodone derived from oxycodone IR tablets
Measured: Up to 24 hour post-dose (up to Day 2)
Area Under the Curve Plasma Concentration (AUC 0-24)
Compare the 0-24 hr pharmacokinetic profile of oxycodone derived from PF614 and oxycodone derived from oxycodone IR tablets
Measured: Up to 24 hour post-dose (up to Day 2)
Adverse events (AEs)
Safety
Measured: Through study completion, an average of 7 weeks
Serious adverse events (SAEs)
Safety
Measured: Through study completion, an average of 7 weeks
AEs leading to discontinuation
Safety
Measured: Through study completion, an average of 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start10 Jun 2022
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Recreational Drug UseStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This will be a 3 way crossover study to evaluate the abuse potential of PF614.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ensysce Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glen Apseloff, MD, FCP, Principal investigator, Ohio Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567354
- Sponsor's protocol ID
- PF614-103
- Status last verified
- Dec 2022
- First submitted
- 22 May 2022
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kirkpatrick DL, Evans C, Pestano LA, Millard J, Johnston M, Mick E, Schmidt WK. Clinical evaluation of PF614, a novel TAAP prodrug of oxycodone, versus OxyContin in a multi-ascending dose study with a bioequivalence arm in healthy volunteers. Clin Transl Sci. 2024 Mar;17(3):e13765. doi: 10.1111/cts.13765.
PubMed 38511523Kirkpatrick DL, Schmidt WK, Morales R, Cremin J, Seroogy J, Husfeld C, Jenkins T. In vitro and in vivo assessment of the abuse potential of PF614, a novel BIO-MD prodrug of oxycodone. J Opioid Manag. 2017 Jan/Feb;13(1):39-49. doi: 10.5055/jom.2017.0366.
PubMed 28345745
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-and Active-Controlled Crossover Study to Evaluate the Intranasal Abuse Potential of PF614 Compared with Immediate-Release Oxycodone and Placebo in Non-Dependent Recreational Opioid Users
- ClinicalTrials.gov ID
- NCT05567354
- Acronym / sponsor ID
- PF614-103
- Conditions
- Recreational Drug Use
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Ensysce BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 5 Oct 2022 (actual)
- 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.
The purpose of this study is to examine the abuse potential and pharmacokinetics of PF614 compared with a non-abuse deterrent, commercially available, immediate release (IR) oxycodone hydrochloride (HCl) formulation and placebo.
Detailed description
This will be a randomized, double-blind, placebo-and active-controlled, 3-way crossover study to evaluate the abuse potential and pharmacokinetics of intranasally administered PF614, relative to crushed oxycodone HCl IR tablets and placebo in non-dependent recreational opioid users. The study will consist of 4 phases: Screening, Qualification, Treatment, and Follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This will be a 3 way crossover study to evaluate the abuse potential of PF614.
| Arm | Type | Receives |
|---|---|---|
| PF614 100 mg capsule | Experimental | Drug: PF614Eligible subjects will be admitted to the clinical site on Day-1. Subjects will receive PF614 100mg capsules in a randomized, double-blind, crossover manner. |
| Oxycodone HCl tablets | Active comparator | Drug: OxycodoneEligible subjects will be admitted to the clinical site on Day -1. Subjects will receive crushed oxycodone HCl IR 40mg in a randomized, double-blind, crossover manner. |
| Placebo powder in capsules | Placebo comparator | Other: PlaceboEligible subjects will be admitted to the clinical site on Day-1. Subjects will receive Placebo powder in a randomized, double-blind, crossover manner. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Males or females, aged 18 to 55 years, inclusive, in good general health.
- Body mass index (BMI) within the range of 18.0 to 33.0 kg/m2, inclusive, and a minimum weight of 50.0 kg.
- Current opioid users who have used opioids for recreational (non-therapeutic) purposes (i.e., for psychoactive effects) at least 10 times in the past year and at least once in the 12 weeks before Screening.
- Must have experience with intranasal opioids for the purpose of recreational (non-therapeutic) use on at least 3 occasions in the year prior to Screening.
- Must not be physically dependent on opioids, as demonstrated by successful completion of the Naloxone Challenge Test.
Key exclusion criteria (16 listed)
- Substance or alcohol dependence (excluding nicotine and caffeine) within the past 2 years, as defined by the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition - Text Revision (DSM IV-TR), and/or has ever participated or plans to participate in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence.
- History or presence of clinically significant abnormality as assessed by physical examination, medical history, electrocardiograms (ECGs), vital signs or laboratory values, which, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results. Retesting may be permitted at the discretion of the investigator.
- History or presence of acute respiratory depression, chronic pulmonary disease, cor pulmonale, delirium tremens, central nervous system (CNS) depression, or increased cerebrospinal or intracranial pressure.
- Documented history of or currently active seizure disorder (excluding febrile seizures in childhood) or history of clinically significant head injury or syncope of unknown origin.
- History of gastrointestinal disturbance requiring frequent use of antacids.
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 |
|---|---|---|
| PF614Also: Oxycodone prodrugPF614 100 mg capsules | Drug | PF614 100 mg capsule |
| OxycodoneAlso: Oxycodone hydrochloride (HCl) immediate-release (IR) tabletsOxycodone HCl IR 40mg | Drug | Oxycodone HCl tablets |
| Placeboplacebo powder | Other | Placebo powder in capsules |
Primary outcome
Peak Maximum Effect (Emax) for Drug Liking (At this Moment) Visual Analog Scale (VAS)
Time frame: Up to 24 hour post-dose (up to Day 2)
Relative abuse potential of PF614 compared to Oxycodone and Placebo (I). Emax for drug liking VAS will be reported. Drug liking VAS is a bipolar scale designed to assess a participant's liking for a given study intervention at the time the question is being asked (that is, at this moment). It is scored as an integer ranging from 0 (strong disliking) to 100 (strong liking)
Take Drug again VAS (Emax)
Time frame: 12 and 24 hours post-dose
Relative abuse potential of PF614 compared to Oxycodone and Placebo (II). Emax for take drug again VAS will be reported. Peak effect for take drug again based on bipolar VAS from 0 (definitely no) to 100 (definitely so).
6 secondary outcomes
Maximum Plasma Concentration (Cmax)
Time frame: Up to 24 hour post-dose (up to Day 2)
Time to Peak Plasma Concentration (Tmax)
Time frame: Up to 24 hour post-dose (up to Day 2)
Area Under the Curve Plasma Concentration (AUC 0-24)
Time frame: Up to 24 hour post-dose (up to Day 2)
Adverse events (AEs)
Time frame: Through study completion, an average of 7 weeks
Serious adverse events (SAEs)
Time frame: Through study completion, an average of 7 weeks
AEs leading to discontinuation
Time frame: Through study completion, an average of 7 weeks
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 24 Sep 2024.
- Background: PubMed 38511523Kirkpatrick DL, Evans C, Pestano LA, Millard J, Johnston M, Mick E, Schmidt WK. Clinical evaluation of PF614, a novel TAAP prodrug of oxycodone, versus OxyContin in a multi-ascending dose study with a bioequivalence arm in healthy volunteers. Clin Transl Sci. 2024 Mar;17(3):e13765. doi: 10.1111/cts.13765.
- Background: PubMed 28345745Kirkpatrick DL, Schmidt WK, Morales R, Cremin J, Seroogy J, Husfeld C, Jenkins T. In vitro and in vivo assessment of the abuse potential of PF614, a novel BIO-MD prodrug of oxycodone. J Opioid Manag. 2017 Jan/Feb;13(1):39-49. doi: 10.5055/jom.2017.0366.
- Individual participant dataSharing planned: No
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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.
Glen Apseloff, MD, FCP principal investigator
Ohio Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF614 and Oxycodone in people with Recreational Drug Use, run by Ensysce Biosciences 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 12 inclusion and 16 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 24 Sep 2024. 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 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.
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?
Peak Maximum Effect (Emax) for Drug Liking (At this Moment) Visual Analog Scale (VAS) (time frame: Up to 24 hour post-dose (up to Day 2)). The study lists 2 primary outcomes in all. 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 NCT05567354, which also lists 2 linked publications.
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 24 Sep 2024.