Abuse PotentialPhase 4NCT06247488

Abuse Potential of HORIZANT With and Without Oxycodone in Healthy, Nondependent Recreational Opioid Users

A Phase 4 study testing Oxycodone 20 mg, GE-IR 200 mg and GE-IR 450 mg in people with Abuse Potential, run by Arbor Pharmaceuticals, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to assess the abuse potential of gabapentin enacarbil immediate release capsules taken alone and in combination with oxycodone in healthy adult, non-dependent, recreational opioid users. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Abuse Potential
What is being tested?: Oxycodone 20 mg, GE-IR 200 mg and GE-IR 450 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 110 participants
Where: 1 siteUnited States
Study dates: 31 Jan 2022to 25 Apr 2023
Phase: Phase 4
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 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Provision of signed and dated informed consent form (ICF),
Stated willingness to comply with all study procedures and availability for the duration of the study,
Male or female, between 18 and 55 years of age, inclusive,
Current nondependent, recreational opioid user who has used opioid drugs for recreational (nontherapeutic) purposes (i.e., for psychoactive effects) at least 5 times in the subject's lifetime and at least once in the last 12 weeks,
Body mass index (BMI) within 18.0 kg/m2 to 36.0 kg/m2, inclusive,
If female, meets 1 of the following criteria:

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If of childbearing potential agrees to use 1 of the accepted contraceptive regimens from at least 30 days prior to the first study treatment administration, during the study, and for at least 30 days after the last dose of the study treatment. An acceptable method of contraception includes 1 of the following:
Abstinence from heterosexual intercourse,
Hormonal contraceptives (birth control pills, injectable/implantable/insertable hormonal birth control products, transdermal patch), or
Intrauterine device (IUD; with or without hormones). Or
If of childbearing potential agrees to use a double barrier method (e.g., condom and spermicide) during the study and for at least 30 days after the last dose of study treatment.
Or
If of non-childbearing potential, defined as surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy or tubal ligation) or is in a postmenopausal state (i.e., at least 1 year without menses without an alternative medical condition and confirmed follicle stimulating hormone (FSH) ≥ 40 milli-International unit (mIU)/mL prior to the first study treatment administration),
If male and engaging in sexual activity that has the risk of pregnancy must agree to use a double barrier method (e.g., condom and spermicide) and agree to not donate sperm during the study and for at least 90 days after the last dose of study treatment, a male who has a pregnant partner shall be excluded,
Healthy, as determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs or clinical laboratory (including hematology, clinical chemistry, urinalysis, and serology [screening visit only]) at screening visit and admission, in the opinion of an investigator.
Negative COVID-19 test prior to each admission.

Who cannot join

History of significant hepatic, renal, cardiovascular, pulmonary, hematologic, neurological, psychiatric, gastrointestinal, endocrine, immunologic, ophthalmologic, or dermatologic disease of any etiology (including infections),
Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability with the exception that cholecystectomy is permitted at the discretion of an investigator,
Presence of any significant respiratory illness or presence or history of chronic respiratory disease (e.g., upper respiratory illness, sleep apnea, emphysema, asthma) at screening (subjects with acute respiratory illness may be rescheduled upon resolution at the discretion of an investigator),
Personal or family history (first degree relatives) of allergy, hypersensitivity, or drug rash with eosinophilia and systemic symptoms (DRESS) syndrome to gabapentin enacarbil,gabapentin or any drug product including naloxone, opioids (e.g., oxycodone), or related drugs or known excipients of any of the drug products in this study (e.g. lactose),
History of sensitivity to or poor tolerance of gabapentin enacarbil, gabapentin, pregabalin, naloxone, or oxycodone,
Female who is lactating at screening,

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Female who is pregnant according to the pregnancy test at screening or prior to the first study treatment administration or planning to become pregnant within 30 days following the last study treatment administration,
History of substance or alcohol dependence (excluding nicotine and caffeine) within the past 2 years, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), and/or subject has ever been in a drug or alcohol rehabilitation program within the last 2 years,
Subjects with positive urine drug screen (UDS) results at screening and admission will be assessed for inclusion at the discretion of an Investigator. If tetrahydrocannabinol (THC) is positive at admission to the qualification phase and treatment phase, a cannabis intoxication evaluation will be done by an investigator and subjects may be permitted to continue in the study, rescheduled, or discontinued at the discretion of an investigator. Other positive test results should be reviewed to determine if the subject may be rescheduled, in the opinion of the investigator,
Is a heavy smoker (>20 cigarettes per day or nicotine-equivalent) and/or is unable to abstain from smoking or unable to abstain from the use of prohibited nicotine-containing products for at least 1 hour before and 6 hours after study treatment administration (including e-cigarettes, pipes, cigars, chewing tobacco, nicotine topical patches, nicotine gum, or nicotine lozenges),
Is a heavy opioid user and not likely to be sensitive to a 20 mg dose of oxycodone, in the opinion of an investigator or designee,
Regularly consumes excessive amounts of caffeine or xanthines within 30 days prior to screening, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day,
History of suicidal ideation or suicidal behaviour within 2 years of screening, showing suicidal tendency as per the Columbia Suicide Severity Rating Scale (C-SSRS) administered at screening, or is currently at risk of suicide in the opinion of an investigator,
Presence of clinically significant ECG abnormalities at the screening visit, as defined by medical judgment, Note: QT corrected according to Fridericia's formula (QTcF) interval of >450 msec in male subjects or >470 msec in female subjects will be exclusionary. The ECG may be repeated once for confirmatory purposes if the initial value obtained exceeds the limits specified,
Has creatinine clearance ≤60ml/min as calculated by the Cockcroft-Gault equation,
Any history of tuberculosis,
Positive screening results to human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B virus surface antigen (HBsAg) or hepatitis C virus antibody (HCVAb) tests,
Intake of an investigational product (IP) within 30 days or 5 times the half-life (whichever is longer) prior to screening,
Use of any prescription drugs (with the exception of hormonal contraceptives or hormone replacement therapy) in the 30 days prior to the first study treatment administration, that in the opinion of an investigator would put into question the status of the subject as healthy,
Use of over-the-counter (OTC) products (including herbal preparations and supplements) within 7 days prior to the first study treatment administration, with the exception of ibuprofen or acetaminophen,
Use of a prohibited medication as specified in section 4.7,
Donation of plasma in the 7 days prior to screening,
Blood donation (excluding plasma) of approximately 500 mL of blood in the 56 days prior to screening,
Is, in the opinion of an investigator or designee, considered unsuitable or unlikely to comply with the study protocol for any reason.
Poor venous access at screening, as judged by an investigator.

Trial locations and contacts

1 site in 1 country.

United States1 site

Altasciences Clinical Kansas
Overland Park, Kansas, 66212

Other trials in United States

About this study

Official title: Randomized, Double-blind, Active & Placebo-controlled, 6-way Crossover Study of Abuse Potential of Oral Gabapentin Enacarbil IR Capsules With and Without Oxycodone in Healthy, Nondependent, Recreational Opioid Users

Read the detailed description

The primary purpose of this study is to evaluate the abuse potential of gabapentin enacarbil immediate-release (GE-IR), the active moiety in Horizant, taken alone and taken in combination with oxycodone, compared to that of oxycodone alone.

This study is a randomized, double-blind, active- and placebo-controlled, 6-way crossover design, aimed to assess the abuse potential, safety, and pharmacokinetics (PK) of GE-IR doses when administered alone or in combination with an opioid active control (oxycodone), and compared to placebo and oxycodone intake alone, in healthy, nondependent, recreational opioid users.

Conditions: Abuse Potential
Being tested: Placebo, Oxycodone 20 mg, GE-IR 200 mg, GE-IR 450 mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Also called matching over-encapsulated capsule
Participant will receive oral dose of placebo.
Oxycodone 20 mgDrug
Also called Oxycontin
Participant will receive oral dose of oxycodone 20 mg.
GE-IR 200 mgDrug
Also called Gabapentin Enacarbil, Horizant
Participant will receive oral dose of GE-IR 200 mg and oxycodone 20 mg.
GE-IR 450 mgDrug
Also called Gabapentin Enacarbil, Horizant
Participant will receive oral dose of GE-IR 450 mg and oxycodone 20 mg.

Study groups in NCT06247488
Study group	Role	What they receive
Placebo	Placebo comparator	oral masked Placebo Receives: Drug: Placebo
Oxycodone 20 mg	Active comparator	oral active control Receives: Drug: Oxycodone 20 mg
GE-IR 200mg	Experimental	single oral dose Receives: Drug: GE-IR 200 mg
GE-IR 450 mg	Experimental	single oral dose Receives: Drug: GE-IR 450 mg
GE-IR 200 mg + Oxycodone 20 mg	Experimental	oral doses given together Receives: Drug: Oxycodone 20 mg; Drug: GE-IR 200 mg
GE-IR 450 mg + Oxycodone 20 mg	Experimental	oral doses given together Receives: Drug: Oxycodone 20 mg; Drug: GE-IR 450 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Drug Liking Visual Analog Scale (VAS)
Mean difference in Drug Liking Emax over 24 hours for Drug Liking ("At this moment, my liking for this drug is"), assessed on a bipolar (0 to 100 points; 0: Strong disliking, 50: Neither like nor dislike, 100: Strong liking) VAS.
Measured: approximately 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, and 24 hours postdose in the treatment phase and per period of the treatment phase

Secondary outcomes (3)

Overall Drug Liking VAS
Mean difference in Emax for Overall Drug Liking ("Overall, my liking for this drug is"), assessed on a bipolar (0 to 100 points; 0: Strong disliking, 50: Neither like nor dislike, 100: Strong liking) VAS.
Measured: Approximately 12 and 24 hours postdose in the treatment phase and per period of the treatment phase
Take Drug Again VAS
Mean difference in Emax for Take Drug Again ("I would take this drug again"), assessed on a bipolar (0 to 100 points; 0: Definitely would not 50: Neither would nor would not, 100: Definitely would) VAS.
Measured: Approximately 12 and 24 hours postdose in the treatment phase and per period of the treatment phase
High VAS
Mean difference in Emax for High ("At this moment, I'm feeling high"), assessed on a unipolar (0 to 100 points; 0: Not at all, 100: Extremely) VAS.
Measured: within 1 hour prior to and approximately 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, and 24 hours postdose in the treatment phase and per period of the treatment phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jan 202225 Apr 2023

First posted8 Feb 2024
Study start31 Jan 2022
Primary completion25 Apr 2023
Study completion25 Apr 2023

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 Abuse PotentialStudies 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 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06247488
Sponsor's protocol ID: AR26.3031.2
Status last verified: Aug 2024
First submitted: 31 Jan 2024
Last updated: 12 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Abuse Potential trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-blind, Active & Placebo-controlled, 6-way Crossover Study of Abuse Potential of Oral Gabapentin Enacarbil IR Capsules With and Without Oxycodone in Healthy, Nondependent, Recreational Opioid Users
ClinicalTrials.gov ID: NCT06247488
Acronym / sponsor ID: AR26.3031.2
Conditions: Abuse Potential
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Arbor Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 31 Jan 2022 (actual)
Primary completion: 25 Apr 2023 (actual)
Study completion: 25 Apr 2023 (actual)
First posted: 8 Feb 2024 (actual)
Results: Posted 30 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebooral masked Placebo
Oxycodone 20 mg	Active comparator	Drug: Oxycodone 20 mgoral active control
GE-IR 200mg	Experimental	Drug: GE-IR 200 mgsingle oral dose
GE-IR 450 mg	Experimental	Drug: GE-IR 450 mgsingle oral dose
GE-IR 200 mg + Oxycodone 20 mg	Experimental	Drug: Oxycodone 20 mg, Drug: GE-IR 200 mgoral doses given together
GE-IR 450 mg + Oxycodone 20 mg	Experimental	Drug: Oxycodone 20 mg, Drug: GE-IR 450 mgoral doses given together

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (16 listed)

Provision of signed and dated informed consent form (ICF),
Stated willingness to comply with all study procedures and availability for the duration of the study,
Male or female, between 18 and 55 years of age, inclusive,
Current nondependent, recreational opioid user who has used opioid drugs for recreational (nontherapeutic) purposes (i.e., for psychoactive effects) at least 5 times in the subject's lifetime and at least once in the last 12 weeks,
Body mass index (BMI) within 18.0 kg/m2 to 36.0 kg/m2, inclusive,

Key exclusion criteria (25 listed)

History of significant hepatic, renal, cardiovascular, pulmonary, hematologic, neurological, psychiatric, gastrointestinal, endocrine, immunologic, ophthalmologic, or dermatologic disease of any etiology (including infections),
Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability with the exception that cholecystectomy is permitted at the discretion of an investigator,
Presence of any significant respiratory illness or presence or history of chronic respiratory disease (e.g., upper respiratory illness, sleep apnea, emphysema, asthma) at screening (subjects with acute respiratory illness may be rescheduled upon resolution at the discretion of an investigator),
Personal or family history (first degree relatives) of allergy, hypersensitivity, or drug rash with eosinophilia and systemic symptoms (DRESS) syndrome to gabapentin enacarbil,gabapentin or any drug product including naloxone, opioids (e.g., oxycodone), or related drugs or known excipients of any of the drug products in this study (e.g. lactose),
History of sensitivity to or poor tolerance of gabapentin enacarbil, gabapentin, pregabalin, naloxone, or oxycodone,

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
PlaceboAlso: matching over-encapsulated capsuleParticipant will receive oral dose of placebo.	Drug	Placebo
Oxycodone 20 mgAlso: OxycontinParticipant will receive oral dose of oxycodone 20 mg.	Drug	GE-IR 200 mg + Oxycodone 20 mg, GE-IR 450 mg + Oxycodone 20 mg, Oxycodone 20 mg
GE-IR 200 mgAlso: Gabapentin Enacarbil, HorizantParticipant will receive oral dose of GE-IR 200 mg and oxycodone 20 mg.	Drug	GE-IR 200 mg + Oxycodone 20 mg, GE-IR 200mg
GE-IR 450 mgAlso: Gabapentin Enacarbil, HorizantParticipant will receive oral dose of GE-IR 450 mg and oxycodone 20 mg.	Drug	GE-IR 450 mg, GE-IR 450 mg + Oxycodone 20 mg

Primary outcome

Drug Liking Visual Analog Scale (VAS)
Time frame: approximately 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, and 24 hours postdose in the treatment phase and per period of the treatment phase
Mean difference in Drug Liking Emax over 24 hours for Drug Liking ("At this moment, my liking for this drug is"), assessed on a bipolar (0 to 100 points; 0: Strong disliking, 50: Neither like nor dislike, 100: Strong liking) VAS.

3 secondary outcomes

Overall Drug Liking VAS
Time frame: Approximately 12 and 24 hours postdose in the treatment phase and per period of the treatment phase
Take Drug Again VAS
Time frame: Approximately 12 and 24 hours postdose in the treatment phase and per period of the treatment phase
High VAS
Time frame: within 1 hour prior to and approximately 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, and 24 hours postdose in the treatment phase and per period of the treatment phase

Results and safety

Results posted to the registry on 30 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ABFCED	10	10
BCADFE	10	10
CBDEAF	11	11
DECFBA	12	12
EFDACB	10	10
FAEBDC	10	10

Primary outcome: Drug Liking Visual Analog Scale (VAS)

Time frame: approximately 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, and 24 hours postdose in the treatment phase and per period of the treatment phase. Mean (Standard Error). Unit: score on a scale

Measure	Placebo n = 54	Oxycodone 20 mg n = 54	GE-IR 200mg n = 54	GE-IR 450 mg n = 54	GE-IR 200 mg + Oxycodone 20 mg n = 54	GE-IR 450 mg + Oxycodone 20 mg n = 54
Value	56.4 (1.75)	84.9 (2.08)	59.6 (2.28)	64.6 (2.45)	84.5 (2.11)	86.6 (2.03)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were monitored through the 3-day qualification phase, and throughout the 17-day treatment phase until the final follow-up visit at day 23 (+/- 2 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 61 (0%)	12 of 61 (19.7%)	0 of 61
Oxycodone 20 mg	0 of 61 (0%)	24 of 61 (39.3%)	0 of 61
GE-IR 200mg	0 of 60 (0%)	8 of 60 (13.3%)	0 of 60
GE-IR 450 mg	0 of 60 (0%)	16 of 60 (26.7%)	0 of 60
GE-IR 200 mg + Oxycodone 20 mg	0 of 57 (0%)	28 of 57 (49.1%)	0 of 57
GE-IR 450 mg + Oxycodone 20 mg	0 of 61 (0%)	33 of 61 (54.1%)	0 of 61

Limitations and caveats (from the sponsor): 63 subjects entered the treatment phase and were assessed for adverse events. 11 discontinued over the course of the 6 study periods. 54 subjects were part of the analysis population. This met the study goal for population.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oxycodone 20 mg, GE-IR 200 mg and GE-IR 450 mg in people with Abuse Potential, run by Arbor Pharmaceuticals, Inc. 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 16 inclusion and 25 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 12 Aug 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 30 Jul 2024). 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 Liking Visual Analog Scale (VAS) (time frame: approximately 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, and 24 hours postdose in the treatment phase and per period of the treatment phase). 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 NCT06247488.

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 12 Aug 2024.