Abuse PotentialPhase 4NCT06097676
An Abuse Potential Study of Orally Administered HORIZANT in Healthy, Non-dependent, Recreational Drug Users
A Phase 4 study testing Alprazolam 2 mg, Gabapentin Enacarbil Immediate Release (GE-IR) 200 mg and Gabapentin Enacarbil Immediate Release (GE-IR) 450 mg in people with Abuse Potential, run by Arbor Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the abuse potential of gabapentin enacarbil in healthy adult, non-dependent, recreational drug 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?
- Alprazolam 2 mg, Gabapentin Enacarbil Immediate Release (GE-IR) 200 mg and Gabapentin Enacarbil Immediate Release (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
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2021to 30 Jun 2022
- 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 drug user who has used sedative drugs for recreational (nontherapeutic) purposes (i.e., for psychoactive effects) at least 10 times in the subject's lifetime and at least once in the 12 weeks before screening,
- Body mass index (BMI) within 18.0 kg/m^2 to 36.0 kg/m^2, 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 drug administration, during the study, and for at least 30 days after the last dose of the study drug. 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),
- 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 drug. 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/mL (mIU/mL) prior to the first study drug 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 the study medication, 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, as applicable, in the opinion of an investigator,
- Negative Coronavirus disease 2019 (Covid-19) test prior to each admission, as applicable.
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 anti-convulsants (e.g., alprazolam, carbamazepine) or related drugs (e.g., other benzodiazepines) 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, or alprazolam,
- 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 drug administration or planning to become pregnant within 30 days following the last study drug 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 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, as applicable, 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 drug administration (including e-cigarettes, pipes, cigars, chewing tobacco, nicotine topical patches, nicotine gum, or nicotine lozenges),
- 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 within 24 months 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 ≤60 ml/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 (HCV Ab) 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 drug 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 drug administration, with the exception of ibuprofen or acetaminophen,
- 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
About this study
Official title: A Randomized, Double Blind, Active and Placebo Controlled, 5 Way Crossover Study to Determine the Abuse Potential of Orally Administered Gabapentin Enacarbil Immediate Release Capsules in Healthy, Nondependent Recreational Drug Users With Sedative Experience
The purpose of this study is to assess the abuse potential of gabapentin enacarbil in healthy adult, non-dependent, recreational drug 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 in comparison to placebo and an active control with known abuse potential (i.e., alprazolam).
This study will be a randomized, double-blind, active- and placebo-controlled, 5-way crossover study to determine the abuse potential of gabapentin enacarbil immediate release (GE-IR) relative to alprazolam (active control) and placebo, in nondependent, recreational drug users with sedative drug use experience.
This study will consist of 3 phases: screening, qualification, and treatment.
- Conditions
- Abuse Potential
- Being tested
- Placebo, Alprazolam 2 mg, Gabapentin Enacarbil Immediate Release (GE-IR) 200 mg, Gabapentin Enacarbil Immediate Release (GE-IR) 450 mg, Gabapentin Enacarbil Immediate Release (GE-IR) 700 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo
Alprazolam 2 mgDrug
Also called Xanax
Oral dose of alprazolam 2 mg
Gabapentin Enacarbil Immediate Release (GE-IR) 200 mgDrug
Also called Horizant
Oral dose of GE-IR 200 mg
Gabapentin Enacarbil Immediate Release (GE-IR) 450 mgDrug
Also called Horizant
Oral dose of GE-IR 450 mg
Gabapentin Enacarbil Immediate Release (GE-IR) 700 mgDrug
Also called Horizant
Oral dose of GE-IR 700 mg
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | - Single oral dose Receives: Drug: Placebo |
| Alprazolam 2 mg | Active comparator | * Single oral dose
* Drug: Alprazolam 2 mg capsule Receives: Drug: Alprazolam 2 mg |
| GE-IR 200 mg | Experimental | * Single oral dose
* Drug: GE-IR 200 mg capsule Receives: Drug: Gabapentin Enacarbil Immediate Release (GE-IR) 200 mg |
| GE-IR 450 mg | Experimental | * Single oral dose
* Drug: GE-IR 450 mg capsule Receives: Drug: Gabapentin Enacarbil Immediate Release (GE-IR) 450 mg |
| GE-IR 700 mg | Experimental | * Single oral dose
* Drug: GE-IR 700 mg capsule Receives: Drug: Gabapentin Enacarbil Immediate Release (GE-IR) 700 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug Liking "at This Moment" 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.
- First posted24 Oct 2023
- Study start28 Sep 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbor Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097676
- Sponsor's protocol ID
- AR26.3031.1
- Status last verified
- Aug 2024
- First submitted
- 19 Oct 2023
- 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
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
- A Randomized, Double Blind, Active and Placebo Controlled, 5 Way Crossover Study to Determine the Abuse Potential of Orally Administered Gabapentin Enacarbil Immediate Release Capsules in Healthy, Nondependent Recreational Drug Users With Sedative Experience
- ClinicalTrials.gov ID
- NCT06097676
- Acronym / sponsor ID
- AR26.3031.1
- Conditions
- Abuse Potential
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Arbor Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 24 Oct 2023 (actual)
- Results
- Posted 3 Jan 2024
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 assess the abuse potential of gabapentin enacarbil in healthy adult, non-dependent, recreational drug users.
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 in comparison to placebo and an active control with known abuse potential (i.e., alprazolam).
This study will be a randomized, double-blind, active- and placebo-controlled, 5-way crossover study to determine the abuse potential of gabapentin enacarbil immediate release (GE-IR) relative to alprazolam (active control) and placebo, in nondependent, recreational drug users with sedative drug use experience.
This study will consist of 3 phases: screening, qualification, and treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo- Single oral dose |
| Alprazolam 2 mg | Active comparator | Drug: Alprazolam 2 mg* Single oral dose * Drug: Alprazolam 2 mg capsule |
| GE-IR 200 mg | Experimental | Drug: Gabapentin Enacarbil Immediate Release (GE-IR) 200 mg* Single oral dose * Drug: GE-IR 200 mg capsule |
| GE-IR 450 mg | Experimental | Drug: Gabapentin Enacarbil Immediate Release (GE-IR) 450 mg* Single oral dose * Drug: GE-IR 450 mg capsule |
| GE-IR 700 mg | Experimental | Drug: Gabapentin Enacarbil Immediate Release (GE-IR) 700 mg* Single oral dose * Drug: GE-IR 700 mg capsule |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 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 drug user who has used sedative drugs for recreational (nontherapeutic) purposes (i.e., for psychoactive effects) at least 10 times in the subject's lifetime and at least once in the 12 weeks before screening,
- Body mass index (BMI) within 18.0 kg/m^2 to 36.0 kg/m^2, inclusive,
Key exclusion criteria (23 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 anti-convulsants (e.g., alprazolam, carbamazepine) or related drugs (e.g., other benzodiazepines) 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, or alprazolam,
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 |
|---|---|---|
| PlaceboPlacebo | Drug | Placebo |
| Alprazolam 2 mgAlso: XanaxOral dose of alprazolam 2 mg | Drug | Alprazolam 2 mg |
| Gabapentin Enacarbil Immediate Release (GE-IR) 200 mgAlso: HorizantOral dose of GE-IR 200 mg | Drug | GE-IR 200 mg |
| Gabapentin Enacarbil Immediate Release (GE-IR) 450 mgAlso: HorizantOral dose of GE-IR 450 mg | Drug | GE-IR 450 mg |
| Gabapentin Enacarbil Immediate Release (GE-IR) 700 mgAlso: HorizantOral dose of GE-IR 700 mg | Drug | GE-IR 700 mg |
Primary outcome
Drug Liking "at This Moment" 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
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 Alprazolam 2 mg, Gabapentin Enacarbil Immediate Release (GE-IR) 200 mg and Gabapentin Enacarbil Immediate Release (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 15 inclusion and 23 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 3 Jan 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 "at This Moment" 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?
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.