Abuse PotentialPhase 4NCT04570436
Evaluating the Abuse Potential of NEURONTIN® When Taken Orally in Healthy Non-drug Dependent Participants With Sedative Drug Abuse Experience
A Phase 4 study testing gabapentin 600 mg, gabapentin 1200 mg and gabapentin 1800 mg in people with Abuse Potential, run by Viatris Specialty LLC at 1 site in United States.
Trial summary
This will be a randomized, double-blind, double-dummy, placebo- and active controlled, 5 treatment, 10 sequence, 5 period crossover single dose, Williams square design study in healthy adult, non drug dependent male and female participants with drug abuse experience with sedative drugs. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Abuse Potential
- What is being tested?
- gabapentin 600 mg, gabapentin 1200 mg and gabapentin 1800 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2021to 10 Nov 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female participants must be 18 to 65 years of age, inclusive, at the time of screening.
- Participants must meet reproductive criteria as outlined in the protocol.
- Male and female participants who are overtly healthy. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination, vital signs, 12-lead electrocardiogram (ECG), and/or clinical laboratory tests.
- Participants must be recreational sedative users, defined as those reporting using a sedative agent (eg, barbiturates, benzodiazepines) for its intoxicating effects on at least 10 lifetime occasions and at least once in the 12 weeks before the Screening Visit (Visit 1), but who have no signs of dependence and are not seeking treatment for their sedative use.
- Participants must satisfactorily complete both the Naloxone Challenge and the Drug Discrimination phases.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Body mass index (BMI) of 17.5 to 34 kg/m2, inclusive; and a total body weight >50 kg (110 lb).
- Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.
Who cannot join
- Participants with current or past diagnosis of any type of drug dependence within the past year. Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine) will be assessed by the Investigator using the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria performed at Screening. Current drug use will be allowed if the candidate can produce a negative urine sample and are free of any signs/symptoms of withdrawal. The candidate will be informed if they have a positive breathalyzer test.
- Participants are heavy smokers or users of other types of nicotine products (>20 cigarettes equivalents per day)
- Participants are unable to abstain from smoking for at least 2 hours before and at least 8 hours after study drug administration.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Participants with any history of sleep apnea, myasthenia or glaucoma.
- Any condition possibly affecting drug absorption (eg, gastrectomy) excluding cholecystectomy within 1 year prior to study.
Show all 26Show fewer
- Clinical or laboratory evidence of active hepatitis A infection or a history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C, and/or positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb).
- Participants with active suicidal ideation or suicidal behavior within 5 year prior to Screening as determined through the use of the Columbia-Suicide Severity Rating Scale (C-SSRS) or active ideation identified at Screening or on Day -1.
- Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product. (Refer to Section 6.5 for additional details).
- Herbal supplements and herbal medications must be discontinued at least 28 days prior to the first dose of study medication.
- Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives (whichever is longer) preceding the first dose of investigational product used in this study.
- Positive urine drug screen (UDS) for substances of abuse at each admission in Qualification and Treatment Phase, excluding tetrahydrocannabinol (THC). If a participant presents with a positive UDS excluding THC at any admission or any visit, the investigator, at his/her discretion, may reschedule a repeat UDS until the UDS is negative, excluding THC, before the participant is permitted to participate in any phase of the study.
- Participants unable to abstain from using THC during the Qualification and Treatment Phases of the study..
- Has participated in, is currently participating in, or is seeking treatment for substance-and/or alcohol-related disorders (excluding nicotine and caffeine).
- Has a positive alcohol breathalyzer test at Screening or upon admission to the study center at Visits 2-6. Positive results may be repeated and/or participants re-scheduled at the Investigator's discretions.
- Screening sitting BP >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of rest. If BP is >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility. Repeated BP tests should be spaced at least 5 minutes apart.
- Baseline (screening) 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline corrected QT (QTc) interval >450 msec, complete left bundle branch block [LBBB], signs of an acute or indeterminate-age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third-degree atrioventricular [AV] block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >450 msec, this interval should be rate-corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.
- Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed to be clinically significant in the opinion of the investigator:
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level >=1.5 × upper limit of normal (ULN);
- Total bilirubin level >=1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is <= ULN.
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
- History of hypersensitivity to gabapentin or diazepam or any of the components in the formulation of the study products.
- Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Sponsor employees, including their family members, directly involved in the conduct of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pharmaceutical Research Associates, Inc.
Salt Lake City, Utah, 84124
About this study
Official title: A Phase 4, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Single-dose, Five-way Crossover Study Evaluating the Abuse Potential of Three Doses of NEURONTIN® Taken Orally in Healthy, Non-drug Dependent Participants With Sedative Drug Abuse Experience
This will be a randomized, double-blind, double-dummy, placebo- and active controlled, 5 treatment, 10 sequence, 5 period crossover single dose, Williams square design study in healthy adult, non drug dependent male and female participants with drug abuse experience with sedative drugs.
Read the detailed description
The study includes Screening, a Qualification Phase consisting of a Naloxone Challenge and Drug Discrimination crossover study, a Treatment Phase and Follow-up. Following successful completion of the Qualification Phase the participants will be enrolled in the Treatment phase. The Treatment Phase is a randomized, double-blind, double dummy, placebo- and active controlled, 5 treatment, 10-sequence, 5 period crossover, single-dose, Williams square design study in healthy male and/or female adult, non drug-dependent recreational users. On Day 1 of each of the Treatment Phase 5 periods, which will be separated by a washout of at least 14 days, participants will receive an oral dose of either NEURONTIN® 1800 mg, 1200 mg or 600 mg or 20 mg diazepam, or placebo. Study treatments will be administered under fasted conditions (overnight fast and no food until 4 hours after dosing). Water will be allowed without restriction until 1 hour prior to dosing and 1 hour after dosing.
- Conditions
- Abuse Potential
- Being tested
- gabapentin 600 mg, gabapentin 1200 mg, gabapentin 1800 mg, diazepam 20 mg, placebo
- Keywords
- Neurontin, Diazepam, Abuse Liability, Gabapentin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gabapentin 600 mgDrug
participants will receive an oral dose of gabapentin 600 mg
gabapentin 1200 mgDrug
participants will receive an oral dose of gabapentin 1200 mg
gabapentin 1800 mgDrug
participants will receive an oral dose of gabapentin 1800 mg
diazepam 20 mgDrug
participants will receive an oral dose of 20 mg dose of diazepam
placeboOther
participants will receive an oral dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| gabapentin 600 mg | Experimental | single dose Receives: Drug: gabapentin 600 mg |
| diazepam 20 mg | Active comparator | single dose Receives: Drug: diazepam 20 mg |
| placebo | Placebo comparator | single dose Receives: Other: placebo |
| gabapentin 1200 mg | Experimental | single dose Receives: Drug: gabapentin 1200 mg |
| gabapentin 1800 mg | Experimental | single dose Receives: Drug: gabapentin 1800 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bipolar Visual Analog Scale (VAS) for "Drug Liking" Maximum Effect (Emax).
Drug liking assesses how much a participant likes or dislikes a drug effect at the time the question is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"
Measured: up to 72 hours after treatments
Secondary outcomes (17)
Bipolar VAS for "Drug Liking" (Time for Maximum Effect, Emax [TEmax])
Time after dosing when the maximum effect for Drug Liking VAS is reached
Measured: up to 72 hours after treatments
Bipolar VAS for "Drug Liking" (Area Under the Effect-time Profile From Time 0 to the Time of the Last Quantifiable Concentration [AUEClast])
Area under the effect-time profile from time 0 to the time of the last available data for the "Drug liking" visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question ("at this moment, my liking this drug is") is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking". The minimum and maximum possible scores are approximately 0 and 7200 if a subject scores 0 mm (strong disliking) and 100 mm (strong liking) respectively at every timepoint up to 72 hours.
Measured: Up to 72 hours after treatments (Assessments were made at the following timepoints after each treatment: 0, 0.25, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours)
Unipolar VAS for "High" (Maximum Effect, Emax)
Maximum effect on the 100 mm visual analog scale for the question "I am feeling high" where 0 = "not at all" and 100 ="extremely"
Measured: up to 72 hours after treatments
Unipolar VAS for "High" (Time for Maximum Effect, Emax [TEmax])
Time after dosing when the maximum effect for "High" VAS is reached
Measured: up to 72 hours after treatments
Unipolar VAS for "High" (Area Under the Effect-time Profile From Time 0 to the Time of the Last Quantifiable Concentration [AUEClast])
Area under the effect-time profile from time 0 to the time of the last available data for the "High" visual analog scale which measures on a 100 mm visual analog scale the subject's response to the question "I am feeling high" where 0 ="not at all" and 100 ="extremely". The minimum and maximum possible scores are 0 and approximately 7200 if a subject scores 0 mm (not at all) and 100 mm (extremely) respectively at every timepoint up to 72 hours.
Measured: Up to 72 hours after treatments (Assessments were made at the following timepoints after each treatment: 0, 0.25, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours)
Bipolar VAS for "Take Drug Again" at 24 Hour Post Dose
100 mm visual analog scale for the question "I would take this drug again" where 0 ="definitely not", 50 = "neutral", and 100 = "definitely so".
Measured: At 24 hours after treatment
Bipolar VAS for "Take Drug Again" at 36 Hour Post Dose
100 mm visual analog scale for the question "I would take this drug again" where 0 ="definitely not", 50 = "neutral", and 100 = "definitely so".
Measured: At 36 hours after treatment
Bipolar VAS for "Take Drug Again" at 48 Hour Post Dose
100 mm visual analog scale for the question "I would take this drug again" where 0 ="definitely not", 50 = "neutral", and 100 = "definitely so".
Measured: At 48 hours after treatment
Bipolar VAS for "Take Drug Again" at 72 Hour Post Dose
100 mm visual analog scale for the question "I would take this drug again" where 0 ="definitely not", 50 = "neutral", and 100 = "definitely so".
Measured: At 72 hours after treatment
Bipolar VAS for "Overall Drug Liking" at 24 Hour Post Dose
100 mm visual analog scale for the question "Overall, my liking for this drug is" where0 = "definitely not", 50 = "neutral", and 100 = "definitely so".
Measured: At 24 hours after treatment
Bipolar VAS for "Overall Drug Liking" at 36 Hour Post Dose
100 mm visual analog scale for the question "Overall, my liking for this drug is" where0 = "definitely not", 50 = "neutral", and 100 = "definitely so".
Measured: At 36 hours after treatment
Bipolar VAS for "Overall Drug Liking" at 48 Hour Post Dose
100 mm visual analog scale for the question "Overall, my liking for this drug is" where0 = "definitely not", 50 = "neutral", and 100 = "definitely so".
Measured: At 48 hours after treatment
Bipolar VAS for "Overall Drug Liking" at 72 Hour Post Dose
100 mm visual analog scale for the question "Overall, my liking for this drug is" where0 = "definitely not", 50 = "neutral", and 100 = "definitely so".
Measured: At 72 hours after treatment
Cmax of Gabapentin
Maximum plasma concentration (Cmax) of gabapentin
Measured: Up to 72 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours)
Tmax of Gabapentin
Time when the maximum concentration of gabapentin is reached
Measured: Up to 72 hours after treatments (concentrations were measured at the following timepoints after each treatment for thisoutcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 and 72 hours)
AUClast of Gabapentin
Area under the effect time profile from time 0 to the time of the last quantifiable concentration (AUClast) of gabapentin
Measured: up to 72 hours after treatment (concentrations were measured at the following timepoints after each treatment for thisoutcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 and 72 hours)
Terminal Half-life of Gabapentin
Terminal half-life (t½) of gabapentin
Measured: up to 72 hours after treatment (concentrations were measured at the following timepoints after each treatment for thisoutcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 and 72 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start29 Mar 2021
- Primary completion10 Nov 2022
- Study completion10 Nov 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viatris Specialty LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570436
- Sponsor's protocol ID
- A9451181
- Status last verified
- Jul 2024
- First submitted
- 24 Sep 2020
- Last updated
- 24 Jul 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 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Single-dose, Five-way Crossover Study Evaluating the Abuse Potential of Three Doses of NEURONTIN® Taken Orally in Healthy, Non-drug Dependent Participants With Sedative Drug Abuse Experience
- ClinicalTrials.gov ID
- NCT04570436
- Acronym / sponsor ID
- A9451181
- Conditions
- Abuse Potential
- Keywords
- Neurontin, Diazepam, Abuse Liability, Gabapentin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Viatris Specialty LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 30 Sep 2020 (actual)
- Results
- Posted 6 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a randomized, double-blind, double-dummy, placebo- and active controlled, 5 treatment, 10 sequence, 5 period crossover single dose, Williams square design study in healthy adult, non drug dependent male and female participants with drug abuse experience with sedative drugs.
Detailed description
The study includes Screening, a Qualification Phase consisting of a Naloxone Challenge and Drug Discrimination crossover study, a Treatment Phase and Follow-up. Following successful completion of the Qualification Phase the participants will be enrolled in the Treatment phase. The Treatment Phase is a randomized, double-blind, double dummy, placebo- and active controlled, 5 treatment, 10-sequence, 5 period crossover, single-dose, Williams square design study in healthy male and/or female adult, non drug-dependent recreational users. On Day 1 of each of the Treatment Phase 5 periods, which will be separated by a washout of at least 14 days, participants will receive an oral dose of either NEURONTIN® 1800 mg, 1200 mg or 600 mg or 20 mg diazepam, or placebo. Study treatments will be administered under fasted conditions (overnight fast and no food until 4 hours after dosing). Water will be allowed without restriction until 1 hour prior to dosing and 1 hour after dosing.
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 |
|---|---|---|
| gabapentin 600 mg | Experimental | Drug: gabapentin 600 mgsingle dose |
| diazepam 20 mg | Active comparator | Drug: diazepam 20 mgsingle dose |
| placebo | Placebo comparator | Other: placebosingle dose |
| gabapentin 1200 mg | Experimental | Drug: gabapentin 1200 mgsingle dose |
| gabapentin 1800 mg | Experimental | Drug: gabapentin 1800 mgsingle dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female participants must be 18 to 65 years of age, inclusive, at the time of screening.
- Participants must meet reproductive criteria as outlined in the protocol.
- Male and female participants who are overtly healthy. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination, vital signs, 12-lead electrocardiogram (ECG), and/or clinical laboratory tests.
- Participants must be recreational sedative users, defined as those reporting using a sedative agent (eg, barbiturates, benzodiazepines) for its intoxicating effects on at least 10 lifetime occasions and at least once in the 12 weeks before the Screening Visit (Visit 1), but who have no signs of dependence and are not seeking treatment for their sedative use.
- Participants must satisfactorily complete both the Naloxone Challenge and the Drug Discrimination phases.
Key exclusion criteria (26 listed)
- Participants with current or past diagnosis of any type of drug dependence within the past year. Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine) will be assessed by the Investigator using the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria performed at Screening. Current drug use will be allowed if the candidate can produce a negative urine sample and are free of any signs/symptoms of withdrawal. The candidate will be informed if they have a positive breathalyzer test.
- Participants are heavy smokers or users of other types of nicotine products (>20 cigarettes equivalents per day)
- Participants are unable to abstain from smoking for at least 2 hours before and at least 8 hours after study drug administration.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Participants with any history of sleep apnea, myasthenia or glaucoma.
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 |
|---|---|---|
| gabapentin 600 mgparticipants will receive an oral dose of gabapentin 600 mg | Drug | gabapentin 600 mg |
| gabapentin 1200 mgparticipants will receive an oral dose of gabapentin 1200 mg | Drug | gabapentin 1200 mg |
| gabapentin 1800 mgparticipants will receive an oral dose of gabapentin 1800 mg | Drug | gabapentin 1800 mg |
| diazepam 20 mgparticipants will receive an oral dose of 20 mg dose of diazepam | Drug | diazepam 20 mg |
| placeboparticipants will receive an oral dose of placebo | Other | placebo |
Primary outcome
Bipolar Visual Analog Scale (VAS) for "Drug Liking" Maximum Effect (Emax).
Time frame: up to 72 hours after treatments
Drug liking assesses how much a participant likes or dislikes a drug effect at the time the question is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"
17 secondary outcomes
Bipolar VAS for "Drug Liking" (Time for Maximum Effect, Emax [TEmax])
Time frame: up to 72 hours after treatments
Bipolar VAS for "Drug Liking" (Area Under the Effect-time Profile From Time 0 to the Time of the Last Quantifiable Concentration [AUEClast])
Time frame: Up to 72 hours after treatments (Assessments were made at the following timepoints after each treatment: 0, 0.25, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours)
Unipolar VAS for "High" (Maximum Effect, Emax)
Time frame: up to 72 hours after treatments
Unipolar VAS for "High" (Time for Maximum Effect, Emax [TEmax])
Time frame: up to 72 hours after treatments
Unipolar VAS for "High" (Area Under the Effect-time Profile From Time 0 to the Time of the Last Quantifiable Concentration [AUEClast])
Time frame: Up to 72 hours after treatments (Assessments were made at the following timepoints after each treatment: 0, 0.25, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours)
Bipolar VAS for "Take Drug Again" at 24 Hour Post Dose
Time frame: At 24 hours after treatment
Bipolar VAS for "Take Drug Again" at 36 Hour Post Dose
Time frame: At 36 hours after treatment
Bipolar VAS for "Take Drug Again" at 48 Hour Post Dose
Time frame: At 48 hours after treatment
Bipolar VAS for "Take Drug Again" at 72 Hour Post Dose
Time frame: At 72 hours after treatment
Bipolar VAS for "Overall Drug Liking" at 24 Hour Post Dose
Time frame: At 24 hours after treatment
Bipolar VAS for "Overall Drug Liking" at 36 Hour Post Dose
Time frame: At 36 hours after treatment
Bipolar VAS for "Overall Drug Liking" at 48 Hour Post Dose
Time frame: At 48 hours after treatment
Bipolar VAS for "Overall Drug Liking" at 72 Hour Post Dose
Time frame: At 72 hours after treatment
Cmax of Gabapentin
Time frame: Up to 72 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours)
Tmax of Gabapentin
Time frame: Up to 72 hours after treatments (concentrations were measured at the following timepoints after each treatment for thisoutcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 and 72 hours)
AUClast of Gabapentin
Time frame: up to 72 hours after treatment (concentrations were measured at the following timepoints after each treatment for thisoutcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 and 72 hours)
Terminal Half-life of Gabapentin
Time frame: up to 72 hours after treatment (concentrations were measured at the following timepoints after each treatment for thisoutcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 and 72 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 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 gabapentin 600 mg, gabapentin 1200 mg and gabapentin 1800 mg in people with Abuse Potential, run by Viatris Specialty LLC 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 8 inclusion and 26 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 Jul 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 6 Dec 2023). 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?
Bipolar Visual Analog Scale (VAS) for "Drug Liking" Maximum Effect (Emax). (time frame: up to 72 hours after treatments). 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 24 Jul 2024.