Evaluating the Abuse Potential of Neurontin® When Taken Orally in Healthy Non-drug Dependent Participants With Sedative Drug Abuse Experience

NCT04570436

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Abuse Potential
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male and female participants who are overtly healthy.

- Participants must be recreational sedative users.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Participants with current or past diagnosis of any type of drug dependence within the
past year.


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluating the Abuse Potential of Neurontin® When Taken Orally in Healthy Non-drug Dependent Participants With Sedative Drug Abuse Experience
Official Title  ICMJE 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(REGISTERED) TAKEN ORALLY IN HEALTHY, NON-DRUG DEPENDENT PARTICIPANTS WITH SEDATIVE DRUG ABUSE EXPERIENCE
Brief 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.
Detailed Description The study includes Screening, a Qualification Phase consisting of a Naloxone Challenge and 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Abuse Potential
Intervention  ICMJE
  • Drug: gabapentin 600 mg
    participants will receive an oral dose of gabapentin 600 mg
  • Drug: gabapentin 1200 mg
    participants will receive an oral dose of gabapentin 1200 mg
  • Drug: gabapentin 1800 mg
    participants will receive an oral dose of gabapentin 1800 mg
  • Drug: diazepam 20 mg
    participants will receive an oral dose of 20 mg dose of diazepam
  • Other: placebo
    participants will receive an oral dose of placebo
Study Arms  ICMJE
  • Experimental: gabapentin 600 mg
    single dose
    Intervention: Drug: gabapentin 600 mg
  • Active Comparator: diazepam 20 mg
    single dose
    Intervention: Drug: diazepam 20 mg
  • Placebo Comparator: placebo
    single dose
    Intervention: Other: placebo
  • Experimental: gabapentin 1200 mg
    single dose
    Intervention: Drug: gabapentin 1200 mg
  • Experimental: gabapentin 1800 mg
    single dose
    Intervention: Drug: gabapentin 1800 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 24, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female participants who are overtly healthy.
  • Participants must be recreational sedative users.

Exclusion Criteria:

  • Participants with current or past diagnosis of any type of drug dependence within the past year.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04570436
Other Study ID Numbers  ICMJE A9451181
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP