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Anti-epileptic drug

gabapentin 1800 mg for Substance Abuse

Phase 4
Waitlist Available
Research Sponsored by Viatris Specialty LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 24 hours after treatment
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a new sedative drug in healthy adults with a history of drug abuse.

Eligible Conditions
  • Substance Abuse

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 24 hours after treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 24 hours after treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bipolar Visual Analog Scale (VAS) for "Drug Liking" Maximum Effect (Emax).
Secondary outcome measures
AUClast of Gabapentin
Bipolar VAS for "Drug Liking" (Area Under the Effect-time Profile From Time 0 to the Time of the Last Quantifiable Concentration [AUEClast])
Bipolar VAS for "Drug Liking" (Time for Maximum Effect, Emax [TEmax])
+14 more

Side effects data

From 2022 Phase 4 trial • 52 Patients • NCT04570436
20%
Somnolence
10%
Dizziness
8%
Euphoric mood
6%
Depressed level of consciousness
6%
Headache
4%
Fatigue
4%
Lethargy
4%
Feeling of relaxation
2%
Nausea
2%
Visual impairment
2%
Scleral disorder
2%
Anxiety
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gabapentin 1800 mg
Placebo
Diazepam 20 mg
Gabapentin 1200 mg
Gabapentin 600 mg

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: gabapentin 600 mgExperimental Treatment1 Intervention
single dose
Group II: gabapentin 1800 mgExperimental Treatment1 Intervention
single dose
Group III: gabapentin 1200 mgExperimental Treatment1 Intervention
single dose
Group IV: diazepam 20 mgActive Control1 Intervention
single dose
Group V: placeboPlacebo Group1 Intervention
single dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
gabapentin 600 mg
2021
Completed Phase 4
~110
gabapentin 1200 mg
2021
Completed Phase 4
~110
gabapentin 1800 mg
2021
Completed Phase 4
~60

Find a Location

Who is running the clinical trial?

Viatris Specialty LLCLead Sponsor
2 Previous Clinical Trials
114 Total Patients Enrolled
PfizerLead Sponsor
4,570 Previous Clinical Trials
10,915,974 Total Patients Enrolled
1 Trials studying Substance Abuse
45,000 Patients Enrolled for Substance Abuse
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,476 Previous Clinical Trials
8,092,169 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment permit participation from those aged sixty or above?

"This clinical trial has an age restriction of 18 to 65 years old and is currently recruiting patients who meet the criteria."

Answered by AI

How can I become involved in this clinical experiment?

"Qualifying individuals for this clinical trial must have a history of drug misuse and be between the ages of 18 to 65. This study is aiming to select 40 participants in total."

Answered by AI

What ailments are remedied by a dosage of gabapentin 1800 mg?

"Gabapentin 1800 mg is frequently employed to address sedation, as well as neuralgia, athetosis, and refractory epilepsy."

Answered by AI

Has the Food and Drug Administration given sign-off on a gabapentin dosage of 1800 mg?

"There is a significant amount of evidence that gabapentin 1800 mg meets safety requirements, so it was assigned the highest score of 3."

Answered by AI

How many participants are participating in this medical investigation?

"That is correct. The research team has taken to clinicaltrials.gov in order to post the details of this medical trial, which was initially made public on March 29th 2021 and updated as recently as March 8th 2022. Forty participants are being recruited from a single centre."

Answered by AI

Are there any opportunities to volunteer for this research endeavor?

"Affirmative. According to clinicaltrials.gov, the trial was launched on March 29th 2021 and is currently recruiting participants. 40 individuals are sought from 1 medical site for this investigation."

Answered by AI

What research has been done regarding the effects of a gabapentin 1800 mg dosage?

"Currently, there are 29 clinical trials assessing the efficacy of gabapentin 1800 mg. Out of these studies, 9 are in their final phase; Phase 3. While Columbus, Ohio is where most experiments occur, this medicinal research spans 85 distinct locations globally."

Answered by AI

Who else is applying?

What state do they live in?
Oregon
How old are they?
18 - 65
What site did they apply to?
Pharmaceutical Research Associates, Inc.
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Evaluating the Abuse Potential of NEURONTIN® When Taken Orally in Healthy Non-drug Dependent Participants With Sedative Drug Abuse Experience
2021. "Evaluating the Abuse Potential of NEURONTIN® When Taken Orally in Healthy Non-drug Dependent Participants With Sedative Drug Abuse Experience". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04570436.
~13 spots leftby Apr 2025
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