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

• Status: Not yet recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Diazepam; Gabapentin

Criteria

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.