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Determination the Abuse Potential of Pitolisant in Healthy, Non-Dependent Recreational Stimulant Users

NCT03152123 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2017-11-13

No results posted yet for this study

Summary

The purpose of this study is to assess the abuse potential of single doses of pitolisant relative to phentermine HCl and placebo, when administered to healthy, non-dependent, recreational stimulant users.

Conditions

  • Healthy
  • Drug Abuse

Interventions

DRUG

Pitolisant

Pitolisant 40 mg or 240 mg (tablets over-capsuled)

DRUG

Placebos

tablets over-capsuled

DRUG

Phentermine

Phentermine 60 mg (capsule over-capsuled)

Sponsors & Collaborators

Principal Investigators

  • Michael B. McDonnell, MD · Syneos Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-15
Primary Completion
2017-10-23
Completion
2017-10-23

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03152123 on ClinicalTrials.gov