CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
Phendimetrazine +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02522325
NCT02522325Phase 1Completed
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Behavioral Effects of Drugs (Inpatient): 31 (Cocaine and Phendimetrazine)

William Stoops·interventional·Posted Aug 13, 2015·Updated Jul 2, 2019

In Brief

A Phase 1 clinical trial evaluating Phendimetrazine, Cocaine, and 1 other intervention for Cocaine Use Disorder. Completed, enrolled 30 participants across 1 site.

Detailed Summary

This study will determine the initial efficacy of phendimetrazine as a pharmacotherapy for cocaine dependence. A rigorous, inpatient human laboratory study will be conducted in which the subjective, physiological and reinforcing effects of cocaine are evaluated during maintenance on placebo and phendimetrazine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCocaine Use Disorder
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 13, 2015
Enrollment StartAug 1, 2015
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 10.9 years ago

Interventions

Phendimetrazinedrug

Phendimetrazine will be administered in divided doses twice daily.

Cocainedrug

Intranasal cocaine will be administered during experimental sessions.

Placebodrug

Placebo capsules will contain only cornstarch.