CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 29 enrolled
Drug / intervention
Entacapone +2 moredrug
Likely dose
Entacapone 200 mgfrom 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/NCT02058966
NCT02058966Early Ph 1Completed

Pilot Study of the Dose Response of Entacapone on Methamphetamine Induced Interest, Mood Elevation, and Reward

Oregon Health and Science University·interventional·Posted Feb 11, 2014·Updated Sep 12, 2019

In Brief

A Early Phase 1 clinical trial evaluating Entacapone, Methamphetamine, and 1 other intervention for Methamphetamine Dependence. Completed, enrolled 29 participants across 1 site.

Detailed Summary

Addiction to methamphetamine is a serious health problem. There are no medications that a doctor can give someone to help them stop using methamphetamine. Entacapone (Comtan©) is a medication that could help people addicted to methamphetamine. This study will see how entacapone works in healthy people who are given methamphetamine. We think that the study drug will be well tolerated, and that it will prevent some of the effects of methamphetamine that make it so addictive. We also want to see how differences in people's genes may cause differences in the ways the study drug and methamphetamine work for them. The study has six total visits. The first visit is for screening. Tests and procedures will make sure it is safe for subjects to participate. The second visit is a familiarization day. Subjects will receive methamphetamine, but no entacapone. This is done to make sure they can tolerate the drug and recognize its effects before being given a second drug on the same day. Subjects will take surveys and computer tests to see how the medications change mood, thinking, and liking the drug. The final four visits are the actual study days. Subjects will be randomly assigned (like the flip of a coin) to the different ways to get either 1) study medication or placebo (placebo contains no active study medication) and then 2) methamphetamine or placebo. Subjects will be in all four groups during the study, which means that each day a subject will get a different group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Early Ph 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 11, 2014
Enrollment StartJun 1, 2014
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 12.4 years ago

Interventions

Entacaponedrug

Entacapone 200 mg oral dose

Methamphetaminedrug

Methamphetamine 20 mg oral dose

Placebodrug

capsules compounded to be of similar appearance to the active drugs