CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 37 enrolled
Drug / intervention
SODAS MPH +1 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/NCT01673594
NCT01673594Phase 4Completed
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Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist

Massachusetts General Hospital·interventional·Posted Aug 28, 2012·Updated Nov 30, 2016

In Brief

A Phase 4 clinical trial evaluating SODAS MPH and Naltrexone for ADHD and Stimulant-Induced Euphoria. Completed, enrolled 37 participants across 1 site.

Detailed Summary

The purpose of this study is to a) assess the efficacy of naltrexone in preventing stimulant-induced euphoria in adults with ADHD, b) assess whether naltrexone will interfere with the clinical efficacy of stimulants in treating adults with ADHD, c) assess whether naltrexone will interfere with the effects of stimulants on neurotransmitter activity. We predict that naltrexone will successfully prevent stimulant-induced euphoria without interfering with the ability of stimulants to effectively treat ADHD in adults. This study will be an 8 -week trial with young adults (18-24) with ADHD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsADHD, Stimulant-Induced Euphoria
CountriesUnited States
CollaboratorsUnited States Department of Defense

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 28, 2012
Enrollment StartSep 1, 2012
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 13.8 years ago

Interventions

SODAS MPHdrug

Adults with ADHD will receive open-label SODAS MPH

Naltrexonedrug

Subjects randomized to the "active" double-blind group will receive Naltrexone HCl