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Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist

NCT01673594 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2016-11-30

Study results available
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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.

Conditions

  • ADHD
  • Stimulant-Induced Euphoria

Interventions

DRUG

SODAS MPH

Adults with ADHD will receive open-label SODAS MPH

DRUG

Naltrexone

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

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Thomas J Spencer, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

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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 NCT01673594 on ClinicalTrials.gov