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Completed

NCT Number: NCT01673594

Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Chemically-Induced Disorders Mental Disorders Neurodevelopmental Disorders Stimulant-Induced Euphoria Substance-Related Disorders

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion

  • Male and female outpatients
  • age 18-30
  • diagnosis of ADHD by DSM-IV, per clinical evaluation and confirmed by structured interview
  • likeability response (> 5) on Question #2 of the DRQ-S after an initial test dose of 60 mg of IR MPH.
  • Baseline ADHD severity of > 20 on the Adult ADHD Investigator System Report Scale (AISRS)
  • Able to participate in blood draws and to swallow pills.
  • Subjects must be considered reliable reporters, must understand the nature of the study and must sign an informed consent document

Exclusion

  • Any current (last month), non-ADHD Axis I psychiatric conditions
  • Ham-D > 16, BDI > 19, or Ham-A > 21
  • Any clinically significant chronic medical condition
  • any cardiovascular disease or hypertension
  • Clinically significant abnormal baseline laboratory values
  • I.Q. < 80)
  • Organic brain disorders
  • Seizures or tics
  • Pregnant or nursing females
  • Clinically unstable psychiatric conditions (i.e. suicidal behaviors, psychosis)
  • Current or recent (within the past year) substance abuse/dependence
  • patients on other psychotropics
  • Current or prior adequate treatment with MPH
  • known hypersensitivity to methylphenidate
  • Current opioid use (by history and urine screen) or potential need for opioid analgesics during the study
  • acute hepatitis or liver failure (baseline blood tests).

Treatment and study plan

SODAS MPH

Drug

Adults with ADHD will receive open-label SODAS MPH

Other names: Ritalin LA

Naltrexone

Drug

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

Other names: Naltrexone HCl

Primary outcomes

  1. Change in Score on AISRS From Baseline to Week 6

    Time frame: Baseline and 6 Weeks

    The Adult ADHD Investigator System Report Scale (AISRS) is an 18-item, DSM-IV symptom Likert scale that measures ADHD symptoms in adults. Each of the individual symptoms of ADHD is rated from 0 to 3 on a scale of severity (3 being more severe symptoms). Total scores range from 0 to 54; higher scores indicate greater symptom severity. Change was calculated as value at baseline minus value at 6 weeks.

  2. Safety

    Time frame: 6 Weeks

    Number of adverse events throughout the course of the study

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • United States Department of Defense

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 28, 2012
Registry last updated
Nov 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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