Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist

October 7, 2016 updated by: Thomas J. Spencer, MD, Massachusetts General Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion

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

Exclusion

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Naltrexone
Arm 1: Naltrexone + SODAS MPH
Drug: SODAS MPH
Adults with ADHD will receive open-label SODAS MPH
Other Names:
  • Ritalin LA
Drug: Naltrexone
Subjects randomized to the "active" double-blind group will receive Naltrexone HCl
Other Names:
  • Naltrexone HCl
Placebo Comparator: Placebo
Arm 2: Placebo + SODAS MPH
Drug: SODAS MPH
Adults with ADHD will receive open-label SODAS MPH
Other Names:
  • Ritalin LA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 6 Weeks
Safety
Time Frame: 6 Weeks
Number of adverse events throughout the course of the study
6 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Thomas J Spencer, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 21, 2012

First Submitted That Met QC Criteria

August 23, 2012

First Posted (Estimate)

August 28, 2012

Study Record Updates

Last Update Posted (Estimate)

November 30, 2016

Last Update Submitted That Met QC Criteria

October 7, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-P-000918

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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