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Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01673594
First Posted: August 28, 2012
Last Update Posted: November 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Thomas J. Spencer, MD, Massachusetts General Hospital
  Purpose
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.

Condition Intervention Phase
ADHD Stimulant-Induced Euphoria Drug: SODAS MPH Drug: Naltrexone Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist

Resource links provided by NLM:


Further study details as provided by Thomas J. Spencer, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.

  • Safety [ Time Frame: 6 Weeks ]
    Number of adverse events throughout the course of the study


Enrollment: 37
Study Start Date: September 2012
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Naltrexone
Arm 1: Naltrexone + SODAS MPH
Drug: SODAS MPH
Adults with ADHD will receive open-label SODAS MPH
Other Name: Ritalin LA
Drug: Naltrexone
Subjects randomized to the "active" double-blind group will receive Naltrexone HCl
Other Name: Naltrexone HCl
Placebo Comparator: Placebo
Arm 2: Placebo + SODAS MPH
Drug: SODAS MPH
Adults with ADHD will receive open-label SODAS MPH
Other Name: Ritalin LA

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673594


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
United States Department of Defense
Investigators
Principal Investigator: Thomas J Spencer, MD Massachusetts General Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas J. Spencer, MD, Associate Chief, Clinical and Research Program, Pediatric Psychopharmacology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01673594     History of Changes
Other Study ID Numbers: 2012-P-000918
First Submitted: June 21, 2012
First Posted: August 28, 2012
Results First Submitted: June 28, 2016
Results First Posted: November 30, 2016
Last Update Posted: November 30, 2016
Last Verified: October 2016

Keywords provided by Thomas J. Spencer, MD, Massachusetts General Hospital:
ADHD
Naltrexone
SODAS MPH
Stimulant-Induced Euphoria
Substance Abuse
Adults

Additional relevant MeSH terms:
Naltrexone
Narcotic Antagonists
Central Nervous System Stimulants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents