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Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist

This study has been completed.
United States Department of Defense
Information provided by (Responsible Party):
Thomas J. Spencer, MD, Massachusetts General Hospital Identifier:
First received: June 21, 2012
Last updated: October 7, 2016
Last verified: October 2016
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
Stimulant-Induced Euphoria
Drug: Naltrexone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in Score on AISRS From Baseline to Week 6 [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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
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
Adults with ADHD will receive open-label SODAS MPH
Other Name: Ritalin LA


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


  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


  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
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Please refer to this study by its identifier: NCT01673594

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

Responsible Party: Thomas J. Spencer, MD, Associate Chief, Clinical and Research Program, Pediatric Psychopharmacology, Massachusetts General Hospital Identifier: NCT01673594     History of Changes
Other Study ID Numbers: 2012-P-000918 
Study First Received: June 21, 2012
Results First Received: June 28, 2016
Last Updated: October 7, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Stimulant-Induced Euphoria
Substance Abuse

Additional relevant MeSH terms:
Narcotic Antagonists
Central Nervous System Stimulants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on January 18, 2017