Text Size

Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist

This study is currently recruiting participants.
Verified April 2013 by Massachusetts General Hospital
Sponsor:
Collaborator:
Department of Defense
Information provided by (Responsible Party):
Thomas J. Spencer, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01673594
First received: June 21, 2012
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  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 Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
    Efficacy (positive, or 'liking' response to stimulant medication) will be assessed by the change in the Drug Rating Questionnaire - Subject (DRQ-S).


Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 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

Ages Eligible for Study:   18 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion

  1. Male or female adults ages 18-30 years.
  2. A diagnosis of ADHD, per clinical evaluation
  3. At least a minimal likeability response (> 5) on the DRQ-S after an initial test dose of 60mg of IR MPH.
  4. Baseline ADHD severity of > 24 on the AISRS.
  5. Able to participate in blood draws and to swallow pills.
  6. Able to understand the nature of the study, to sign an informed consent document and to be considered reliable reporters

Exclusion

  1. Any current (last month), non-ADHD Axis I psychiatric conditions
  2. Significant current anxiety or depression based on Ham-D > 16, BDI > 19, or Ham-A > 21
  3. Any clinically significant chronic medical condition, including cardiovascular disease or hypertension
  4. Clinically significant abnormal baseline laboratory values
  5. I.Q. < 80
  6. Organic brain disorders
  7. Seizures or tics
  8. Pregnant or nursing females
  9. Clinically unstable psychiatric conditions (i.e. suicidal behaviors, psychosis)
  10. Current or recent (within the past year) substance abuse/dependence
  11. Current use of other psychotropic medication(s)
  12. Current or prior adequate treatment with MPH
  13. Known hypersensitivity to methylphenidate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673594

Contacts
Contact: Katie McDermott, B.S. 617-503-1008 kmmcdermott@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Ariana Koster     617-724-2858     AKOSTER@PARTNERS.org    
Sponsors and Collaborators
Massachusetts General Hospital
Department of Defense
Investigators
Principal Investigator: Thomas J Spencer, MD Massachusetts General Hospital
  More Information

No publications provided

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
Study First Received: June 21, 2012
Last Updated: April 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
ADHD
Naltrexone
SODAS MPH
 Stimulant-Induced Euphoria
Substance Abuse
Adults

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Naltrexone
Narcotic Antagonists
 Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013