Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist
1 other identifier
interventional
37
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Sep 2012
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2012
CompletedFirst Posted
Study publicly available on registry
August 28, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
November 30, 2016
CompletedNovember 30, 2016
October 1, 2016
2.7 years
June 21, 2012
June 28, 2016
October 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Score on AISRS From Baseline to Week 6
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
Number of adverse events throughout the course of the study
6 Weeks
Study Arms (2)
Naltrexone
EXPERIMENTALArm 1: Naltrexone + SODAS MPH
Placebo
PLACEBO COMPARATORArm 2: Placebo + SODAS MPH
Interventions
Adults with ADHD will receive open-label SODAS MPH
Subjects randomized to the "active" double-blind group will receive Naltrexone HCl
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (2)
Spencer TJ, Bhide P, Zhu J, Faraone SV, Fitzgerald M, Yule AM, Uchida M, Spencer AE, Hall AM, Koster AJ, Feinberg L, Kassabian S, Storch B, Biederman J. The Mixed Opioid Receptor Antagonist Naltrexone Mitigates Stimulant-Induced Euphoria: A Double-Blind, Placebo-Controlled Trial of Naltrexone. J Clin Psychiatry. 2018 Mar/Apr;79(2):17m11609. doi: 10.4088/JCP.17m11609.
PMID: 29617066DERIVEDSpencer TJ, Bhide P, Zhu J, Faraone SV, Fitzgerald M, Yule AM, Uchida M, Spencer AE, Hall AM, Koster AJ, Biederman J. Opiate Antagonists Do Not Interfere With the Clinical Benefits of Stimulants in ADHD: A Double-Blind, Placebo-Controlled Trial of the Mixed Opioid Receptor Antagonist Naltrexone. J Clin Psychiatry. 2018 Jan/Feb;79(1):16m11012. doi: 10.4088/JCP.16m11012.
PMID: 28640990DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Research Regulatory Coordinator
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas J Spencer, MD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Chief, Clinical and Research Program, Pediatric Psychopharmacology
Study Record Dates
First Submitted
June 21, 2012
First Posted
August 28, 2012
Study Start
September 1, 2012
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
November 30, 2016
Results First Posted
November 30, 2016
Record last verified: 2016-10