Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist
NCT ID: NCT01673594
Last Updated: 2016-11-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
37 participants
INTERVENTIONAL
2012-09-30
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Naltrexone
Arm 1: Naltrexone + SODAS MPH
SODAS MPH
Adults with ADHD will receive open-label SODAS MPH
Naltrexone
Subjects randomized to the "active" double-blind group will receive Naltrexone HCl
Placebo
Arm 2: Placebo + SODAS MPH
SODAS MPH
Adults with ADHD will receive open-label SODAS MPH
Interventions
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SODAS MPH
Adults with ADHD will receive open-label SODAS MPH
Naltrexone
Subjects randomized to the "active" double-blind group will receive Naltrexone HCl
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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).
18 Years
30 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Massachusetts General Hospital
OTHER
Responsible Party
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Thomas J. Spencer, MD
Associate Chief, Clinical and Research Program, Pediatric Psychopharmacology
Principal Investigators
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Thomas J Spencer, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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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.
Spencer 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.
Other Identifiers
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2012-P-000918
Identifier Type: -
Identifier Source: org_study_id