Phase 4
Completed N=37
Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist
Attention Deficit Hyperactivity Disorder · Stimulant-Induced Euphoria
Source: ClinicalTrials.gov NCT01673594 ↗
Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcomePrimary: Change in Score on AISRS From Baseline to Week 6 — -26.7; -29.1 units on a scale
◆ Published Evidence
Emerging
11citations · ~1 / year
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.
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.
Linked Publications (2)
-
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.
-
The Mixed Opioid Receptor Antagonist Naltrexone Mitigates Stimulant-Induced Euphoria: A Double-Blind, Placebo-Controlled Trial of Naltrexone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Score on AISRS From Baseline to Week 6 |
-26.7; -29.1 | — |
| PRIMARY Safety |
6.73; 4.75 | — |
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- acute hepatitis or liver failure (baseline blood tests).
Data sourced from ClinicalTrials.gov (NCT01673594) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.