Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist

Study Overview
=================
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.

Official Title
-----------------
Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist

Conditions
-----------------
ADHD, Stimulant-Induced Euphoria

Intervention / Treatment
-----------------
* Drug: SODAS MPH
* Drug: Naltrexone


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naltrexone<br>Arm 1: Naltrexone + SODAS MPH | Drug: SODAS MPH<br>* Adults with ADHD will receive open-label SODAS MPH<br>* Other names: Ritalin LA;Drug: Naltrexone<br>* Subjects randomized to the active double-blind group will receive Naltrexone HCl<br>* Other names: Naltrexone HCl;|
| Placebo Comparator: Placebo<br>Arm 2: Placebo + SODAS MPH | Drug: SODAS MPH<br>* Adults with ADHD will receive open-label SODAS MPH<br>* Other names: Ritalin LA;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADHD, Adults, Naltrexone, SODAS MPH, Stimulant-Induced Euphoria, Substance Abuse