Completed

Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist

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What is being tested

SODAS MPH

+ Naltrexone

+ SODAS MPH

Drug
Who is being recruted

Mental Disorders+3

+ Attention Deficit and Disruptive Behavior Disorders

+ Chemically-Induced Disorders

From 18 to 30 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorMassachusetts General Hospital
Last updated: November 30, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorMassachusetts General Hospital
Last updated: November 30, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

37 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 30 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersAttention Deficit and Disruptive Behavior DisordersChemically-Induced DisordersNeurodevelopmental DisordersAttention Deficit Disorder with HyperactivitySubstance-Related Disorders

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).

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Arm 1: Naltrexone + SODAS MPH

Group II

Placebo
Arm 2: Placebo + SODAS MPH

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Massachusetts General Hospital

Boston, United StatesOpen Massachusetts General Hospital in Google Maps
CompletedOne Study Center