Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist

Phase 4

Completed

• Conditions: ADHD; Stimulant-Induced Euphoria
• Interventions: Drug: SODAS MPH; Drug: Naltrexone

• Registration Number: NCT01673594
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-21
• Study First Submitted QC: 2012-08-23
• Study First Posted: 2012-08-28
• Study Start: 2012-09
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2016-06-28
• Status Verified: 2016-10
• Results First Submitted QC: 2016-10-07
• Last Update Submitted: 2016-10-07
• Results First Posted: 2016-11-30
• Last Update Posted: 2016-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naltrexone	SODAS MPH	Arm 1: Naltrexone + SODAS MPH
Placebo	SODAS MPH	Arm 2: Placebo + SODAS MPH
Naltrexone	Naltrexone	Arm 1: Naltrexone + SODAS MPH

Primary Outcome Measures

Name	Time	Method
Change in Score on AISRS From Baseline to Week 6	Baseline and 6 Weeks	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.
Safety	6 Weeks	Number of adverse events throughout the course of the study

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States