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An Open-Label Study of Naltrexone in Adults With Attention Deficit Hyperactivity Disorder.

ClinicalTrials.gov ID NCT01873729
Sponsor Massachusetts General Hospital
Information provided by Thomas J. Spencer, MD, Massachusetts General Hospital (Responsible Party)
Last Update Posted 2017-01-13
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Study Overview

Brief Summary

The primary aim of this study is to assess whether naltrexone as a monotherapy is effective in treating Attention Deficit Hyperactivity Disorder (ADHD) in adults. Medications that increase dopamine are often effective in treating ADHD in adults. Since naltrexone is a kappa opioid receptor antagonist, it increases dopamine in the brain.

We predict that naltrexone as a monotherapy will be effective for ADHD symptoms in adults with ADHD.

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Official Title
An Open-Label Study of Naltrexone in Adults With Attention Deficit Hyperactivity Disorder.
Conditions
Attention Deficit Hyperactivity Disorder
Intervention / Treatment
  • Drug: Naltrexone
  • Drug: Naltrexone
Other Study ID Numbers
  • 2013P000696
Study Start
2013-11
Primary Completion (Actual)
2016-06
Study Completion (Actual)
2016-06
Enrollment (Actual)
3
Study Type
Interventional
Phase
Phase 4

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

This study has 1 location
United States
Massachusetts Locations
Boston, Massachusetts, United States, 02114

Massachusetts General Hospital
Click to view interactive map

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

Inclusion Criteria

  • Male and female outpatients 18-55 years of age.
  • Diagnosis of ADHD, by DSM-IV by clinical evaluation by an expert clinician.
  • Subjects treated for anxiety disorders and depression who are on a stable medication regimen for at least one month, and who have a disorder-specific CGI-Severity score ≤ 3 (mildly ill) and who have a score on the Hamilton-Depression and Hamilton-Anxiety rating scales below 15 (mild range).

Exclusion Criteria

  • Any clinically unstable psychiatric conditions including any history of psychosis or mania, suicidality, sociopathy, criminality, or delinquency.
  • Current (last 3 months) substance use disorders (alcohol or drugs),
  • Medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study including cardiovascular disease, current untreated hypertension, history of renal or hepatic impairment, or a condition that will or may require treatment with opioid analgesics.
  • Clinically significant abnormal baseline laboratory LFT's, which is defined as LFT's greater than the ULN.
  • Mental retardation (IQ < 80).
  • Organic brain disorders including delirium, dementia, seizures, stroke, neurosurgery, and head trauma with loss of consciousness.
  • Pregnant or nursing females.
  • Subjects with current adequate treatment for ADHD.
  • Current treatment with medication for ADHD.
  • Any other concomitant medication with primarily central nervous system activity other than specified in the protocol (a stable and effective treatment regimen of an SSRI or benzodiazepine is permitted per clinical review.)
  • A Clinical Global Impression (CGI) of 7 (among the most extremely ill patients) at the screening visit is exclusionary, and any subject who presents a CGI-S of 7 at any point during the study will be removed from participation.
  • Subjects presenting with a CGI-Severity score of 6 (severely ill) at two consecutive visits after week 2 will be dropped from the study (i.e. A subject with a CGI of 6 at his/her week 3 visit and at week 4 visit will be dropped from the study at the week 4 visit). Subjects who are dropped for severe or worsening symptoms after exposure to the study medication will receive free follow up care as described in the detailed protocol and protocol summary.
  • Non-English speaking subjects
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Ages Eligible for Study
18 Years to 55 Years (Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

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

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Design Details
Primary Purpose : Treatment
Allocation : N/A
Interventional Model : Single Group Assignment
Masking : None (Open Label)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Experimental: Naltrexone
Naltrexone
Intervention/Treatment Drug: Naltrexone
  • Adults with ADHD

Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Change in Adult Investigator Symptom Rating Scale (AISRS) Scores From BaselineThe Adult Investigator Symptom Rating Scale (AISRS) is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (none) to 3 (severe). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms).Baseline and Six weeks
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
Clinical Global Impression (CGI)The Clinical Global Impression (CGI) scale allows the clinician to rate the severity of illness, change over time, and efficacy of medication, taking into account the patient's clinical condition and the severity of side effects. The CGI subscales include the Clinical Global Severity of ADHD (CGI-S) which is scored on a 7 point scale (1=not ill, 7=extremely ill) and the Clinical Global Improvement of ADHD (CGI-I) which is also scored on a 7 point scale (1=very much improved, 7=very much worse). The number of subjects with CGI-Improvement scores less than or equal to 2 (very much improved) at the end of the study is reported.Six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Massachusetts General Hospital
Investigators
  • Principal Investigator:Thomas Spencer, MD,Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2013-05-06
First Submitted that Met QC Criteria
2013-06-06
First Posted (Estimated)
2013-06-10
Results Reporting Dates
Results First Submitted
2016-07-29
Results First Submitted that Met QC Criteria
2016-07-29
Results First Posted (Estimated)
2016-09-20
Study Record Updates
Last Update Submitted that met QC Criteria
2016-11-16
Last Update Posted (Estimated)
2017-01-13
Last Verified
2016-11

More Information

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Keywords Provided by Thomas J. Spencer, MD, Massachusetts General Hospital
Additional Relevant MeSH Terms