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

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ClinicalTrials.gov Identifier: NCT01873729
Recruitment Status : Completed
First Posted : June 10, 2013
Results First Posted : September 20, 2016
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
Thomas J. Spencer, MD, Massachusetts General Hospital

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.


Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: Naltrexone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study of Naltrexone in Adults With Attention Deficit Hyperactivity Disorder.
Study Start Date : November 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016


Arm Intervention/treatment
Experimental: Naltrexone
Naltrexone
Drug: Naltrexone
Adults with ADHD




Primary Outcome Measures :
  1. Change in Adult Investigator Symptom Rating Scale (AISRS) Scores From Baseline [ Time Frame: Baseline and Six weeks ]
    The 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).


Secondary Outcome Measures :
  1. Clinical Global Impression (CGI) [ Time Frame: Six weeks ]
    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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873729


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Thomas Spencer, MD Massachusetts General Hospital

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Responsible Party: Thomas J. Spencer, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01873729     History of Changes
Other Study ID Numbers: 2013P000696
First Posted: June 10, 2013    Key Record Dates
Results First Posted: September 20, 2016
Last Update Posted: January 13, 2017
Last Verified: November 2016

Keywords provided by Thomas J. Spencer, MD, Massachusetts General Hospital:
ADHD
Naltrexone
Adults

Additional relevant MeSH terms:
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Hyperkinesis
Disease
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Naltrexone
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents