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

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Drug: Naltrexone

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Adult Investigator Symptom Rating Scale (AISRS) Scores From Baseline	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).	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

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: May 6, 2013
• First Submitted That Met QC Criteria: June 6, 2013
• First Posted (Estimate): June 10, 2013

Study Record Updates

• Last Update Posted (Estimate): January 13, 2017
• Last Update Submitted That Met QC Criteria: November 16, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: ADHD; Adults; Naltrexone
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Alcohol Deterrents; Naltrexone
• Other Study ID Numbers: 2013P000696