Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Double-Blind Comparison of Naltrexone and Placebo in Adults With Attention Deficit Hyperactivity Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Thomas J. Spencer, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01721330
First received: October 30, 2012
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

The primary aim of this study is to assess whether naltrexone as a monotherapy is effective in treating ADHD in adults. Medications that increase dopamine are often effective treatments for ADHD. Since naltrexone is a kappa opioid receptor antagonist, it increases dopamine in the brain. The investigators predict that naltrexone as a monotherapy will be effective for ADHD symptoms in adults with ADHD.

The investigators also plan to assess the effects of naltrexone on dopamine as measured by changes in serum prolactin. The investigators predict that naltrexone will increase dopamine as indexed by decreases in serum prolactin. This study will be a six-week, double-blind, placebo-controlled pilot study with adults 18-55 years of age with ADHD.


Condition Intervention Phase
ADHD
Attention Deficit Hyperactivity Disorder
Drug: Naltrexone
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind Comparison of Naltrexone and Placebo in Adults With Attention Deficit Hyperactivity Disorder

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Adult Investigator Symptom Rating Scale (AISRS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The 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).


Estimated Enrollment: 80
Study Start Date: November 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Naltrexone
Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.
Drug: Naltrexone
Placebo Comparator: Placebo
Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Male and female outpatients 18-55 years of age.
  2. Diagnosis of ADHD, by Diagnostic and Statistical Manual-IV (DSM-IV) by clinical evaluation by an expert clinician.
  3. A CGI of 7 (among the most extremely ill patients) at the pre-baseline visit is exclusionary, and any subject who presents a CGI-S of 7 at any point during the study will be removed from participation.
  4. Subjects presenting with a CGI-S 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.
  5. 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

  1. Any clinically unstable psychiatric conditions including any history of psychosis or mania, suicidality, sociopathy, criminality, or delinquency.
  2. Current (last 3 months) substance use disorders (alcohol or drugs),
  3. Medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study including cardiovascular disease, current untreated hypertension, or history of renal or hepatic impairment.
  4. A condition that will or may require treatment with opioid analgesics.
  5. Clinically significant abnormal baseline laboratory LFT's, which is defined as LFT's greater than the ULN.
  6. Mental retardation (IQ < 80).
  7. Organic brain disorders including delirium, dementia, seizures, stroke, neurosurgery, and head trauma with loss of consciousness.
  8. Pregnant or nursing females.
  9. Subjects with current adequate treatment for ADHD.
  10. Any other concomitant medication with primarily central nervous system activity other than specified in Concomitant Medication portion of the protocol (a stable and effective treatment regimen of an SSRI or benzodiazepine is permitted per clinical review).
  11. Non-English speaking subjects will not be allowed into the study for the following reasons:

    1. The assessment instruments are unavailable and have not been adequately standardized in other languages;
    2. Even if such translation services were available, the assessments in the English language conducted by English-speaking clinicians and raters with English-speaking subjects are already extremely time-consuming, lasting many hours, making it unfeasible, unrealistic, and of dubious clinical validity to conduct them with a translator with non-English-speaking subjects;
    3. Psychiatric questionnaires and evaluations are taxing, and adding the complexity of a translator has the potential to make the patient experience even more exhausting.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721330

Contacts
Contact: Jessica Abrams, BA 617-726-0142 jmabrams@mgh.harvard.edu
Contact: Leah Feinberg, BS 617-726-4651 lkfeinberg@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: Jessica Abrams, BA    617-726-0142    jmabrams@mgh.harvard.edu   
Contact: Leah Feinberg, BS    617-726-4651    lkfeinberg@mgh.harvard.edu   
Principal Investigator: Thomas J Spencer, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Thomas J Spencer, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Thomas J. Spencer, MD, Associate Chief, Clinical and Research Program, Pediatric Psychopharmacology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01721330     History of Changes
Other Study ID Numbers: 2012P-002252
Study First Received: October 30, 2012
Last Updated: August 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
ADHD
Attention Deficit Hyperactivity Disorder
Psychopharmacology
Psychiatry
Non-stimulant treatment

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Naltrexone
Central Nervous System Agents
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014