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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01873729
• Other study ID #: 2013P000696
• Status: Active, not recruiting
• Phase: Phase 4
• First received: May 6, 2013
• Last updated: March 14, 2016
• Start date: November 2013
• Est. completion date: April 2017

Study information

• Verified date: March 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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 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. We also plan to assess the effects of naltrexone on dopamine as measured by changes in serum prolactin. We predict that naltrexone will increase dopamine as indexed by decreases in serum prolactin.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Naltrexone
Adults with ADHD

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adult Investigator Symptom Rating Scale (AISRS)	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).	six weeks	No
Secondary	Clinical Global Impression (CGI)	The 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.	Six weeks	No