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

Attention Deficit Hyperactivity Disorder Clinical Trial

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

Status Terminated

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 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.

Clinical Trial Description

This will be a six-week, randomized, double-blind, placebo-controlled, parallel design study of adult ADHD with naltrexone monotherapy. Eligible and consenting subjects will be recruited into the study. The first visit will consist of a meeting with a study clinician who obtains consent, assesses for eligibility, and completes study rating scales. After this evaluation, subjects will complete a neuropsychological assessment and study rating scales (two hours; this visit can take place over multiple days, if necessary). Subjects will then be randomized to naltrexone (50 mg) once a day with breakfast or placebo at a ratio of 1:1 to be increased, if tolerated, to 100 mg by week 1.

Blood will be drawn for prolactin, basic metabolic panel, CBC, and LFT's at pre-baseline and upon completion of the study. Ten cc's (approximately two teaspoons) of blood will be required for the basic metabolic panel, CBC, and LFT's at each drawing. An additional five cc's (approximately one teaspoon) of blood will be required for laboratory testing of prolactin levels at each drawing. Dipstick urine drug testing will be done at pre-baseline.

Women of child bearing age will also have a urine pregnancy test at pre-baseline.

Although every effort will be made to encourage subjects to keep regularly scheduled appointments, in the event that a subject is unable to come into the office within a reasonable timeframe of a scheduled visit, and the treating research clinician feels that subject safety will not be jeopardized by doing so, the clinician can conduct the visit with the subject over the telephone. However, study evaluation visit (pre-baseline), baseline visit, mid-point visit (week 3), or the final study visit may not be conducted over the phone. Additionally, phone visits may not occur for two consecutive visits. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

• NCT number: NCT01721330
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Terminated
• Phase: Phase 4
• Start date: November 2012
• Completion date: February 2015