A Double-Blind Comparison of Naltrexone and Placebo 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 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.
Attention Deficit Hyperactivity Disorder
|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|
- 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).
|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)|
Active Comparator: Naltrexone
Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.
Placebo Comparator: Placebo
Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721330
|Contact: Jessica Abrams, BAfirstname.lastname@example.org|
|Contact: Leah Feinberg, BSemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Cambridge, Massachusetts, United States, 02138|
|Contact: Jessica Abrams, BA 617-726-0142 firstname.lastname@example.org|
|Contact: Leah Feinberg, BS 617-726-4651 email@example.com|
|Principal Investigator: Thomas J Spencer, MD|
|Principal Investigator:||Thomas J Spencer, MD||Massachusetts General Hospital|