An Open-Label Study of Naltrexone in Adults With Attention Deficit Hyperactivity Disorder.
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|ClinicalTrials.gov Identifier: NCT01873729|
Recruitment Status : Completed
First Posted : June 10, 2013
Results First Posted : September 20, 2016
Last Update Posted : January 13, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Drug: Naltrexone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Study of Naltrexone in Adults With Attention Deficit Hyperactivity Disorder.|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Adults with ADHD
- Change in Adult Investigator Symptom Rating Scale (AISRS) Scores From Baseline [ Time Frame: Baseline and Six weeks ]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).
- Clinical Global Impression (CGI) [ Time Frame: Six weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873729
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Thomas Spencer, MD||Massachusetts General Hospital|