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|
- Change in Adult Investigator Symptom Rating Scale (AISRS) Score [ 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). We measured the change in AISRS score from baseline to week 6.
|Study Start Date:||November 2012|
|Study Completion Date:||February 2015|
|Primary Completion Date:||February 2015 (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.
Up to 100mg of Naltrexone once a day for 6 weeks
Placebo Comparator: Placebo
Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.
Placebo twice a day for 6 weeks
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721330
|United States, Massachusetts|
|Massachusetts General Hospital|
|Cambridge, Massachusetts, United States, 02138|
|Principal Investigator:||Thomas J Spencer, MD||Massachusetts General Hospital|