Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, ADHD |
| Therapuetic Areas: | Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 18 - 30 |
| Updated: | 4/21/2016 |
| Start Date: | September 2012 |
| End Date: | June 2015 |
The purpose of this study is to a) assess the efficacy of naltrexone in preventing
stimulant-induced euphoria in adults with ADHD, b) assess whether naltrexone will interfere
with the clinical efficacy of stimulants in treating adults with ADHD, c) assess whether
naltrexone will interfere with the effects of stimulants on neurotransmitter activity. We
predict that naltrexone will successfully prevent stimulant-induced euphoria without
interfering with the ability of stimulants to effectively treat ADHD in adults. This study
will be an 8 -week trial with young adults (18-24) with ADHD.
stimulant-induced euphoria in adults with ADHD, b) assess whether naltrexone will interfere
with the clinical efficacy of stimulants in treating adults with ADHD, c) assess whether
naltrexone will interfere with the effects of stimulants on neurotransmitter activity. We
predict that naltrexone will successfully prevent stimulant-induced euphoria without
interfering with the ability of stimulants to effectively treat ADHD in adults. This study
will be an 8 -week trial with young adults (18-24) with ADHD.
Inclusion
1. Male and female outpatients
2. age 18-30
3. diagnosis of ADHD by DSM-IV, per clinical evaluation and confirmed by structured
interview
4. likeability response (> 5) on Question #2 of the DRQ-S after an initial test dose of
60 mg of IR MPH.
5. Baseline ADHD severity of > 20 on the Adult ADHD Investigator System Report Scale
(AISRS)
6. Able to participate in blood draws and to swallow pills.
7. Subjects must be considered reliable reporters, must understand the nature of the
study and must sign an informed consent document
Exclusion
1. Any current (last month), non-ADHD Axis I psychiatric conditions
2. Ham-D > 16, BDI > 19, or Ham-A > 21
3. Any clinically significant chronic medical condition
4. any cardiovascular disease or hypertension
5. Clinically significant abnormal baseline laboratory values
6. I.Q. < 80)
7. Organic brain disorders
8. Seizures or tics
9. Pregnant or nursing females
10. Clinically unstable psychiatric conditions (i.e. suicidal behaviors, psychosis)
11. Current or recent (within the past year) substance abuse/dependence
12. patients on other psychotropics
13. Current or prior adequate treatment with MPH
14. known hypersensitivity to methylphenidate
15. Current opioid use (by history and urine screen) or potential need for opioid
analgesics during the study
16. acute hepatitis or liver failure (baseline blood tests).
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