Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist (NCT01673594) | Clinical Trial Compass
CompletedPhase 4
Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist
United States37 participantsStarted 2012-09
Plain-language summary
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.
Who can participate
Age range18 Years – 30 Years
SexALL
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Inclusion criteria
✓. Male and female outpatients
✓. age 18-30
✓. diagnosis of ADHD by DSM-IV, per clinical evaluation and confirmed by structured interview
✓. likeability response (\> 5) on Question #2 of the DRQ-S after an initial test dose of 60 mg of IR MPH.
✓. Baseline ADHD severity of \> 20 on the Adult ADHD Investigator System Report Scale (AISRS)
✓. Able to participate in blood draws and to swallow pills.
✓. Subjects must be considered reliable reporters, must understand the nature of the study and must sign an informed consent document
Exclusion criteria
✕. Any current (last month), non-ADHD Axis I psychiatric conditions
✕. Ham-D \> 16, BDI \> 19, or Ham-A \> 21
✕. Any clinically significant chronic medical condition