drugset / Trial / NCT01673594
Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist
Phase 4
Completed
37 enrolled
Massachusetts General Hospital
United States Department of Defense · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2012-09
- Primary completion
- 2015-06
- Completion
- 2015-06
Publications
- Spencer TJ, Bhide P, Zhu J, Faraone SV, Fitzgerald M, Yule AM, Uchida M, Spencer AE, Hall AM, Koster AJ, Feinberg L, Kassabian S, Storch B, Biederman J. The Mixed Opioid Receptor Antagonist Naltrexone Mitigates Stimulant-Induced Euphoria: A Double-Blind, Placebo-Controlled Trial of Naltrexone. J Clin Psychiatry. 2018 Mar/Apr;79(2):17m11609. doi: 10.4088/JCP.17m11609.
- Spencer TJ, Bhide P, Zhu J, Faraone SV, Fitzgerald M, Yule AM, Uchida M, Spencer AE, Hall AM, Koster AJ, Biederman J. Opiate Antagonists Do Not Interfere With the Clinical Benefits of Stimulants in ADHD: A Double-Blind, Placebo-Controlled Trial of the Mixed Opioid Receptor Antagonist Naltrexone. J Clin Psychiatry. 2018 Jan/Feb;79(1):16m11012. doi: 10.4088/JCP.16m11012.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylphenidate | Small molecule | 1 mg/kg | — |
| Subject | Naltrexone | Small molecule | 50 mg | — |