Naltrexone Clinical Trial
Official title:
Phase 1, Single-dose, Double-blind, Rand., Placebo- and Active-controlled, 4-period, 4-sequence Crossover, Proof-of-Concept Study to Evaluate Effect of Naltrexone on Abuse Potential of Methylphenidate in Healthy Recreational Stimulant Users
The current abuse liability study aims to assess the potential for co-administration of naltrexone (NTX) to reduce the abuse potential of methylphenidate (MPH).
The abuse of MPH, as a Schedule II substance, is a well-documented problem. Studies in animal models, including primates, show that high-dose MPH can produce reinforcement or reward. A number of studies suggest that the rapid elevation of MPH levels in the blood and brain that occurs following intranasal or oral administration of supra-therapeutic doses is a key requirement for development of MPH-associated euphoria, reinforcement, and addiction. The concerns about MPH abuse potential and addiction often play a role in the decision of patients, parents, or physicians who opt against treatment with MPH, despite its effectiveness. This provides an imperative for development of MPH formulations that are therapeutically potent but with lower abuse potential. Methylphenidate acts mainly through the dopaminergic system. At sufficiently high doses, MPH can also activate the mu opioid receptors (MOPR) in the brain. Recent data indicate that blockade of MOPRs by naltrexone (NTX) blocks the rewarding effects of MPH in mice. Clinical studies on the modulatory effect of NTX on dopamine release following chronic amphetamine use also support the involvement of opioid-dopamine interactions in the reinforcing and rewarding effects of amphetamine. These data support the hypothesis that NTX will block the reinforcing effect of MPH in humans. ;
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