NCT00726960

Ability of Aprepitant to Block Opioid Reward in Non-Dependent Opiate Abusers

Modulation of Opiate Reward by NK1 Antagonism: A Laboratory-Based Proof of Concept Study

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine whether aprepitant blocks the opiate reward system in non-dependent opiate abusers, indicating its potential as a safe, non-addictive first line therapy for early heroin abuse.

Detailed description

This initial proof-of-concept study focuses on evaluating whether an NK1 antagonist, aprepitant, can block opiate reward in non-dependent opiate experienced volunteers in response to a standard opiate challenge. Sixty subjects will be included in a randomized controlled study. Following a training challenge session, they will receive 1 week treatment with aprepitant or matching placebo, followed by a challenge session during which subjective and physiological responses to the opiate partial agonist buprenorphine will be assessed.

Conditions

• Opioid-Related Disorders
• Heroin Dependence
• Substance-Related Disorders

Interventions

Type	Name	Description
DRUG	aprepitant	Oral, 125 mg once daily for one week
DRUG	Pseudo-placebo - buprenorphine	Randomized to receive either 8 mg sublingual tablets or 0.4 mg sublingual tablets

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-12-01
• Completion: 2010-06-01
• First posted: 2008-08-01
• Last updated: 2008-08-01

Locations

1 site across 1 country: Sweden