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

Phase 1

• Conditions: Heroin Dependence; Substance-Related Disorders; Opioid-Related Disorders
• Interventions: Drug: Pseudo-placebo - buprenorphine; Drug: aprepitant

• Registration Number: NCT00726960
• Lead Sponsor: Karolinska University Hospital

Brief 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.

Study Timeline

• Study Start: 2008-01
• Status Verified: 2008-07
• Study First Submitted: 2008-07-30
• Study First Submitted QC: 2008-07-30
• Last Update Submitted: 2008-07-30
• Study First Posted: 2008-08-01
• Last Update Posted: 2008-08-01
• Primary Completion: 2009-12
• Study Completion: 2010-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age 18 - 50
• Current opiate use, without dependence

Exclusion Criteria

• Clinical diagnosis of opiate dependence
• Positive urine screen for opiates on day of challenge sessions
• Meet diagnostic criteria for any other substance abuse disorder except nicotine within the last 12 months.
• Any ongoing prescription medication other than oral contraceptives or hormone replacement
• Any serious medical condition which in the judgment of the investigators makes administration of opiates medically inappropriate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	Pseudo-placebo - buprenorphine	Placebo
1	aprepitant	Aprepitant

Primary Outcome Measures

Name	Time	Method
The primary outcome will be self-reported pleasurable opiate effect.	One week

Secondary Outcome Measures

Name	Time	Method
The secondary outcome will be physiological opiate responses.	One week

Trial Locations

Locations (1)

Karolinska University Hospital, Huddinge; 🇸🇪 Stockholm, Sweden