Overview

This trial is active, not recruiting.

Conditions opioid-related disorders, heroin dependence, substance-related disorders
Treatments aprepitant, pseudo-placebo - buprenorphine
Phase phase 1
Sponsor Karolinska University Hospital
Collaborator Ministry of Health and Social Affairs, Sweden
Start date January 2008
End date December 2009
Trial size 60 participants
Trial identifier NCT00726960, Aprepitant 1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Aprepitant
aprepitant Emend
Oral, 125 mg once daily for one week
(Placebo Comparator)
Placebo
pseudo-placebo - buprenorphine Subutex
Randomized to receive either 8 mg sublingual tablets or 0.4 mg sublingual tablets

Primary Outcomes

Measure
The primary outcome will be self-reported pleasurable opiate effect.
time frame: One week

Secondary Outcomes

Measure
The secondary outcome will be physiological opiate responses.
time frame: One week

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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.

Additional Information

Official title Modulation of Opiate Reward by NK1 Antagonism: A Laboratory-Based Proof of Concept Study
Principal investigator Markus Heilig, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by Karolinska University Hospital.