Modulation of opiate reward by NK1 antagonism: A laboratory based proof of concept study

Phase 1

• Conditions: opiate abuse; MedDRA version: 9.1Level: LLTClassification code 10039004Term: Reversal of opiate activity; MedDRA version: 9.1Level: LLTClassification code 10012346Term: Dependence on opiates

• Registration Number: EUCTR2007-004912-30-SE
• Lead Sponsor: Karolinska Institutet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-12
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Subjects will be eligible if they are aged 18 – 50 years and have current opiate use
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subject will not be eligible if they

-currently meet criteria for opiate dependence.
-have a positive urine screen for opiates
-meet criteria for any other substance dependence disorder except nicotine within the last 12 months
-have any ongoing prescription medication other than oral contraceptives or hormone replacement
-have any serious medical condition which in the judgment of the investigators makes administration of opiates medically inappropriate.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the NK1 antagonist aprepitant for its ability to block physiological and psychological effects of opiate receptor activation;Secondary Objective: ;Primary end point(s): Subjective psychological responses to opiate challene