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

Substance-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00726960
• Other study ID #: Aprepitant 1
• Status: Active, not recruiting
• Phase: Phase 1
• First received: July 30, 2008
• Last updated: July 30, 2008
• Start date: January 2008
• Est. completion date: June 2010

Study information

• Verified date: July 2008
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• aprepitant
Oral, 125 mg once daily for one week
• Pseudo-placebo - buprenorphine
Randomized to receive either 8 mg sublingual tablets or 0.4 mg sublingual tablets

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital, Huddinge	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska University Hospital	County of Stockholm, Ministry of Health and Social Affairs, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be self-reported pleasurable opiate effect.		One week	No
Secondary	The secondary outcome will be physiological opiate responses.		One week	No