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

Sponsor

Karolinska University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00726960

Collaborator

Ministry of Health and Social Affairs, Sweden (Other), County of Stockholm (Other)

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid-Related Disorders Heroin Dependence Substance-Related Disorders	Drug: aprepitant Drug: Pseudo-placebo - buprenorphine	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2008

Anticipated Primary Completion Date :

Dec 1, 2009

Anticipated Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Aprepitant	Drug: aprepitant Oral, 125 mg once daily for one week Other Names: Emend
Placebo Comparator: 2 Placebo	Drug: Pseudo-placebo - buprenorphine Randomized to receive either 8 mg sublingual tablets or 0.4 mg sublingual tablets Other Names: Subutex

Arm

Intervention/Treatment

Experimental: 1

Aprepitant

Drug: aprepitant

Oral, 125 mg once daily for one week

Other Names:

Emend

Placebo Comparator: 2

Placebo

Drug: Pseudo-placebo - buprenorphine

Randomized to receive either 8 mg sublingual tablets or 0.4 mg sublingual tablets

Other Names:

Subutex

Outcome Measures

Primary Outcome Measures

The primary outcome will be self-reported pleasurable opiate effect. [One week]

Secondary Outcome Measures

The secondary outcome will be physiological opiate responses. [One week]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.