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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00726960

Enrollment

Registered

2008-08-01

Start date

2008-01-31

Completion date

2010-06-30

Last updated

2008-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heroin Dependence, Opioid-Related Disorders, Substance-Related Disorders

Keywords

Heroin abuse, Opioids, Opiates, Substance abuse, Addiction

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.

Interventions

DRUGaprepitant

Oral, 125 mg once daily for one week

DRUGPseudo-placebo - buprenorphine

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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.

Design outcomes

Primary

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

Secondary

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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026