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

NCT ID: NCT00726960

Last Updated: 2008-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-06-30

Brief Summary

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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

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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.

Conditions

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Opioid-Related Disorders Heroin Dependence Substance-Related Disorders

Keywords

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Heroin abuse Opioids Opiates Substance abuse Addiction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Aprepitant

Group Type EXPERIMENTAL

aprepitant

Intervention Type DRUG

Oral, 125 mg once daily for one week

2

Placebo

Group Type PLACEBO_COMPARATOR

Pseudo-placebo - buprenorphine

Intervention Type DRUG

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

Interventions

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aprepitant

Oral, 125 mg once daily for one week

Intervention Type DRUG

Pseudo-placebo - buprenorphine

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

Intervention Type DRUG

Other Intervention Names

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Emend Subutex

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health and Social Affairs, Sweden

OTHER_GOV

Sponsor Role collaborator

County of Stockholm

UNKNOWN

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Karolinska Universitetssjukhuset

Principal Investigators

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Markus Heilig, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Universitetssjukhuset

Johan Kakko, MD

Role: STUDY_DIRECTOR

Karolinska Universitetssjukhuset

Locations

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Karolinska University Hospital, Huddinge

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Aprepitant 1

Identifier Type: -

Identifier Source: org_study_id