NCT00726960

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2008

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

August 1, 2008

Status Verified

July 1, 2008

Enrollment Period

1.9 years

First QC Date

July 30, 2008

Last Update Submit

July 30, 2008

Conditions

Opioid-Related DisordersHeroin DependenceSubstance-Related Disorders

Keywords

Heroin abuseOpioidsOpiatesSubstance abuseAddiction

Outcome Measures

Primary Outcomes (1)

  • The primary outcome will be self-reported pleasurable opiate effect.

    One week

Secondary Outcomes (1)

  • The secondary outcome will be physiological opiate responses.

    One week

Study Arms (2)

1

EXPERIMENTAL

Aprepitant

Drug: aprepitant

2

PLACEBO COMPARATOR

Placebo

Drug: Pseudo-placebo - buprenorphine

Interventions

aprepitantDRUG

Oral, 125 mg once daily for one week

Also known as: Emend
1
Pseudo-placebo - buprenorphineDRUG

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

Also known as: Subutex
2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 - 50
  • Current opiate use, without dependence

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital, Huddinge

Stockholm, 14186, Sweden

Location

MeSH Terms

Conditions

Opioid-Related DisordersHeroin DependenceSubstance-Related DisordersBehavior, Addictive

Interventions

AprepitantBuprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Markus Heilig, MD, PhD

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

  • Johan Kakko, MD

    Karolinska University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 30, 2008

First Posted

August 1, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2009

Study Completion

June 1, 2010

Last Updated

August 1, 2008

Record last verified: 2008-07

Locations

SE(1)