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

K

Karolinska University Hospital

Status and phase

Unknown
Phase 1

Conditions

Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders

Treatments

Drug: Pseudo-placebo - buprenorphine
Drug: aprepitant

Study type

Interventional

Funder types

Other

Identifiers

NCT00726960
Aprepitant 1

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
Aprepitant
Treatment:
Drug: aprepitant
2
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Pseudo-placebo - buprenorphine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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