Impact of Naloxone on the Analgesic Effect of Paracetamol in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00750048

Enrollment

Registered

2008-09-10

Start date

2008-09-30

Completion date

2008-11-30

Last updated

2012-01-30

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

Conditions

Pain

Keywords

pain,, sensitization,, analgesia

Brief summary

The aim of this study is to check if Naloxone induce an inhibiting effect on the analgesic effect of paracetamol in healthy volunteer, using evoked potentials.

Detailed description

Double Blind, cross-over study in healthy volunteers.

Interventions

DRUGNaloxone and paracetamol

to check if naloxone induce an inhibiting effect on the analgesic effect of paracetamol in healthy volunteer, using evoked potentials

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy men * between 18 and 40 years old * written consent given

Exclusion criteria

* Naloxone or paracetamol hypersensibility * Excessive consumption of alcohol, tobacco, coffee, tea or toxicomania * Concomitant medication

Design outcomes

Primary

Measure	Time frame
Variation of amplitude of the N2P2 cerebral wave (before and after administration of Naloxone) induced by thermal stimulus applied on the arm.	before and after administration of Naloxone

Secondary

Measure	Time frame
Follow up of pain's evaluation using analogical visual scale. Follow up of pain's evaluation using analogical visual scale	following the pain's evaluation

Countries

France

Outcome results

None listed

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