An Investigation of the Effects of Opioid Receptor Blockade on Changes in Self-esteem and Social Attention

NCT ID: NCT04757506

Last Updated: 2021-02-18

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

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-09

Study Completion Date

2013-03-15

Brief Summary

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The purpose of this study is to explore the effects of endogenous opioids on self-esteem and attentional bias toward social cues. This is achieved by administering the drug naltrexone, which temporarily decreases endogenous opioid activity.

Detailed Description

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Conditions

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Self Esteem

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

cellulose-filled capsule

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Naltrexone

single 50 mg oral dose naltrexone (capsule)

Group Type EXPERIMENTAL

Naltrexone

Intervention Type DRUG

opioid receptor antagonist

Interventions

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Naltrexone

opioid receptor antagonist

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* good physical health,
* normal kidney and liver function results from within previous year

Exclusion Criteria

* allergy to naltrexone
* kidney or liver injury or disorder
* bipolar, panic, or psychotic disorders
* epilepsy
* smoking more than 15 cigarettes per day
* pregnancy
* substance abuse
* use of opioid analgesics, cocaine, recreational drugs (e.g., marijuana, LSD, ecstasy, etc.), or prescription medication (except oral contraceptives) within the past 10 days
* use of over-the-counter drugs (e.g., analgesics, anti-inflammatories, sleeping aids, etc.) or alcohol within the past 24 hours
* current experience of pain (e.g., headache)
* use of anti-diarrheal medications in the 7 days prior to the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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McGill University

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Bartz

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Bartz, PhD

Role: PRINCIPAL_INVESTIGATOR

McGill University

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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A02-B12-11B

Identifier Type: -

Identifier Source: org_study_id

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