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

Sponsor

McGill University (Other)

Overall Status

Completed

CT.gov ID

NCT04757506

Collaborator

(none)

Enrollment

Arms

8.2

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Self Esteem	Drug: Naltrexone Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

An Investigation of the Effects of Opioid Receptor Blockade on Changes in Self-esteem and Attentional Bias Toward Social Cues

Actual Study Start Date :

Jul 9, 2012

Actual Primary Completion Date :

Mar 15, 2013

Actual Study Completion Date :

Mar 15, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo cellulose-filled capsule	Drug: Placebo
Experimental: Naltrexone single 50 mg oral dose naltrexone (capsule)	Drug: Naltrexone opioid receptor antagonist

Arm

Intervention/Treatment

Placebo Comparator: Placebo

cellulose-filled capsule

Drug: Placebo

Experimental: Naltrexone

single 50 mg oral dose naltrexone (capsule)

Drug: Naltrexone

opioid receptor antagonist

Outcome Measures

Primary Outcome Measures

Self-esteem [Approximately 2 hours post placebo/drug administration]
Self-reported levels of self-esteem assessed using the Rosenberg Self-Esteem Scale (Rosenberg, 1965). Possible scores range from 1 to 4. Higher scores indicate higher levels of self-esteem.
Attentional bias scores for positive social cues on visual probe task [Approximately 2 hours post placebo/drug administration]
Attentional bias was assessed using a Visual Probe Task. The investigators used a version of the VPT (DeWall, Maner, & Rouby, 2009) designed to assess attentional bias to cues of social acceptance (i.e., smiles). The outcome measure was attentional bias scores, calculated by subtracting mean reaction time scores on "valid" trials from mean reaction time on "invalid" trials. Higher positive scores indicate greater attentional bias to accepting faces.

Secondary Outcome Measures

Attentional bias scores for negative social cues on visual probe task [Approximately 2 hours post placebo/drug administration]
Attentional bias was assessed using a Visual Probe Task. The investigators used a version of the VPT (DeWall, Maner, & Rouby, 2009) designed to assess attentional bias to cues of social rejection (i.e., disapproving faces). The outcome measure was attentional bias scores, calculated by subtracting mean reaction time scores on "valid" trials from mean reaction time on "invalid" trials. Higher positive scores indicate greater attentional bias to disapproving faces.
Reaction times on neutral-neutral trials on visual probe task [Approximately 2 hours post placebo/drug administration]
Reaction times on neutral-neutral trials on the visual probe task were used to assess potential psychomotor side-effects of naltrexone
Self-liking [Approximately 2 hours post placebo/drug administration]
For exploratory purposes, the self-esteem measure (Rosenberg, 1965) was split into two separate subscales examining feelings of self-liking and self-competence as in Tafarodi & Milne, 2002. Self-liking is thought to be more relationally derived and based on internalized perceptions of social approval. Scores range from 1 to 4, with higher scores indicating higher levels of self-liking.
Self-competence [Approximately 2 hours post placebo/drug administration]
For exploratory purposes, the self-esteem measure (Rosenberg, 1965) was split into two separate subscales examining feelings of self-liking and self-competence as in Tafarodi & Milne, 2002. Self-competence is thought to be more autonomously derived and based on past goal pursuit. Scores range from 1 to 4, with higher scores indicating higher levels of self-competence.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

McGill University

Investigators

Principal Investigator: Jennifer Bartz, PhD, McGill University

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Feb 11, 2021

More Information

Publications

None provided.

Responsible Party:

Jennifer Bartz, Professor, McGill University

ClinicalTrials.gov Identifier:

NCT04757506

Other Study ID Numbers:

A02-B12-11B

First Posted:

Feb 17, 2021

Last Update Posted:

Feb 18, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Naltrexone

Study Results

No Results Posted as of Feb 18, 2021