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

NCT04757506 | Completed

• 1 other identifier: A02-B12-11B
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Self Esteem

Outcome Measures

Primary Outcomes (2)

• Self-esteem

  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.

  Approximately 2 hours post placebo/drug administration

• Attentional bias scores for positive social cues on visual probe task

  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.

  Approximately 2 hours post placebo/drug administration

Secondary Outcomes (4)

• Attentional bias scores for negative social cues on visual probe task

  Approximately 2 hours post placebo/drug administration

• Reaction times on neutral-neutral trials on visual probe task

  Approximately 2 hours post placebo/drug administration

• Self-liking

  Approximately 2 hours post placebo/drug administration

• Self-competence

  Approximately 2 hours post placebo/drug administration

Study Arms (2)

Placebo

PLACEBO COMPARATOR

cellulose-filled capsule

Drug: Placebo

Naltrexone

EXPERIMENTAL

single 50 mg oral dose naltrexone (capsule)

Drug: Naltrexone

Interventions

Naltrexone DRUG

opioid receptor antagonist

Naltrexone

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University: lead

MeSH Terms

Interventions

Naltrexone

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Jennifer Bartz, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 17, 2021
• Study Start: July 9, 2012
• Primary Completion: March 15, 2013
• Study Completion: March 15, 2013
• Last Updated: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP