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

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

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.

Study Overview

• Status: Completed
• Conditions: Self Esteem
• Intervention / Treatment: Drug: Placebo; Drug: Naltrexone

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attentional bias scores for negative 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 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.	Approximately 2 hours post placebo/drug administration
Reaction times on neutral-neutral trials on visual probe task	Reaction times on neutral-neutral trials on the visual probe task were used to assess potential psychomotor side-effects of naltrexone	Approximately 2 hours post placebo/drug administration
Self-liking	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.	Approximately 2 hours post placebo/drug administration
Self-competence	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.	Approximately 2 hours post placebo/drug administration

Collaborators and Investigators

• Sponsor: McGill University
• Investigators: Principal Investigator: Jennifer Bartz, PhD, McGill University

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2012
• Primary Completion (Actual): March 15, 2013
• Study Completion (Actual): March 15, 2013

Study Registration Dates

• First Submitted: February 11, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Alcohol Deterrents; Naltrexone
• Other Study ID Numbers: A02-B12-11B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data will be made available via OSF upon publication of the paper.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No