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

Not Applicable

Completed

• Conditions: Self Esteem
• Interventions: Drug: Placebo; Drug: Naltrexone

• Registration Number: NCT04757506
• Lead Sponsor: McGill University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-09
• Primary Completion: 2013-03-15
• Study Completion: 2013-03-15
• Status Verified: 2021-02
• Study First Submitted: 2021-02-11
• Study First Submitted QC: 2021-02-15
• Last Update Submitted: 2021-02-16
• Study First Posted: 2021-02-17
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	cellulose-filled capsule
Naltrexone	Naltrexone	single 50 mg oral dose naltrexone (capsule)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.