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Completed

NCT Number: NCT04757506

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

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.

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Key information

Conditions

Self Esteem

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Naltrexone

Drug

opioid receptor antagonist

Placebo

Drug

Primary outcomes

  1. Self-esteem

    Time frame: 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.

  2. Attentional bias scores for positive social cues on visual probe task

    Time frame: 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 outcomes

  1. Attentional bias scores for negative social cues on visual probe task

    Time frame: 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.

  2. Reaction times on neutral-neutral trials on visual probe task

    Time frame: 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

  3. Self-liking

    Time frame: 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.

  4. Self-competence

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

McGill University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 17, 2021
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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