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

Self Esteem Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04757506
• Other study ID #: A02-B12-11B
• Status: Completed
• Phase: N/A
• Start date: July 9, 2012
• Est. completion date: March 15, 2013

Study information

• Verified date: February 2021
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 15, 2013
• Est. primary completion date: March 15, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Self Esteem

Intervention

Drug:
• Naltrexone
opioid receptor antagonist
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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