Self EsteemNCT04757506
An Investigation of the Effects of Opioid Receptor Blockade on Changes in Self-esteem and Social Attention
A study testing Naltrexone in people with Self Esteem, run by McGill University.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Self Esteem
- What is being tested?
- Naltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 9 Jul 2012to 15 Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- good physical health,
- normal kidney and liver function results from within previous year
Who cannot join
- allergy to naltrexone
- kidney or liver injury or disorder
- bipolar, panic, or psychotic disorders
- epilepsy
- smoking more than 15 cigarettes per day
- pregnancy
Show all 11Show fewer
- 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.
About this study
Official title: 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.
- Conditions
- Self Esteem
- Being tested
- Naltrexone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
opioid receptor antagonist
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | cellulose-filled capsule Receives: Drug: Placebo |
| Naltrexone | Experimental | single 50 mg oral dose naltrexone (capsule) Receives: Drug: Naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Approximately 2 hours post placebo/drug administration
Secondary outcomes (4)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Approximately 2 hours post placebo/drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start9 Jul 2012
- Primary completion15 Mar 2013
- Study completion15 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self EsteemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Bartz, McGill University
- Investigators
- Jennifer Bartz, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757506
- Sponsor's protocol ID
- A02-B12-11B
- Status last verified
- Feb 2021
- First submitted
- 11 Feb 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available via OSF upon publication of the paper.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Effects of Opioid Receptor Blockade on Changes in Self-esteem and Attentional Bias Toward Social Cues
- ClinicalTrials.gov ID
- NCT04757506
- Acronym / sponsor ID
- A02-B12-11B
- Conditions
- Self Esteem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 9 Jul 2012 (actual)
- Primary completion
- 15 Mar 2013 (actual)
- Study completion
- 15 Mar 2013 (actual)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebocellulose-filled capsule |
| Naltrexone | Experimental | Drug: Naltrexonesingle 50 mg oral dose naltrexone (capsule) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- good physical health,
- normal kidney and liver function results from within previous year
Key exclusion criteria (11 listed)
- allergy to naltrexone
- kidney or liver injury or disorder
- bipolar, panic, or psychotic disorders
- epilepsy
- smoking more than 15 cigarettes per day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naltrexoneopioid receptor antagonist | Drug | Naltrexone |
| Placebo | Drug | Placebo |
Primary outcome
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.
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.
4 secondary outcomes
Attentional bias scores for negative social cues on visual probe task
Time frame: Approximately 2 hours post placebo/drug administration
Reaction times on neutral-neutral trials on visual probe task
Time frame: Approximately 2 hours post placebo/drug administration
Self-liking
Time frame: Approximately 2 hours post placebo/drug administration
Self-competence
Time frame: Approximately 2 hours post placebo/drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Individual participant dataSharing planned: Yes. Data will be made available via OSF upon publication of the paper.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Bartz, PhD principal investigator
McGill University
Questions about this trial
What is this clinical trial studying?
A study testing Naltrexone in people with Self Esteem, run by McGill University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-esteem (time frame: Approximately 2 hours post placebo/drug administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.