Neuropharmacological Basis of Social Connection: The Role of Opioids

NCT01672723 | Completed Results

• 1 other identifier: Opioids and Social Cognition
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

From birth we rely on others for comfort and care and derive pleasure from being together. Research from the fields of health psychology, social psychology, and public health converge to highlight the importance of having and maintaining good relationships for overall health. Indeed, having close friends and family and feeling connected to them has been called a basic need, similar to our need for food and water. It may not be a coincidence then that feelings of connection rely on similar systems in the body as other needs that are both basic and highly pleasing and rewarding. For instance, its possible that opioids, a substance in the body associated with pleasant, euphoric feelings, may also be important for connecting with others. This study will examine the role of opioids in feeling connected to others by administering a drug called naltrexone, that effects opioid processing in the body, on perceptions and feelings toward a number of tasks in the lab. Additionally, to assess the effects of naltrexone outside of the lab, participants will complete daily diary responses via text and online surveys. 40 participants will take both placebo and naltrexone. Participants will complete two sessions, one in each drug condition, in which they complete a number of tasks including reading messages on a computer screen, holding a number of objects, and viewing images while undergoing electric shocks. Participants will also complete a daily diary for 14 days while on naltrexone and placebo. Prior to these lab sessions participants will be screened at UCLA's Clinical \& Translational Research Center (CTRC) to ensure that they are healthy and that it is safe for them to take the study drug. We hypothesize that people will report feeling less socially connected when on naltrexone compared to placebo and will show subsequent changes in social behavior outside of the lab.

Conditions

Psychology, Social

Keywords

opioids; social connection

Outcome Measures

Primary Outcomes (1)

• Changes in Self-reported Feelings of Connection During Naltrexone (vs. Placebo)

  Participants will read positive, loving messages from friends and family members and then rate their feelings of connection (how connected, touched, and warm they felt, α = .93, averaged to create a measure of feelings of social connection). Ratings were made on a 1-7 scale anchored by "not at all" and "very." Higher numbers indicate greater feelings of connection in response to reading the loving messages.

  participants will report on their feelings of connection during two separate lab visits, on day 4 of each drug assignment

Secondary Outcomes (1)

• Daily Self-reported Feelings of Social Connection

  end of day for 8 days

Other Outcomes (1)

• Self-reported Physical Symptoms

  once a day for 8 days

Study Arms (2)

Naltrexone

EXPERIMENTAL

Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs. Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.

Drug: Naltrexone

Placebi

PLACEBO COMPARATOR

Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs. Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.

Drug: Naltrexone

Interventions

Naltrexone DRUG

Also known as: Depade, ReVia

Naltrexone; Placebi

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Following an email screening and structured telephone interview, prospective participants with the following conditions will not advance to the in- person screening session: pregnant or planning to become pregnant in the next 6 months, presence of chronic mental or physical illness, history of allergies, liver, or other severe chronic diseases, current and regular use of prescription medications, or previous history of fainting during blood draws.
• Furthermore, the absence of significant health problems or medication use history will be confirmed by an in-person screening session. Any participant who has any of the following conditions will be ineligible for the study: (1) Any and all medical conditions, especially hepatitis or liver failure.
• Psychiatric Disorders. (2) current and/or lifetime history of a major Depressive Disorder or other Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-IV) psychiatric disorder (e.g. substance dependence) (3) current and/or past regular use of analgesics such as opioids; (4) current and/or past regular use of psychotropic medications, including selective serotonergic reuptake inhibitors, antidepressants, anxiolytics, hypnotics, sedatives and barbiturates. Health factors. (5) current smokers (13) body mass index (BMI) greater than 35, (14) shows evidence of drug use from a urine test, (15) has a positive pregnancy test, if female, or (16) shows any abnormalities on screening laboratory tests.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles Department of Psychology

Los Angeles, California, 90095-1563, United States

Location

MeSH Terms

Interventions

Naltrexone

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Naomi Eisenberger
• Organization: University of California, Los Angeles

neisenbe@ucla.edu

310-267-5196

Study Officials

• Naomi I Eisenberger, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 20, 2012
• First Posted: August 27, 2012
• Study Start: October 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: January 14, 2016
• Results First Posted: January 14, 2016

Record last verified: 2015-12

Locations

US (1)