Neuropharmacological Basis of Social Connection: The Role of Opioids

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Naomi Eisenberger, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01672723
First received: August 20, 2012
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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 & Tranlational 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.


Condition Intervention
Psychology, Social
Drug: Naltrexone

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Neuropharmacological Basis of Social Connection: The Role of Opioids

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • self-reported feelings of connection [ Time Frame: participants will report on their feelings of connection during two separate lab visits, once during each drug assignment, approximately 2 weeks apart ] [ Designated as safety issue: No ]
    Participants will read positive, loving messages from friends and family members and will then respond to the question "How connected did reading the messages make you feel?"


Secondary Outcome Measures:
  • daily self-reported feelings of social connection [ Time Frame: 9 times a day for 14 days ] [ Designated as safety issue: No ]
    Participants will respond to daily text messages about their feelings of connection when on naltrexone and when on placebo.


Other Outcome Measures:
  • self-reported physical symptoms [ Time Frame: once a day for 14 days ] [ Designated as safety issue: Yes ]
    At the end of each day while on a study drug (7 days during naltrexone and 7 days during placebo) participants will report on their physical symptoms.


Enrollment: 31
Study Start Date: October 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Naltrexone

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
Other Names:
  • Depade
  • ReVia

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inclusion criteria for the study require that participants be in good health, between the ages of 18 and 35, fluent in English, have access to text messaging technology, and have at least 8 close friends and family members who would be willing to be contacted in regards to the study (for the social connection lab task) and be willing to provide 2 pictures of a close other (for the threat of shock task).

Exclusion Criteria:

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 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 serotinergic 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01672723

Locations
United States, California
UCLA Department of Psychology
Los Angeles, California, United States, 90095-1563
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Naomi I Eisenberger, PhD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Naomi Eisenberger, Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01672723     History of Changes
Other Study ID Numbers: Opioids and Social Cognition
Study First Received: August 20, 2012
Last Updated: February 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:
opioids
social connection

Additional relevant MeSH terms:
Naltrexone
Analgesics, Opioid
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 17, 2014