Trial Outcomes & Findings for Neuropharmacological Basis of Social Connection: The Role of Opioids (NCT NCT01672723)

Last Updated: 2016-01-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

34 participants

Primary outcome timeframe

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

Results posted on

2016-01-14

Participant Flow

Participants were recruited from the UCLA community and surrounding areas and were run between December 2012 and February 2014.

50 screened, 19 excluded (1 asked to be removed, 15 did not respond to additional scheduling requests or additional requests for information for the lab task, 3 reported stomach discomfort at a severe level and were removed).

Participant milestones

Participant milestones
Measure	Naltrexone First, Then Placebo Participants took 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) followed by a 10-day washout period and finally, 4 matched placebo pills for another 4 days.	Placebo First, Then Naltrexone Participants took 4 placebo pills over 4 days (one pill a day), followed by a 10-day washout period, followed by 4 naltrexone pills for 4 days (25 mg on days 1 and 2, 50mg on days 3 and 4)
First Intervention STARTED	19	15
First Intervention COMPLETED	16	15
First Intervention NOT COMPLETED	3	0
Washout Period of 10 Days STARTED	16	15
Washout Period of 10 Days COMPLETED	16	15
Washout Period of 10 Days NOT COMPLETED	0	0
Second Intervention STARTED	16	15
Second Intervention COMPLETED	16	15
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Naltrexone First, Then Placebo Participants took 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) followed by a 10-day washout period and finally, 4 matched placebo pills for another 4 days.	Placebo First, Then Naltrexone Participants took 4 placebo pills over 4 days (one pill a day), followed by a 10-day washout period, followed by 4 naltrexone pills for 4 days (25 mg on days 1 and 2, 50mg on days 3 and 4)
First Intervention Adverse Event	3	0

Baseline Characteristics

Neuropharmacological Basis of Social Connection: The Role of Opioids

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Naltrexone First and Placebo First n=31 Participants Includes groups randomized to receive naltrexone first and placebo first.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	21.55 years STANDARD_DEVIATION 3.34 • n=93 Participants
Sex: Female, Male Female	21 Participants n=93 Participants
Sex: Female, Male Male	10 Participants n=93 Participants
Region of Enrollment United States	31 participants n=93 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Naltrexone n=31 Participants 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. Naltrexone	Placebo n=31 Participants 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.
Changes in Self-reported Feelings of Connection During Naltrexone (vs. Placebo)	5.92 units on a scale Standard Error .189	6.47 units on a scale Standard Error .183

SECONDARY outcome

Timeframe: end of day for 8 days

For 8 days (4 while on placebo, 4 while on naltrexone), participants were asked to think back to the last 24 hours and respond to how disconnected they felt ("I felt out of touch and disconnected from others"). Ratings were made on a 1-7 scale anchored by 'strongly disagree' and 'strongly agree.' For ease of interpretation, feelings of disconnection were reverse-coded to measure daily feelings of social connection. Thus higher numbers indicate greater feelings of connection. Responses were averaged across the 4 days that participants were on each study drug (4 while on placebo, 4 while on naltrexone).

Outcome measures

Outcome measures
Measure	Naltrexone n=31 Participants 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. Naltrexone	Placebo n=31 Participants 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.
Daily Self-reported Feelings of Social Connection	5.68 units on a scale Standard Error 0.29	6.26 units on a scale Standard Error 0.22

OTHER_PRE_SPECIFIED outcome

Timeframe: once a day for 8 days

At the end of each day while on a study drug (4 days when on naltrexone and 4 days when on placebo) participants reported on their physical symptoms (headaches, dizziness/faintness, nausea, appetite increase/decrease) on a 0 (no symptoms) to 4 (very severe) scale. Responses were averaged across study drug to evaluate a single outcome for days when participants were on naltrexone and a single outcome for days when participants were on placebo.

Outcome measures

Outcome measures
Measure	Naltrexone n=31 Participants 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. Naltrexone	Placebo n=31 Participants 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.
Self-reported Physical Symptoms	.391 units on a scale Standard Deviation .039	.101 units on a scale Standard Deviation .070

Adverse Events

Naltrexone

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Naltrexone n=34 participants at risk 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.	Placebo n=34 participants at risk 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.
Gastrointestinal disorders stomach discomfort	8.8% 3/34 • Number of events 3 • naltrexone administered once daily for 4 days (25mg for days 1 and 2, 50mg for days 3 and 4) placebo administered once daily for 4 days	0.00% 0/34 • naltrexone administered once daily for 4 days (25mg for days 1 and 2, 50mg for days 3 and 4) placebo administered once daily for 4 days

Other adverse events

Adverse event data not reported

Additional Information

Dr. Naomi Eisenberger

University of California, Los Angeles

Phone: 310-267-5196

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place