Trial Outcomes & Findings for Opioid Modulation and Neural Reward Activation in Healthy Adults (NCT NCT04854551)

Last Updated: 2023-11-28

Results Overview

Percent signal change relative to baseline in the nucleus accumbens during cue to win $5 as assessed during functional MRI. Higher values of percent signal change indicate greater activation to reward. We will compare the active medication condition to the placebo, establishing whether there is a difference between the conditions.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

13 participants

Primary outcome timeframe

one week

Results posted on

2023-11-28

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Adults: Placebo First, Then Naltrexone This arm will receive placebo first, then active medication second Naltrexone: Naltrexone is an opioid antagonist with primary action at the mu opioid receptor. Placebo: Placebo will be used to control for expectancy effects	Healthy Adults: Active Medication First, Then Placebo This arm will receive active medication first, then placebo second Naltrexone: Naltrexone is an opioid antagonist with primary action at the mu opioid receptor. Placebo: Placebo will be used to control for expectancy effects
Overall Study STARTED	7	6
Overall Study COMPLETED	6	5
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Healthy Adults: Placebo First, Then Naltrexone This arm will receive placebo first, then active medication second Naltrexone: Naltrexone is an opioid antagonist with primary action at the mu opioid receptor. Placebo: Placebo will be used to control for expectancy effects	Healthy Adults: Active Medication First, Then Placebo This arm will receive active medication first, then placebo second Naltrexone: Naltrexone is an opioid antagonist with primary action at the mu opioid receptor. Placebo: Placebo will be used to control for expectancy effects
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Opioid Modulation and Neural Reward Activation in Healthy Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Adults: Placebo First n=6 Participants This arm will receive placebo first, then active medication second Naltrexone: Naltrexone is an opioid antagonist with primary action at the mu opioid receptor. Placebo: Placebo will be used to control for expectancy effects	Healthy Adults: Active Medication First n=5 Participants This arm will receive active medication first, then placebo second Naltrexone: Naltrexone is an opioid antagonist with primary action at the mu opioid receptor. Placebo: Placebo will be used to control for expectancy effects	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	24.8 years STANDARD_DEVIATION 4.4 • n=5 Participants	24.0 years STANDARD_DEVIATION 4.4 • n=7 Participants	24.2 years STANDARD_DEVIATION 4.6 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: one week

Population: The participants who completed the study were analyzed. They were all healthy adults who met inclusion/exclusion criteria.

Outcome measures

Outcome measures
Measure	Naltrexone n=11 Participants Participants who received Naltrexone capsules for 5 days (25mg for days 1 and 2, then 50mg for days 3, 4, and 5) before either the first or second scanning session.	Placebo n=11 Participants Participants who received Placebo capsules for 5 days before either the first or second scanning session
Change in Brain Activation to Reward Between Placebo and Active Medication	0.25 percentage signal change Standard Deviation 0.09	0.26 percentage signal change Standard Deviation 0.10

SECONDARY outcome

Timeframe: one week

Population: Healthy adults who completed the study

Maximum alcohol expenditure, or Omax, is the maximum amount of money that a person will pay for alcohol in a hypothetical alcohol consumption task called the "Alcohol Purchase Task". Higher values of Omax indicate that a person values consuming alcohol at a greater level.

Outcome measures

Outcome measures
Measure	Naltrexone n=11 Participants Participants who received Naltrexone capsules for 5 days (25mg for days 1 and 2, then 50mg for days 3, 4, and 5) before either the first or second scanning session.	Placebo n=11 Participants Participants who received Placebo capsules for 5 days before either the first or second scanning session
Alcohol Value	19.4 Dollars Standard Deviation 14.8	19.9 Dollars Standard Deviation 17.4

SECONDARY outcome

Timeframe: one week

Percent signal change from baseline in the amygdala during trials to regulate emotion relative to trials to passively experience emotion during a functional MRI scan. Cues will be negative images, and instructions will be either "decrease" or "look".

Outcome measures

Outcome measures
Measure	Naltrexone n=11 Participants Participants who received Naltrexone capsules for 5 days (25mg for days 1 and 2, then 50mg for days 3, 4, and 5) before either the first or second scanning session.	Placebo n=11 Participants Participants who received Placebo capsules for 5 days before either the first or second scanning session
Brain Activation to Emotion Regulation	0.1 percentage signal change Standard Deviation 0.1	0.1 percentage signal change Standard Deviation 0.1

Adverse Events

Naltrexone

Serious events: 0 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

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joshua Gowin

University of Colorado Anschutz Medical Campus

Phone: 3037243769

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place