Back to resultsOpioid Modulation and Neural Reward Activation in Healthy Adults
Primary Purpose
Alcohol Drinking, Opioid Use, Unspecified
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Naltrexone
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Alcohol Drinking
Eligibility Criteria
Inclusion Criteria:
- Between 18 and 35 years of age,
- Is a moderate drinker (i.e. consumes 1-14 drinks/week for males, or 1-7 drinks/week for females).
Exclusion Criteria:
- Non-drinker
- Positive result on urine drug screen or breathalyzer at the start of any study visit
- Inability to complete MRI (e.g. presence of ferromagnetic objects in body)
- Current use of medications that alter the hemodynamic response such as insulin
- History of trauma resulting in loss of consciousness longer than 15 minutes
- Currently taking opioid medications
- Pregnancy
Sites / Locations
- University of Colorado Anschutz Medical Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Healthy adults: placebo first
Healthy adults: active medication first
Arm Description
This arm will receive placebo first, then active medication second
This arm will receive active medication first, then placebo second
Outcomes
Primary Outcome Measures
Brain activation to reward
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.
Secondary Outcome Measures
Alcohol value
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.
Brain activation to emotion regulation
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".
Full Information
NCT ID
NCT04854551
First Posted
April 8, 2021
Last Updated
August 10, 2022
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT04854551
Brief Title
Opioid Modulation and Neural Reward Activation in Healthy Adults
Official Title
Opioid Modulation and Neural Reward Activation in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
April 18, 2022 (Actual)
Study Completion Date
April 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a double blind study of the effects of opioid antagonism on the brain's reward response. The investigators will recruit participants to undergo two scans, one on active medication and one on placebo. During the scan, the investigators will assess reward.
Detailed Description
The study will employ a crossover design. The study will use the monetary incentive delay task during functional MRI to assess reward. This task presents participants with cues indicating whether they are playing to win $5, win $0, or to avoid losing $5. This task has been well-validated to elicit activation in a key reward response area of the brain called the ventral striatum.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Opioid Use, Unspecified
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Participants will be counterbalanced for the order they undergo placebo and medication.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
capsule, double blind
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy adults: placebo first
Arm Type
Experimental
Arm Description
This arm will receive placebo first, then active medication second
Arm Title
Healthy adults: active medication first
Arm Type
Experimental
Arm Description
This arm will receive active medication first, then placebo second
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Intervention Description
Naltrexone is an opioid antagonist with primary action at the mu opioid receptor.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo will be used to control for expectancy effects
Primary Outcome Measure Information:
Title
Brain activation to reward
Description
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.
Time Frame
one week
Secondary Outcome Measure Information:
Title
Alcohol value
Description
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.
Time Frame
one week
Title
Brain activation to emotion regulation
Description
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".
Time Frame
one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Between 18 and 35 years of age,
Is a moderate drinker (i.e. consumes 1-14 drinks/week for males, or 1-7 drinks/week for females).
Exclusion Criteria:
Non-drinker
Positive result on urine drug screen or breathalyzer at the start of any study visit
Inability to complete MRI (e.g. presence of ferromagnetic objects in body)
Current use of medications that alter the hemodynamic response such as insulin
History of trauma resulting in loss of consciousness longer than 15 minutes
Currently taking opioid medications
Pregnancy
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The investigators would either upload to an online repository or share directly with individuals wishing to access it.
Learn more about this trial
Opioid Modulation and Neural Reward Activation in Healthy Adults
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