Phase 2
N=13
Opioid Modulation and Neural Reward Activation in Healthy Adults
Alcohol Drinking · Opioid Use, Unspecified
Bottom Line
View on ClinicalTrials.gov: NCT04854551 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Change in Brain Activation to Reward Between Placebo and Active Medication — 0.25; 0.26 percentage signal change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Naltrexone (Drug); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Brain Activation to Reward Between Placebo and Active Medication |
0.25; 0.26 | — |
| SECONDARY Alcohol Value |
19.4; 19.9 | — |
| SECONDARY Brain Activation to Emotion Regulation |
0.1; 0.1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04854551). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.