Opioid Modulation and Neural Reward Activation in Healthy Adults
- Conditions
- Opioid Use, UnspecifiedAlcohol Drinking
- Interventions
- Other: Placebo
- Registration Number
- NCT04854551
- Lead Sponsor
- University of Colorado, Denver
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
- 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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo, Then Naltrexone Placebo Participants first received placebo capsules each day in a blister pack for 5 days. After a washout period of at least 3 days, they then received naltrexone capsules (matching placebo capsules) at 25mg/day for days 1 and 2 and then 50mg/day for days 3-5 for 5 days. Naltrexone, Then Placebo Naltrexone Participants first received naltrexone capsules each day in a blister pack for 5 days. Days 1 and 2 were at 25mg/day, and days 3-5 were at 50mg/day. After a washout period of at least 3 days, they then received placebo capsules (matching naltrexone capsules) for 5 days. Naltrexone, Then Placebo Placebo Participants first received naltrexone capsules each day in a blister pack for 5 days. Days 1 and 2 were at 25mg/day, and days 3-5 were at 50mg/day. After a washout period of at least 3 days, they then received placebo capsules (matching naltrexone capsules) for 5 days. Placebo, Then Naltrexone Naltrexone Participants first received placebo capsules each day in a blister pack for 5 days. After a washout period of at least 3 days, they then received naltrexone capsules (matching placebo capsules) at 25mg/day for days 1 and 2 and then 50mg/day for days 3-5 for 5 days.
- Primary Outcome Measures
Name Time Method Change in Brain Activation to Reward Between Placebo and Active Medication one week 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.
- Secondary Outcome Measures
Name Time Method Alcohol Value one week 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 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".
Trial Locations
- Locations (1)
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States