Opioid Modulation and Neural Reward Activation in Healthy Adults

NCT04854551 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 21-2886
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking; Opioid Use, Unspecified

Outcome Measures

Primary Outcomes (1)

• Change in Brain Activation to Reward Between Placebo and Active Medication

  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.

  one week

Secondary Outcomes (2)

• Alcohol Value

  one week

• Brain Activation to Emotion Regulation

  one week

Study Arms (2)

Placebo, Then Naltrexone

EXPERIMENTAL

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.

Drug: Naltrexone; Other: Placebo

Naltrexone, Then Placebo

EXPERIMENTAL

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.

Drug: Naltrexone; Other: Placebo

Interventions

Naltrexone DRUG

Naltrexone is an opioid antagonist with primary action at the mu opioid receptor.

Naltrexone, Then Placebo; Placebo, Then Naltrexone

Placebo OTHER

Placebo will be used to control for expectancy effects

Naltrexone, Then Placebo; Placebo, Then Naltrexone

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Gowin JL, Sloan ME, Kirk-Provencher KT, Rosenblatt SL, Penner AE, Stangl BL, Byrd ND, Swan JE, Ramchandani VA. Opioid receptor antagonism and neural response to monetary rewards: Pilot studies in light and heavy alcohol users. J Psychopharmacol. 2023 Sep;37(9):937-941. doi: 10.1177/02698811231191707. Epub 2023 Aug 2.

  PMID: 37530456 DERIVED

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Joshua Gowin
• Organization: University of Colorado Anschutz Medical Campus

joshua.gowin@cuanschutz.edu

3037243769

Study Officials

• Joshua Gowin, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: capsule, double blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be counterbalanced for the order they undergo placebo and medication.

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 22, 2021
• Study Start: May 1, 2021
• Primary Completion: April 18, 2022
• Study Completion: April 18, 2022
• Last Updated: November 28, 2023
• Results First Posted: November 28, 2023

Record last verified: 2023-11

Locations

US (1)