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Opioid Modulation and Neural Reward Activation in Healthy Adults

NCT ID: NCT04854551

Last Updated: 2023-11-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2022-04-18

Brief Summary

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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

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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.

Conditions

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Alcohol Drinking Opioid Use, Unspecified

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants will be counterbalanced for the order they undergo placebo and medication.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
capsule, double blind

Study Groups

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Placebo, Then 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.

Group Type EXPERIMENTAL

Naltrexone

Intervention Type DRUG

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

Placebo

Intervention Type OTHER

Placebo will be used to control for expectancy effects

Naltrexone, Then 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.

Group Type EXPERIMENTAL

Naltrexone

Intervention Type DRUG

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

Placebo

Intervention Type OTHER

Placebo will be used to control for expectancy effects

Interventions

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Naltrexone

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

Intervention Type DRUG

Placebo

Placebo will be used to control for expectancy effects

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joshua Gowin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37530456 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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21-2886

Identifier Type: -

Identifier Source: org_study_id