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An fMRI Study of Opioid-related Changes in Neural Activity

T

Tristen Inagaki

Status

Completed

Conditions

Social Acceptance

Treatments

Drug: Placebo
Drug: Naltrexone

Study type

Interventional

Funder types

Other

Identifiers

NCT02818036
PRO15010292

Details and patient eligibility

About

The purpose of the study is to explore the effect of blocking opioids on affiliation-related neural activity.

Enrollment

82 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • good health
  • between the ages of 18 and 35,
  • fluent in English
  • right-handed (for the fMRI scan)

Exclusion criteria

  • Self-reported current or past diagnoses of physical or mental illness.
  • Score on the Patient Health Questionnaire (depressive symptoms) above a 13
  • Positive urine drug test (for Tetrahydrocannabinol (THC), Opiates, Cocaine, Amphetamine (AMP), and Methamphetamine (mAMP))
  • Positive urine pregnancy test
  • Use of any prescription medication, except for birth control
  • Use of any over-the-counter medications on the day of the fMRI session and 24 hours after the fMRI session
  • Self-reported problems with liver functioning, including hepatitis or liver failure
  • Difficulty swallowing or taking pills
  • BMI greater than 35 or weight greater than 400 lbs
  • Claustrophobia
  • Nonremovable metal in the body

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

82 participants in 2 patient groups, including a placebo group

naltrexone
Experimental group
Description:
single 50mg dose of naltrexone
Treatment:
Drug: Naltrexone
sugar pill
Placebo Comparator group
Description:
single sugar pill
Treatment:
Drug: Placebo

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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