An fMRI Study of Opioid-related Changes in Neural Activity

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

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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