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N/A N=82 Randomized Double-blind Basic Science

An fMRI Study of Opioid-related Changes in Neural Activity

Social Acceptance

Bottom Line

View on ClinicalTrials.gov: NCT02818036 ↗
Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Bold Oxygen-level Dependent (BOLD) Activations in Prespecified ROIs — 0.117; 0.2545 BOLD signal — p=<.01

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Naltrexone (Drug); Placebo (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Tristen Inagaki
Primary completion
Jun 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Bold Oxygen-level Dependent (BOLD) Activations in Prespecified ROIs		 0.117; 0.2545 <.01 sig
PRIMARY
Self-reported Feelings of Connection in Response to the Scanner Tasks		 4.576; 4.766 .338

Summary

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

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02818036). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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