Functional Magnetic Resonance Imaging of Opioid Withdrawal in Healthy Human Volunteers

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Larry Fu-nien Chu, Stanford University
ClinicalTrials.gov Identifier:
NCT01006707
First received: October 30, 2009
Last updated: February 13, 2012
Last verified: February 2012
  Purpose

Opioid medications are commonly used for pain relief. When given over time, physical dependence can occur. This results in unpleasant side effects--such as agitation and nausea--if opioid medications are suddenly stopped. However, we do not know how withdrawal affects the brain. We know that a medication named Ondansetron can help ease or prevent symptoms associated with opioid withdrawal. Through imaging of the brain by fMRI, we hope to see how opioid withdrawal, with and without the administration of ondansetron, affects brain activity.


Condition Intervention
Substance-Related Disorders
Drug: Ondansetron

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: fMRI Imaging of Opioid Withdrawal in Healthy Human Volunteers

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • fMRI Scan [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective Opioid Withdrawal Scale [ Time Frame: 125 and 135 minutes ] [ Designated as safety issue: No ]
  • Subjective Opioid Withdrawal Scale [ Time Frame: 125 and 135 minutes ] [ Designated as safety issue: No ]
  • Cold Pressor Test [ Time Frame: 125 and 135 minutes ] [ Designated as safety issue: No ]
  • Blood Samples for Genetic Testing [ Time Frame: 125 and 135 minutes ] [ Designated as safety issue: No ]
  • Heat Pain Test [ Time Frame: 125 to 135 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: November 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ondansetron
    In this cross-over study, the blinded patient will receive saline placebo in one session and ondansetron in the other. The order is decided with a randomization table. If ondansetron is randomly chosen, an 8mg IV Bolus will be given at the start of the study for 30 minutes by the unblinded investigator.
  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Patients will be healthy male volunteers, ages 18-35.

Exclusion Criteria

  • Females were excluded due to menstrual cycle modulation of opioid response.
  • We will exclude individuals with Raynaud's disease or a history of coronary artery disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006707

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Dr Larry Fu-nien Chu Stanford University
  More Information

Publications:

Responsible Party: Larry Fu-nien Chu, Associate Professor of Anesthesia, Stanford University
ClinicalTrials.gov Identifier: NCT01006707     History of Changes
Other Study ID Numbers: SU-10212009-4200
Study First Received: October 30, 2009
Last Updated: February 13, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on September 16, 2014