Functional Magnetic Resonance Imaging of Opioid Withdrawal in Healthy Human Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 35 |
| Updated: | 11/19/2017 |
| Start Date: | November 2010 |
| End Date: | July 2013 |
fMRI Imaging of Opioid Withdrawal in Healthy Human Volunteers
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.
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.
During the study, each participant attended three separate lab-based acute opioid withdrawal
sessions. The first session was undertaken in a mock MRI scanner and was designed to
determine if participants could tolerate withdrawal in the scanning environment. Participants
who were able to successfully and safely tolerate opioid withdrawal while in the scanner were
approved to continue with the following study sessions. Participants were then pretreated
intravenously (IV) with either 0.9% normal saline placebo or 8mg ondansetron. Later,
participants in all sessions received IV naloxone (10mg/70kg) to precipitate opioid
withdrawal. Participants were assigned to ondansetron or placebo pretreatment conditions in a
randomized, double-blinded, and counter-balanced order. Objective Opioid Withdrawal Scale
(OOWS) and Subjective Opioid Withdrawal Scale (SOWS) were assessed throughout the study to
quantify withdrawal. Study timeline progressed as follows: T=-165, 8mg ondansetron or placebo
infusion, T=-135, Morphine infusion (10mg/70kg), T=-41 preparation for MRI, T=-21, start MRI,
T=-13, baseline OOWS/SOWS, T=-9, start of fMRI, T=0 Naloxone induced withdrawal, T=5, OOWS,
T=15, OOWS, T=20, Retrospective OOWS.
sessions. The first session was undertaken in a mock MRI scanner and was designed to
determine if participants could tolerate withdrawal in the scanning environment. Participants
who were able to successfully and safely tolerate opioid withdrawal while in the scanner were
approved to continue with the following study sessions. Participants were then pretreated
intravenously (IV) with either 0.9% normal saline placebo or 8mg ondansetron. Later,
participants in all sessions received IV naloxone (10mg/70kg) to precipitate opioid
withdrawal. Participants were assigned to ondansetron or placebo pretreatment conditions in a
randomized, double-blinded, and counter-balanced order. Objective Opioid Withdrawal Scale
(OOWS) and Subjective Opioid Withdrawal Scale (SOWS) were assessed throughout the study to
quantify withdrawal. Study timeline progressed as follows: T=-165, 8mg ondansetron or placebo
infusion, T=-135, Morphine infusion (10mg/70kg), T=-41 preparation for MRI, T=-21, start MRI,
T=-13, baseline OOWS/SOWS, T=-9, start of fMRI, T=0 Naloxone induced withdrawal, T=5, OOWS,
T=15, OOWS, T=20, Retrospective OOWS.
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.
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