Status:
WITHDRAWN
Rebalancing the Serotonergic System in Cocaine Dependence
Lead Sponsor:
Mclean Hospital
Conditions:
Cocaine Dependence
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
In the United States, 1.5 million people abuse cocaine leading to a host of negative health and economic consequences, yet no FDA approved treatment exists. To develop effective treatments, the follow...
Eligibility Criteria
Inclusion
- \- Participants will be male and female volunteers between the ages of 18-55
- Participants will report having used cocaine on at least four occasions within the month prior to screening; the urine sample obtained during the screening visit must be positive for the cocaine metabolite benzoylecgonine (\>300 ng/ml). They can meet DSM-IV criteria for cocaine abuse and dependence.
- Participants cannot meet DSM-IV criteria for current psychotic disorders (e.g., bipolar disorder, schizophrenia, schizoaffective disorder)
- Participants cannot meet DSM-IV criteria for a current major depressive episode
- Participants cannot meet DSM-IV criteria for current drug dependence (except nicotine, cocaine, and marihuana)
- Participants must test negative for alcohol use on the day of the scan.
- Participants can report current abuse of marihuana and tobacco. Participants cannot have used marihuana within twelve hours of their study visits.
- Participants cannot be regular opiate users including prescription opiate analgesics
- Participants cannot have a history of major head trauma resulting in cognitive impairment, seizure, or other neurological disorders.
- Participants cannot have any conditions that are contraindicated for MRI (see next section)
- Participants cannot be pregnant (pregnancy test will be performed before each scanning session)
- Participants must be able to read screening materials including consent form and give informed consent
- Participants cannot be taking any medications with a 5-HT mechanism including serotonin-norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs) and St. John's Wort and tryptophan.
- Participants cannot be currently taking any medications that might affect the central nervous system including prescription analgesics, anxiolytics, antipsychotics, and antidepressants. A complete review of medications will be evaluated by study staff.
- Cannot have any history of a medical condition that might affect the central nervous system at the time of scanning including: Abnormal structural MRI, or a history of head trauma or injury causing loss of consciousness lasting longer than 3 minutes or associated with skull fracture or intracranial bleeding or who had irremovable magnetically active objects on or within their body, or history of epilepsy.
Exclusion
- \- Weight greater than 350 pounds (cannot easily fit inside the magnet bore)
- Cardiac pacemakers
- Aneurysm clips and other vascular stents, filters, clips or other devices
- Prosthetic heart valves
- Other prostheses
- Neuro-stimulator devices
- Implanted infusion pumps
- Cochlear implants
- Ocular implants or known metal fragments in eyes
- Exposure to shrapnel or metal filings (sheet metal workers, welders, and others)
- Other metallic surgical hardware in vital areas
- History of major head trauma resulting in cognitive impairment
- Certain tattoos (e.g. older dye with metallic pigment)
- Certain medication patches (if they cannot be removed)
- Metal containing IUDs
- Claustrophobia
- Pregnancy
- Metallic implants except fillings and crowns
- Tattoos containing metallic ink on the neck, shoulders, upper arm, and head (these could become heated during scanning, potentially causing burns
- Medication patches that cannot be removed during scanning
- Claustrophobia
Key Trial Info
Start Date :
October 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03266939
Start Date
October 4 2018
End Date
October 4 2018
Last Update
October 17 2025
Active Locations (1)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478