Rebalancing the Serotonergic System in Cocaine Dependence

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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 following must be considered: 1) do potential medications ameliorate brain disruptions associated with cocaine use? 2) are multiple, targeted treatments necessary? To meet these goals, innovative multi-modal neuroimaging will be used to determine whether rebalancing the serotonergic (5-HT) system reduces cocaine cue reactivity, impulsivity, and normalizes related neurochemistry and brain connectivity.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mclean Hospital
• Treatments: Cocaine

Criteria

Inclusion Criteria:

• - 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 Criteria:

• - 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