Rebalancing the Serotonergic System in Cocaine Dependence

Mass General Brigham

Status and phase: Withdrawn; Phase 1

Conditions: Cocaine Dependence

Treatments: Drug: Lorcaserin; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03266939

cocaine and serotonin

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo Oral Tablet

Active Medication

Active Comparator group

Treatment:

Drug: Lorcaserin