Rebalancing the Serotonergic System in Cocaine Dependence

Cocaine Dependence Clinical Trial

Official title:

Rebalancing the Serotonergic System in Cocaine Dependence

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03266939
• Other study ID #: cocaine and serotonin
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: October 4, 2018
• Est. completion date: December 2021

Study information

• Verified date: February 2021
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Drug:
• Lorcaserin
10 mg acute administration of lorcasein
• Placebo Oral Tablet
Placebo

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influence of lorcaserin on fMRI measured brain-reactivity to drug cues.		fMRI measures will be gathered on scanning visits 1 and 2 (approx 1 week apart)