Rebalancing the Serotonergic System in Cocaine Dependence

• Sponsor: Mclean Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03266939
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 37.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Cocaine Dependence	Drug: Lorcaserin; Drug: Placebo Oral Tablet	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Rebalancing the Serotonergic System in Cocaine Dependence
• Actual Study Start Date: Oct 4, 2018
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Placebo Oral Tablet; Placebo
Active Comparator: Active Medication	Drug: Lorcaserin; 10 mg acute administration of lorcasein

Outcome Measures

Primary Outcome Measures

1. 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)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McLean Hospital	Belmont	Massachusetts	United States	02478

Sponsors and Collaborators

• Mclean Hospital

Investigators

• Principal Investigator: Amy Janes, PhD, Mclean Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amy C. Janes, Principal Investigator, Mclean Hospital
• ClinicalTrials.gov Identifier: NCT03266939
• Other Study ID Numbers: cocaine and serotonin
• First Posted: Aug 30, 2017
• Last Update Posted: Feb 23, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Cocaine-Related Disorders

Study Results

No Results Posted as of Feb 23, 2021