Rebalancing the Serotonergic System in Cocaine Dependence

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cocaine Dependence
• Intervention / Treatment: Drug: Placebo Oral Tablet; Drug: Lorcaserin

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • McLean Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Mclean Hospital
• Investigators: Principal Investigator: Amy Janes, PhD, McLean Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2018
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 30, 2017

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Cocaine-Related Disorders
• Other Study ID Numbers: cocaine and serotonin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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