Rebalancing the Serotonergic System in Cocaine Dependence

NCT03266939 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: cocaine and serotonin
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Dependence

Outcome Measures

Primary Outcomes (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)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo Oral Tablet

Active Medication

ACTIVE COMPARATOR

Drug: Lorcaserin

Interventions

Lorcaserin DRUG

10 mg acute administration of lorcasein

Active Medication

Placebo Oral Tablet DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

lorcaserin

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Amy Janes, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 30, 2017
• Study Start: October 4, 2018
• Primary Completion: October 4, 2018
• Study Completion: October 4, 2018
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)