Rebalancing the Serotonergic System in Cocaine Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03266939
Recruitment Status : Not yet recruiting
First Posted : August 30, 2017
Last Update Posted : March 22, 2018
Information provided by (Responsible Party):
Amy C. Janes, Mclean Hospital

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 Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo Oral Tablet

Active Comparator: Active Medication Drug: Lorcaserin
10 mg acute administration of lorcasein

Primary Outcome Measures :
  1. Influence of lorcaserin on fMRI measured brain-reactivity to drug cues. [ Time Frame: fMRI measures will be gathered on scanning visits 1 and 2 (approx 1 week apart) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
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 can report current dependence of alcohol
  • Participants can report current abuse of marihuana, tobacco and alcohol but must test negative for alcohol on the day of the scan. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03266939

Contact: Amy Janes, PhD (617)855-3244
Contact: Maya Zegel, BA (617) 855-3682

Sponsors and Collaborators
Mclean Hospital

Responsible Party: Amy C. Janes, Principal Investigator, Mclean Hospital Identifier: NCT03266939     History of Changes
Other Study ID Numbers: cocaine and serotonin
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
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
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents