Rebalancing the Serotonergic System in Cocaine Dependence
Primary Purpose
Cocaine Dependence
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lorcaserin
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional basic science trial for Cocaine Dependence
Eligibility Criteria
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
Sites / Locations
- McLean Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Active Medication
Arm Description
Outcomes
Primary Outcome Measures
Influence of lorcaserin on fMRI measured brain-reactivity to drug cues.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03266939
Brief Title
Rebalancing the Serotonergic System in Cocaine Dependence
Official Title
Rebalancing the Serotonergic System in Cocaine Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 4, 2018 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Active Medication
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lorcaserin
Intervention Description
10 mg acute administration of lorcasein
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Janes, PhD
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Rebalancing the Serotonergic System in Cocaine Dependence
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