ClinicalTrials.gg
WithdrawnNCT03266939Updated Oct 20, 2025

Rebalancing the Serotonergic System in Cocaine Dependence

A Phase 1 interventional study of Lorcaserin and Placebo Oral Tablet in Cocaine Dependence, sponsored by Mclean Hospital. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-10-20.

Sponsored by Mclean Hospital · Phase 1, Interventional, and Basic science

Why this study was withdrawn
Study was never funded because lorcaserin was pulled from FDA approval

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Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 365 studies in Cocaine-Related Disorders with a site in United States — 7 open to participants now, 9 under way, none of them phase 3. Cocaine-Related Disorders · United States.

Enrollment
269th of 337
0 · median 37
Started
2018
with 2 others
Phase 1
86 of 365
1 open now
Registered
336th of 365
by date

Among the 365 studies in Cocaine-Related Disorders with a site in United States, this one is the 269th largest by enrollment of the 337 interventional ones that give a count, is one of 3 that started in 2018, is one of 86 in phase 1, and was the 336th registered.

Cocaine-Related Disorders

416 studies on the registry are indexed under Cocaine-Related Disorders; 12 are open to participants now.

Browse Cocaine-Related Disorders studies →

Open to participants now

7 of the 365 studies in Cocaine-Related Disorders with a site in United States are open now. Recruiting first, the newest first:

2 more — sign in →

All 7 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 11 Cocaine-Related Disorders studies recruiting now, 5 (45%) set no upper age limit and 6 (55%) stop at 75 or younger; none take children under 18; none take healthy volunteers.

This study: 18 Years to 55 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Cocaine Dependence
04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 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
  • 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

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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo Oral Tablet

  • Active comparator
    Active Medication

    Drug: Lorcaserin

Interventions

  • 10 mg acute administration of lorcasein

  • DrugPlacebo Oral Tablet

    Placebo

06

What researchers measure

Primary outcomes

  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)

07

Study locations

1 site
  • McLean Hospital
    Belmont, Massachusetts 02478, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2018 to primary completion in Oct 2018, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 23, 2017
First posted
Aug 30, 2017
StartActual
Oct 4, 2018
Primary completionActual
Oct 4, 2018
CompletionActual
Oct 4, 2018
Last update
Oct 20, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03266939
Lead sponsor
Mclean Hospital
Responsible party
Amy C. Janes (Principal Investigator, Mclean Hospital) — Principal investigator
First posted
Aug 30, 2017
Start date
Oct 4, 2018
Primary completion
Oct 4, 2018
Completion
Oct 4, 2018
Last update
Oct 20, 2025

Study contacts

Amy Janes, PhD
principal investigator · Mclean Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Lorcaserin

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