Cocaine cure study pulled before it even started
NCT ID NCT03266939
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study was designed to test whether a drug called lorcaserin could help people with cocaine dependence by rebalancing serotonin in the brain. Researchers planned to use brain scans to see if the drug reduced cravings and impulsivity. However, the study was withdrawn before enrolling any participants, so no results are available.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Started
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Oct 2018
- Finished
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Oct 2018
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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McLean Hospital
Belmont, Massachusetts, 02478, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.