Rebalancing the Serotonergic System in Cocaine Dependence (NCT03266939) | Clinical Trial Compass
WithdrawnPhase 1
Rebalancing the Serotonergic System in Cocaine Dependence
Stopped: Study was never funded because lorcaserin was pulled from FDA approval
United States0Started 2018-10-04
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 cann…
What they're measuring
1
Influence of lorcaserin on fMRI measured brain-reactivity to drug cues.
Timeframe: fMRI measures will be gathered on scanning visits 1 and 2 (approx 1 week apart)