Lorcaserin for Cannabis Use Disorder

Stopped early · Early Phase 1 · Has a placebo group

Conditions studied: Cannabis Use Disorder

In brief

The primary purpose of this study is to investigate the effect of lorcaserin on reductions in cannabis use and multiple constructs of impulsivity in outpatient treatment-seeking individuals with cannabis use disorder (CUD). Additionally, the investigators will make use of the technological application of ecological momentary assessments (EMA), to collect real-time data at key time intervals during the study on participants' use of cannabis and other substances in addition to measuring impulsive traits through self-initiated, fixed and random phone prompts. This will be a 13-week randomized, double-blind, placebo-controlled trial, with week 1 focused on baseline assessments of impulsivity (through EMA in vivo and at study visits), weeks 2- 3 of medication lead-in, and week 4 targeting a reduced cannabis use/quit day through week 13. The primary aims are to (1) Examine the effect of lorcaserin compared to placebo, on reductions in cannabis use among treatment-seeking outpatients with CUD, (2) Examine the effect of lorcaserin compared to placebo on behavioral and self-report measures of impulsivity among individuals with CUD during the medication lead-in phase (weeks 2-3). The secondary aim is to examine whether reductions in impulsivity (during weeks 2-3) mediates the effect of lorcaserin on cannabis use (during weeks 8-13), if the primary hypotheses are supported. Finally, the investigators will explore the effect of lorcaserin compared to placebo on (1) drop-out rates, (2) time to discontinuation from study, (3) treatment adherence, and (4) nicotine use.

Key facts

Study ID: NCT03637842
Run by: New York State Psychiatric Institute
People needed: 5
Starts: 2019-08-01
Expected to finish: 2020-02-29
Last updated by the study team: 2021-01-28

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Individuals between the ages of 18-70
Meets DSM-V criteria for a current cannabis use disorder
Seeking treatment for cannabis use disorder
THC-positive urine drug screen
Capable of giving informed consent and complying with study procedures
Has regular access to the internet by any means
Not underweight (Defined as BMI ≥18.5)

You may not qualify if…

Lifetime history of DSM-V diagnosis of schizophrenia or schizoaffective disorder
Current DSM-V criteria for a psychiatric disorder supported by the MINI that in the investigator's judgment is unstable, would be disrupted by the study medication, or is likely to require new pharmacotherapy or psychotherapy during the study period. Individuals who are currently stable on psychotropic medication for at least 3months may be included if in the investigator's opinion the psychotropic medication is compatible with the study medication (lorcaserin).
Individuals who meet DSM-V criteria for any moderate to severe substance use disorder other an cannabis, caffeine or nicotine use disorders
Pregnancy, lactation, or failure to use adequate contraceptive method in female patients who are currently engaging in sexual activity with men
Unstable medical conditions, such as AIDS, cancer, uncontrolled hypertension, uncontrolled diabetes, pulmonary hypertension or heart disease; or individuals with a history of serotonin syndrome
Legally mandated to participate in a substance use disorder treatment program
Current or recent history of significant violent or suicidal behavior, risk for suicide or homicide
Currently meets DSM-V diagnosis for an eating disorder or is underweight (BMI <18.5)
Elevated liver function tests (AST and ALT > 3 times the upper limit of normal) or impaired renal function
Known history of allergy, intolerance, or hypersensitivity to lorcaserin
Concurrent use of migraine medications ergotamine (Cafergot, Ergomar) or dihydroergotamine (Migranal), 5HT2B receptor agonists like cabergoline, medications metabolized by CYP2D6 (thioridazine, tamoxifen, metoprolol, aripiprazole, codeine,, MAOIs, or St. John's Wort

Where it is running

Columbia Substance Treatment and Research Service — New York, New York, United States

Full record on ClinicalTrials.gov

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