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Lorcaserin for Cannabis Use Disorder

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ClinicalTrials.gov Identifier: NCT03637842
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : October 11, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Christina Ann Brezing, New York State Psychiatric Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cannabis Use Disorder Drug: Lorcaserin Drug: Placebo oral capsule Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double Blind Randomized Controlled Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Encapsulated medication
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Lorcaserin for Cannabis Use Disorder
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : July 30, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
Drug Information available for: Lorcaserin

Arm Intervention/treatment
Active Comparator: Lorcaserin XR
Lorcaserin XR 20mg daily
Drug: Lorcaserin
Lorcaserin XR 20mg per day
Other Name: Belviq

Placebo Comparator: Placebo
Placebo Oral Capsule
Drug: Placebo oral capsule
Placebo




Primary Outcome Measures :
  1. Self-report of cannabis use (episodes per day through ecological momentary assessment) [ Time Frame: 13 weeks of study or participants length of participation ]
    average weekly mean episodes of cannabis use per day based on self report as collected by the Time Line Follow back


Secondary Outcome Measures :
  1. Timeline Follow Back; days of abstinence from cannabis [ Time Frame: 13 weeks of study or participants length of participation ]
    Number of days of abstinence per week based on self report as collected by the Time Line Follow back

  2. Urine toxicology [ Time Frame: 13 weeks of study or participants length of participation ]
    Weekly THC-COOH urine levels

  3. 5 Choice Reaction Time Task [ Time Frame: week 4 and 13 weeks ]
    Number of premature responses (higher number premature responses, the greater the impulsivity)


Other Outcome Measures:
  1. Treatment completion [ Time Frame: 13 weeks ]
    Drop-out rates



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Lifetime history of DSM-V diagnosis of schizophrenia or schizoaffective disorder
  2. 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).
  3. Individuals who meet DSM-V criteria for any moderate to severe substance use disorder other an cannabis, caffeine or nicotine use disorders
  4. Pregnancy, lactation, or failure to use adequate contraceptive method in female patients who are currently engaging in sexual activity with men
  5. Unstable medical conditions, such as AIDS, cancer, uncontrolled hypertension, uncontrolled diabetes, pulmonary hypertension or heart disease; or individuals with a history of serotonin syndrome
  6. Legally mandated to participate in a substance use disorder treatment program
  7. Current or recent history of significant violent or suicidal behavior, risk for suicide or homicide
  8. Currently meets DSM-V diagnosis for an eating disorder or is underweight (BMI <18.5)
  9. Elevated liver function tests (AST and ALT > 3 times the upper limit of normal) or impaired renal function
  10. Known history of allergy, intolerance, or hypersensitivity to lorcaserin
  11. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03637842


Contacts
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Contact: Christina Brezing, MD 6467748181 christina.brezing@nypsi.columbia.edu

Locations
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United States, New York
Columbia Substance Treatment and Research Service Recruiting
New York, New York, United States, 10019
Contact: Christina A Brezing, MD    646-774-6132    christina.brezing@nyspi.columbia.edu   
Contact: R         
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Christina Brezing, MD CUMC/NYSPI

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Responsible Party: Christina Ann Brezing, Clinical Psychiatrist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03637842     History of Changes
Other Study ID Numbers: 7662
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christina Ann Brezing, New York State Psychiatric Institute:
cannabis
impulsivity
Additional relevant MeSH terms:
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Disease
Marijuana Abuse
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders