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Lorcaserin for Cannabis Use Disorder

Primary Purpose

Cannabis Use Disorder

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lorcaserin
Placebo oral capsule
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Use Disorder focused on measuring cannabis, impulsivity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia Substance Treatment and Research Service

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lorcaserin XR

Placebo

Arm Description

Lorcaserin XR 20mg daily

Placebo Oral Capsule

Outcomes

Primary Outcome Measures

Number of Participants Who Achieved a Reduction in Cannabis Use Per Daily Quartiles
descriptive of cannabis use per day captured in daily quartiles based on self report as collected by the Time Line Follow back. The quartiles defined as follows: 12AM-6AM; 6AM-12PM; 12PM-6PM;6PM-12AM. Participants would report if they used during each of these times.

Secondary Outcome Measures

Full Information

First Posted
July 19, 2018
Last Updated
January 12, 2021
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03637842
Brief Title
Lorcaserin for Cannabis Use Disorder
Official Title
Randomized Controlled Trial of Lorcaserin for Cannabis Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
terminated due to lorcaserin recall
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
February 29, 2020 (Actual)
Study Completion Date
February 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Cannabis use disorder (CUD) is a major public health problem associated with significant psychiatric and medical morbidity, poor performance, and legal consequences.4 4.2 million people in the United States meet criteria for CUD.5 15% of all admissions for substance abuse treatment were related to cannabis as the primary, presenting problem in 2014 and 86% of those admissions were referred for ambulatory care.6 Despite the large number of patients with CUD seeking outpatient treatment, the investigators have limited options available. While evidence-based practices (EBP), and specifically psychotherapies, have been studied to treat CUD and various approaches have been shown to have clinical utility,7-9 many patients have difficulty achieving significant reductions in their use or sustained abstinence.10 This is further complicated by patients' limited access to EBPs,11 frequent poor adherence by therapists in the community to EBP interventions,12-14 and challenges in treating CUD with EBPs when available in community settings.10 Finding effective medications for the treatment of CUD is essential. There are no FDA approved medications for CUD. A number of pharmacological treatment trials for CUD have been performed.1* While some agents have shown promise,15-17 no medication strategy has emerged as clearly efficacious in producing abstinence.1,18 As the changing legal landscape influences patients' goals for reductions in cannabis use as compared to abstinence only, and with increasing support from the research community, future studies need to identify medications that lead to reductions in cannabis use. Impulsivity has been linked to the predisposition,19 severity,20 and poor treatment outcomes21, 22 in cannabis users and CUD, making it a prime pharmacology target. Notably, there is an entwined relationship between cannabis and impulsivity. Impulsivity as a neurobehavioral trait is associated with cannabis use,and acute and chronic use of cannabis has been shown to exacerbate impulsivity, with some mixed evidence likely attributable to diverse constructs of impulsivity used across studies. While the investigators may not be able to fully determine which came first-the impulsivity or the cannabis use, further research is needed to demonstrate whether reductions across constructs of impulsivity can lead to improvements in CUD, and vice versa. Over the last two decades, 5HT2C receptor agonists have been shown to alter neurobiological systems of addiction and relevant drug use behavior in the preclinical literature by increasing inhibitory control on mesolimibic dopamine processes and resultant incentive motivation based behaviors,23 both directly and indirectly, particularly with regards to their impact on reducing impulsivity.24 In 2012, lorcaserin, a selective 5HT2C receptor agonist, was approved by the FDA, allowing for clinical exploration of its role in the treatment of substance use disorders, including CUD.25 Recently, a fully powered clinical trial of lorcaserin for tobacco smoking cessation was positive.26 The primary purpose of this study is therefore to investigate the effect of lorcaserin on reductions in cannabis use and multiple constructs of impulsivity in outpatient treatment-seeking individuals with 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. This "proof of concept" study will provide Dr. Brezing with training in randomized controlled trial operations, multiple constructs to measure impulsivity, utilization of technology as a measurement tool, and identification of outcomes that may prove important to reductions in cannabis use. Primary Aims: (Aim 1) Examine the effect of lorcaserin compared to placebo, on reductions in cannabis use among treatment-seeking outpatients with CUD, with the primary outcome measured by average weekly mean episodes of any cannabis use (including edibles, vaping, and other variable potency cannabinoid products) per day. (Aim 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). Secondary Aim: If the hypotheses of the Primary Aims are supported, the investigators will examine whether reductions in impulsivity (during weeks 2-3) mediates the effect of lorcaserin on cannabis use (during weeks 8-13). Exploratory Aims: To 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use Disorder
Keywords
cannabis, impulsivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Double Blind Randomized Controlled Trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Encapsulated medication
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lorcaserin XR
Arm Type
Active Comparator
Arm Description
Lorcaserin XR 20mg daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Oral Capsule
Intervention Type
Drug
Intervention Name(s)
Lorcaserin
Other Intervention Name(s)
Belviq
Intervention Description
Lorcaserin XR 20mg per day
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Number of Participants Who Achieved a Reduction in Cannabis Use Per Daily Quartiles
Description
descriptive of cannabis use per day captured in daily quartiles based on self report as collected by the Time Line Follow back. The quartiles defined as follows: 12AM-6AM; 6AM-12PM; 12PM-6PM;6PM-12AM. Participants would report if they used during each of these times.
Time Frame
13 weeks of study or participants length of participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Brezing, MD
Organizational Affiliation
CUMC/NYSPI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia Substance Treatment and Research Service
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Lorcaserin for Cannabis Use Disorder

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