Lorcaserin for Cannabis Use Disorder

NCT03637842 | Terminated Early Phase 1 Results DMC FDA Drug

• 1 other identifier: 7662
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Use Disorder

Keywords

cannabis; impulsivity

Outcome Measures

Primary Outcomes (1)

• 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.

  13 weeks of study or participants length of participation

Study Arms (2)

Lorcaserin XR

ACTIVE COMPARATOR

Lorcaserin XR 20mg daily

Drug: Lorcaserin

Placebo

PLACEBO COMPARATOR

Placebo Oral Capsule

Drug: Placebo oral capsule

Interventions

Lorcaserin DRUG

Lorcaserin XR 20mg per day

Also known as: Belviq

Lorcaserin XR

Placebo oral capsule DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Columbia Substance Treatment and Research Service

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Marijuana Abuse; Impulsive Behavior

Interventions

lorcaserin

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Limitations and Caveats

Study was prematurely terminated due to FDA recall of Lorcaserin.

Results Point of Contact

• Title: Christina Brezing, MD
• Organization: New York State Psychiatric Institute

christina.brezing@nyspi.columbia.edu

6467748181

Study Officials

• Christina Brezing, MD

  CUMC/NYSPI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Encapsulated medication
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychiatrist

Model Details: Double Blind Randomized Controlled Trial

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 20, 2018
• Study Start: August 1, 2019
• Primary Completion: February 29, 2020
• Study Completion: February 29, 2020
• Last Updated: January 28, 2021
• Results First Posted: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)