Use of a Mobile Health Sensor in an Open Label Trial of Lorcaserin for the Treatment of Cannabis Use Disorder

NCT02932215 | Completed Phase 1 DMC

• 1 other identifier: 7242
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 10 week, open-label, prospective study, involving 10 volunteer participants with cannabis use disorder to test the feasibility and safety of using lorcaserin in addition to the feasibility, likability, and utility of a mobile sensor device in cannabis users. The study will be entirely outpatient. Upon study entry, participants will begin clinic visits at the Substance Treatment and Research Service (STARS) clinic. All consented participants will receive a Fitbit Charge HR device in week 1 to wear for the entire study and receive lorcaserin beginning in week 2 for a total of 8 weeks (weeks 2-9). At the beginning of week 10 following discontinuation of lorcaserin, the participants will continue to wear the Fitbit Charge HR device for this final week following completion of the medication trial. All participants will visit the clinic twice weekly to provide urine toxicology on THC, report on adverse events, complete additional assessments (outlined below), and upload de-identified data from the Fitbit Charge HR device to the secure encrypted Fitabase database. Study assessments will be collected at baseline, throughout the study, and 1 week following medication discontinuation. All participants will also receive medical management, a medication adherence focused psychosocial intervention that facilitates compliance with study medication and other study procedures, including adherence to wearing the Fitbit Charge HR device, and promotes abstinence from cannabis and other substances. Progressive voucher incentives will be provided for compliance with visit attendance and study procedures.

Conditions

Cannabis Use Disorder

Keywords

mobile health device; substance abuse treatment; quality of life; lorcaserin

Outcome Measures

Primary Outcomes (5)

• Cannabis use

  urine toxicology

  weeks 1-10

• Adherence to device

  days device is worn

  weeks 1-10

• Feasibility of implementing mobile health device in treatment trial for CUD

  5 question self-report on likability of device; eg: Question 1: did you like wearing the mobile sensor device to track your progress during treatment? Yes or No; Question 2: Would you continue to wear the mobile sensor device to track your behaviors? Yes or No; etc

  assessed once at 10weeks (end of study)

• Cannabis Use

  Timeline Followback

  weeks 1-10

• adherence to medication

  number of pills taken

  weeks 1- 8

Study Arms (1)

All participants

EXPERIMENTAL

All participants will receive open label lorcaserin

Drug: lorcaserin; Other: Fitbit Charge HR

Interventions

lorcaserin DRUG

Open label

Also known as: Belviq

All participants

Fitbit Charge HR OTHER

This is actually not an intervention- it is a tool to measure activity and sleep; all participants will be receiving one to collect data

All participants

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals between the ages of 18-60
• 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 access to a mobile device with IOS7 or Android 4.4.2 capabilities or more recent operating systems
• Not underweight (Defined as BMI ≥18.5)

You may not qualify if:

• Lifetime history of DSM-V diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
• Current DSM-V criteria for any other 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 a psychotropic medication for at least 3 months may be included if in the investigator's opinion the psychotropic medication the patient is taking is compatible with the study medication (lorcaserin).
• Individuals who meet DSM-V criteria for any 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 (blood pressure \> 140/90), uncontrolled diabetes, pulmonary hypertension or heart disease
• Legally mandated to participate in a substance use disorder treatment program
• Current or recent history of significant violent orsuicidal behavior, risk for suicide or homicide psychiatrist
• Currently meets DSM-V diagnosis for an eating disorder or is underweight (defined as 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, or medications metabolized by CYP2D6 (thioridazine, tamoxifen, metoprolol, aripiprazole, codeine, etc)
• No access to mobile device with IOS7 or Android 4.4.2 capabilities or more recent operating systems

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

Columbia Substance Treatment and Research Service

New York, New York, 10019, United States

Location

Related Publications (1)

• Brezing CA, Sibai M, Choi CJ, Mitra S, Mariani JJ, Naqvi N, Mahony AL, Brooks D, Pavlicova M, Levin FR. Open Label Pilot of Lorcaserin (a serotonin 2C-receptor agonist) for Cannabis Use Disorder. J Subst Use. 2024;29(4):487-494. doi: 10.1080/14659891.2023.2202760. Epub 2023 May 10.

  PMID: 39021751 DERIVED

MeSH Terms

Interventions

lorcaserin

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research psychiatrist

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: October 13, 2016
• Study Start: October 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 17, 2019
• Last Updated: October 11, 2019

Record last verified: 2019-10

Locations

US (1)