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Trial record 38 of 136 for:    cannabis | Recruiting, Enrolling by invitation Studies

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

This study is currently recruiting participants.
Verified January 2017 by New York State Psychiatric Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02932215
First Posted: October 13, 2016
Last Update Posted: January 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
New York State Psychiatric Institute
  Purpose
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.

Condition Intervention Phase
Cannabis Use Disorder Drug: lorcaserin Other: Fitbit Charge HR Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study: Use of a Mobile Health Sensor in an Open Label Trial of Lorcaserin for the Treatment of Cannabis Use Disorder

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Cannabis use [ Time Frame: weeks 1-10 ]
    urine toxicology

  • Adherence to device [ Time Frame: weeks 1-10 ]
    days device is worn

  • Feasibility of implementing mobile health device in treatment trial for CUD [ Time Frame: assessed once at 10weeks (end of study) ]
    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

  • Cannabis Use [ Time Frame: weeks 1-10 ]
    Timeline Followback

  • adherence to medication [ Time Frame: weeks 1- 8 ]
    number of pills taken


Estimated Enrollment: 15
Study Start Date: October 2016
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All participants
All participants will receive open label lorcaserin
Drug: lorcaserin
Open label
Other Name: Belviq
Other: Fitbit Charge HR
This is actually not an intervention- it is a tool to measure activity and sleep; all participants will be receiving one to collect data

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  Contacts and Locations
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): NCT02932215


Contacts
Contact: Chrsitina A Brezing, MD 646-774-6132 brezing@nyspi.columbia.edu

Locations
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    brezing@nyspi.columbia.edu   
Contact: Frances R Levin, MD    6467746137    frl2@columbia.edu   
Sponsors and Collaborators
New York State Psychiatric Institute
  More Information

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02932215     History of Changes
Other Study ID Numbers: 7242
First Submitted: September 19, 2016
First Posted: October 13, 2016
Last Update Posted: January 4, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by New York State Psychiatric Institute:
mobile health device
substance abuse treatment
quality of life
lorcaserin

Additional relevant MeSH terms:
Disease
Marijuana Abuse
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders