Verified October 2016 by New York State Psychiatric Institute
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT02932215
First received: September 19, 2016
Last updated: October 12, 2016
Last verified: October 2016
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.
| Cannabis Use Disorder | Drug: lorcaserin Other: Fitbit Charge HR |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
| 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) |
| 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 |
| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02932215
| Columbia Substance Treatment and Research Service | |
| New York, New York, United States, 10019 | |
| Contact: Christina A Brezing, MD 646-774-6132 brezing@nullnyspi.columbia.edu | |
| Contact: Frances R Levin, MD 6467746137 frl2@nullcolumbia.edu | |
New York State Psychiatric Institute
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT02932215 History of Changes |
| Other Study ID Numbers: | 7242 |
| Study First Received: | September 19, 2016 |
| Last Updated: | October 12, 2016 |
| Health Authority: | United States: Food and Drug Administration |
| Individual Participant Data | |
| 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 |
ClinicalTrials.gov processed this record on October 13, 2016