Cannabis Use DisorderPhase 1NCT02932215
Use of a Mobile Health Sensor in an Open Label Trial of Lorcaserin for the Treatment of Cannabis Use Disorder
A Phase 1 study testing lorcaserin and Fitbit Charge HR in people with Cannabis Use Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cannabis Use Disorder
- What is being tested?
- lorcaserin and Fitbit Charge HR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 17 Jan 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia Substance Treatment and Research Service
New York, New York, 10019
About this study
Official title: Pilot Study: Use of a Mobile Health Sensor in an Open Label Trial of Lorcaserin for the Treatment of Cannabis Use Disorder
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.
Read the detailed description
Design Overview: 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 mobile 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 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 device to a secure encrypted 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 device, and promotes abstinence from cannabis and other substances. Progressive voucher incentives will be provided for compliance with visit attendance and study procedures.
The specific aims of the project are:
- To determine whether lorcaserin is associated with a reduction from baseline in cannabis use in individuals with cannabis use disorder seeking treatment.
- To determine the tolerability of lorcaserin in this population.
- To evaluate the feasibility and likability of incorporating a mobile health sensor device in a treatment study for cannabis use disorder.
The primary outcome measures are:
- Lorcaserin will significantly reduce cannabis use during the study period as measured by self-report (Timeline Followback) and creatinine-normalized quantitative THC urine levels.
- Lorcaserin will be well tolerated in participants with cannabis use disorder as measured by the proportion of participants completing the study, adherence to medication, and the proportion of participants experiencing adverse events.
- Participants will find it feasible and likeable to utilize the Fitbit Charge HRTM in the study as measured by selfreport assessment of liking and adherence to wearing the device
Secondary aims include:
- To evaluate the effect of medication treatment for cannabis use disorder on activity, sleep, stress, and quality of life as measured with a mobile sensor device and self-report assessments in individuals with cannabis use disorder.
- To evaluate the correlation between summarized Fitbit Charge HR health sensor measures and self-report assessments of sleep, stress, and quality of life in addition to participants' use of cannabis and cannabis withdrawal at baseline, during, and after a treatment trial.
The secondary outcome measures include:
- Medication treatment will increase positive health behaviors including activity and improve sleep (increase total sleep time and percentage deep sleep) in addition to decreasing stress and improving quality of life as measured by summarized daily total steps, sleep duration and quality, and summarized stress score measured with device in conjunction with improvement in the Pittsburgh Sleep Quality Inventory (PSQI), decreased Perceived Stress Scale score (PSS), and improvement on Quality of Life, Enjoyment, and Satisfaction Questionnaire (QLESQ), as compared to baseline. Negative health behaviors (poor sleep, decreased activity, increased stress) will be highest within subjects before starting treatment and with initial abstinence from cannabis when withdrawal symptoms are most prominent. Positive health behaviors will increase during treatment within subject, and particularly towards the second half of treatment as reduction in cannabis use or abstinence is sustained.
- The device measures and self-report measures will directly correlate, as expected; ie: increased sleep and increased % of deep sleep will correlate with higher PSQI scores. When participants are using baseline levels of cannabis or are in cannabis withdrawal, they will have device measures consistent with negative health behaviors (poor sleep, decreased activity, increased stress). When they reduce cannabis use or achieve abstinence for a sustained period (any 14 days), an association with positive health behaviors as measured by the mobile device (adequate sleep, adequate activity, decreased stress) will increase.
The objective of the pilot is to obtain preliminary data on cannabis use patterns, tolerability of this medication, and sleep, quality of life and activity patterns in individuals with cannabis use disorder before conducting a larger trial with lorcaserin and to inform future applications of mobile sensors to cannabis use disorder treatment.
- Conditions
- Cannabis Use Disorder
- Being tested
- lorcaserin, Fitbit Charge HR
- Keywords
- mobile health device, substance abuse treatment, quality of life, lorcaserin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lorcaserinDrug
Also called Belviq
Open label
Fitbit Charge HROther
This is actually not an intervention- it is a tool to measure activity and sleep; all participants will be receiving one to collect data
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | All participants will receive open label lorcaserin Receives: Drug: lorcaserin; Other: Fitbit Charge HR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cannabis use
urine toxicology
Measured: weeks 1-10
Adherence to device
days device is worn
Measured: 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
Measured: assessed once at 10weeks (end of study)
Cannabis Use
Timeline Followback
Measured: weeks 1-10
adherence to medication
number of pills taken
Measured: weeks 1- 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2019
- Study completion17 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cannabis Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Ann Brezing, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932215
- Sponsor's protocol ID
- 7242
- Status last verified
- Oct 2019
- First submitted
- 19 Sep 2016
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 39021751
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Use of a Mobile Health Sensor in an Open Label Trial of Lorcaserin for the Treatment of Cannabis Use Disorder
- ClinicalTrials.gov ID
- NCT02932215
- Acronym / sponsor ID
- 7242
- Conditions
- Cannabis Use Disorder
- Keywords
- mobile health device, substance abuse treatment, quality of life, lorcaserin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Design Overview: 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 mobile 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 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 device to a secure encrypted 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 device, and promotes abstinence from cannabis and other substances. Progressive voucher incentives will be provided for compliance with visit attendance and study procedures.
The specific aims of the project are:
- To determine whether lorcaserin is associated with a reduction from baseline in cannabis use in individuals with cannabis use disorder seeking treatment.
- To determine the tolerability of lorcaserin in this population.
- To evaluate the feasibility and likability of incorporating a mobile health sensor device in a treatment study for cannabis use disorder.
The primary outcome measures are:
- Lorcaserin will significantly reduce cannabis use during the study period as measured by self-report (Timeline Followback) and creatinine-normalized quantitative THC urine levels.
- Lorcaserin will be well tolerated in participants with cannabis use disorder as measured by the proportion of participants completing the study, adherence to medication, and the proportion of participants experiencing adverse events.
- Participants will find it feasible and likeable to utilize the Fitbit Charge HRTM in the study as measured by selfreport assessment of liking and adherence to wearing the device
Secondary aims include:
- To evaluate the effect of medication treatment for cannabis use disorder on activity, sleep, stress, and quality of life as measured with a mobile sensor device and self-report assessments in individuals with cannabis use disorder.
- To evaluate the correlation between summarized Fitbit Charge HR health sensor measures and self-report assessments of sleep, stress, and quality of life in addition to participants' use of cannabis and cannabis withdrawal at baseline, during, and after a treatment trial.
The secondary outcome measures include:
- Medication treatment will increase positive health behaviors including activity and improve sleep (increase total sleep time and percentage deep sleep) in addition to decreasing stress and improving quality of life as measured by summarized daily total steps, sleep duration and quality, and summarized stress score measured with device in conjunction with improvement in the Pittsburgh Sleep Quality Inventory (PSQI), decreased Perceived Stress Scale score (PSS), and improvement on Quality of Life, Enjoyment, and Satisfaction Questionnaire (QLESQ), as compared to baseline. Negative health behaviors (poor sleep, decreased activity, increased stress) will be highest within subjects before starting treatment and with initial abstinence from cannabis when withdrawal symptoms are most prominent. Positive health behaviors will increase during treatment within subject, and particularly towards the second half of treatment as reduction in cannabis use or abstinence is sustained.
- The device measures and self-report measures will directly correlate, as expected; ie: increased sleep and increased % of deep sleep will correlate with higher PSQI scores. When participants are using baseline levels of cannabis or are in cannabis withdrawal, they will have device measures consistent with negative health behaviors (poor sleep, decreased activity, increased stress). When they reduce cannabis use or achieve abstinence for a sustained period (any 14 days), an association with positive health behaviors as measured by the mobile device (adequate sleep, adequate activity, decreased stress) will increase.
The objective of the pilot is to obtain preliminary data on cannabis use patterns, tolerability of this medication, and sleep, quality of life and activity patterns in individuals with cannabis use disorder before conducting a larger trial with lorcaserin and to inform future applications of mobile sensors to cannabis use disorder treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Drug: lorcaserin, Other: Fitbit Charge HRAll participants will receive open label lorcaserin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lorcaserinAlso: BelviqOpen label | Drug | All participants |
| Fitbit Charge HRThis is actually not an intervention- it is a tool to measure activity and sleep; all participants will be receiving one to collect data | Other | All participants |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2019.
- Derived from this study: PubMed 39021751Brezing 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lorcaserin and Fitbit Charge HR in people with Cannabis Use Disorder, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cannabis use (time frame: weeks 1-10). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02932215, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2019.