Use of a Mobile Health Sensor in an Open Label Trial of Lorcaserin for the Treatment of Cannabis Use Disorder
Condition: Cannabis Use Disorder
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 1

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.
    

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:

        1. To determine whether lorcaserin is associated with a reduction from baseline in cannabis
           use in individuals with cannabis use disorder seeking treatment.

        2. To determine the tolerability of lorcaserin in this population.

        3. 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:

        1. Lorcaserin will significantly reduce cannabis use during the study period as measured by
           self-report (Timeline Followback) and creatinine-normalized quantitative THC urine
           levels.

        2. 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.

        3. 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:

        1. 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.

        2. 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:

        1. 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.

        2. 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.
    

Intervention name(s): lorcaserin; Fitbit Charge HR
Intervention type(s): Drug; Other
Intervention description(s): Open label; This is actually not an intervention- it is a tool to measure activity and sleep; all participants will be receiving one to collect data
Other intervention name(s): Belviq
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mobile health device; substance abuse treatment; quality of life; lorcaserin