Ignite Creation Date:
2024-05-06 @ 9:15 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02932215
Status:
COMPLETED
Last Update Posted:
2019-10-11
First Post:
2016-09-19
Brief Title:
Use of a Mobile Health Sensor in an Open Label Trial of Lorcaserin for the Treatment of Cannabis Use Disorder
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Pilot Study Use of a Mobile Health Sensor in an Open Label Trial of Lorcaserin for the Treatment of Cannabis Use Disorder
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None