Understanding Cocaine craving and Use in Environmental Settings
Research type
Research Study
Full title
Understanding Cocaine craving and Use in Environmental Settings
IRAS ID
347472
Contact name
Paolo Deluca
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This study aims to develop and test an integrated smartphone app-based and wearable sensor-initiated Just-In-Time Adaptive Ecological Momentary Assessment (JITA-EMA) and Just-In-Time Adaptive Interventions (JITAI) to provide tailored, personalised and time-sensitive assessments and interventions for cocaine craving and use. This research is funded by the National Institute of Health and Research (NIHR) i4i Addiction Mission. This study will last for one year and is the first study part of a three year funded project.
Objectives include: a. To define the physiological changes for the identification of cocaine use/relapse and craving. b. To develop, train, and refine the algorithm to accurately discriminate these events. c. To understand devices’ acceptability, wearability, and usage patterns and incentivise participants for use and compliance. d. To identify common failure scenarios. e. To develop and implement JITA-EMA smartphone app to capture self-report on participants' mood, stress level, activities, and intensity of craving.
A sample of 90 treatment seeking patients for cocaine dependence and meeting thecriteria will be enrolled in this study.
Participants will be asked to wear the device for four weeks and respond to a smartphone generated JITA-EMA prompt when required. In this way we aim to capture valuable data on the factors associated with cocaine craving and relapse in naturalistic environments.
Inclusion criteria: Primary substance use dependence for cocaine; able and willing to provide informed consentl. Exclusion criteria: evidence of severe mental illness or cognitive impairment, diagnosis of alcohol (or other substance) dependence, or receiving opiate substitute treatment (OST), current participation in other research trials.
Participants will be asked to wear the device for four weeks and answer JITA-EMA when required. JITA-EMA will be presented randomly, self-initiated, or device-initiated. Participants will be responsible for the device and smartphone for the four weeks and will meet with the researcher on Day 1 (first meeting to collect baseline information and train the participant on wearing the device) and the last day, Day 28 (to complete surveys, an interview and return the smartphone and the device). Participants will also have a check-in phone call with the researcher on Day 14.
The results from this study are important for the subsequent two studies within this project grant. Ultimately, the results from this project grant may be able to provide insight into a new treatment for cocaine dependence, which currently has limited treatment options.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
24/NW/0342
Date of REC Opinion
14 Nov 2024
REC opinion
Further Information Favourable Opinion