Protocol Details
Just-In-Time Adaptive Interventions for Addictive Behaviors
This study is NOT currently recruiting participants.
Summary
Number | 18-DA-N095 |
Sponsoring Institute | National Institute on Drug Abuse (NIDA) |
Recruitment Detail | Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: 75 Years |
Referral Letter Required | No |
Population Exclusion(s) | Children |
Keywords | CBT;
Mindfulness;
Opiates;
Ecological Monetary Assessment (EMA);
Microrandomized Trial |
Recruitment Keyword(s) | None |
Condition(s) | Addiction |
Investigational Drug(s) | None |
Investigational Device(s) | None |
Intervention(s) | Behavioral: JITAI
Other: Placebo
|
Supporting Site | National Institute on Drug Abuse |
Background:
Many smartphone apps intend to help people with addictions. But not enough is known about how they should work. Researchers want to study an app that gives people the advice they need, just when they need it. This is a JITAI. It stands for Just-In-Time Adaptive Intervention. To create a good JITAI, researchers need to know what approaches work best at different moments.
Objective:
To develop ways to treat addiction with a smartphone app.
Eligibility:
Adults ages 18-75 who use heroin or other opioids
Design:
Participants will be screened in another protocol.
Participants will visit a Baltimore clinic 3 days a week to give urine and breath samples.
Some participants will get their treatment at this clinic.
Participants will answer questions about their personality and stress.
Participants will randomly be assigned to the JITAI group or a comparison group.
Participants will have a training session on using the smartphone app. JITAI participants will also watch a video about the written messages they ll see in the app.
Weeks 3-10: participants will carry a smartphone. Four times a day, it will beep and ask questions. These will be about the participant s activities and mood. The JITAI group will see a short message after. The message is meant to be helpful.
For the first 16 evenings, JITAI participants will get more information on the phone.
Answers to the app s questions will be transferred automatically from the smartphone to secure computers at the NIH.
During the last week, participants can choose the kind of messages they see.
Week 11: participants will return the smartphone and answer questions.
Weeks 12-16, participants who are getting their medicine from the research clinic will be encouraged to transfer to other clinics. Otherwise, they will have their dose slowly reduced to zero.
Eligibility
INCLUSION CRITERIA: Phase 1: Formative interviews.
The enrollment ceiling is 35 outpatients (to collect evaluable data from 30) who meet these criteria: (1) Age 18-75; (2) physical dependence on opioids (by self-report); (3) interest in receiving the types of treatment about which we will be conducting interviews.
Phase 2: Clinical trial with microrandomization.
The enrollment ceiling is 150 outpatients (to collect evaluable data from 85, of whom 50 will be randomized to JITAI, and 35 to EMA control). Treatment may be provided by us in the form of office-based buprenorphine treatment (OBOT) or may be provided elsewhere (Treatment Elsewhere, TE). Participants must meet these criteria:
OBOT participants: (1) Age 18-75; (2) physical dependence on opioids (by positive urine and/or frank opioid withdrawal); (3) interest in receiving the types of treatment we are testing.
Treatment Elsewhere (TE) participants: (1) Age 18-75; (2) receiving methadone or buprenorphine treatment for opioid dependence from a qualified provider in the community; (3) interest in receiving the types of treatment we are testing.
EXCLUSION CRITERIA:
Phase 1: Formative interviews. (1) cognitive impairment severe enough to preclude informed consent or valid interview responses.
Phase 2: Clinical trial with microrandomization.
OBOT participants: (1) History of any DSM-V psychotic disorder; history of bipolar disorder; current Major Depressive Disorder; (2) unresolved symptoms of PTSD that, in the investigators view, would make it risky for the participant to undertake mindfulness exercises (e.g., observing all one s current negative thoughts and emotions) in an unsupervised setting; (3) current dependence on alcohol or sedative-hypnotic, e.g. benzodiazepine (by DSM-V criteria); (4) cognitive impairment severe enough to preclude informed consent or valid self-report; (5) Any condition that interferes with urine collection; (6) medical illness (e.g., cirrhosis, nephritic syndrome, thyroid disease, ischemic heart disease, epilepsy, adrenal insufficiency, etc.) or medications that, in the view of the investigators, would compromise participation in research.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT03538652