Just-In-Time Adaptive Interventions for Addictive Behaviors

Stopped early · Not applicable

Conditions studied: Addiction

In brief

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 Just-In-Time Adaptive Intervention (JITAI). 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 will 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 participants' 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.

Key facts

Study ID: NCT03538652
Run by: National Institute on Drug Abuse (NIDA)
People needed: 9
Starts: 2020-02-19
Expected to finish: 2020-03-13
Last updated by the study team: 2025-09-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

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.

Where it is running

National Institute on Drug Abuse — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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