Just-In-Time Adaptive Interventions for Addictive Behaviors

NCT03538652 | Terminated Results

• 2 other identifiers: 99991809518-DA-N095
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Addiction

Keywords

cognitive-behavioral therapy (CBT); Mindfulness; Opiates; Ecological Monetary Assessment (EMA); Microrandomized Trial

Outcome Measures

Primary Outcomes (8)

• Change in Opioid Craving Rating

  Change in opioid craving within 20 minutes from receiving app messages. Participants designates four one-hour time bands within their typical waking hours, covering morning through late evening. During each of those time bands, the app will push a pair of assessments, given 20 minutes apart. Pre and post assessment ratings will be done using rating scale on the app from 0 to 100 ("0 = not at all" to "100- as much as possible"). Higher number indicates more opioid craving. Participants will complete ratings four times daily for 11 weeks. Analysis will be done in multilevel models.

  Within 20 minutes from receiving app message

• Change in Mood Rating

  Change in mood within 20 minutes from receiving app message. Rating will be done using rating scale on the app from 0 to 100 ("0 = not at all" to "100 = as much as possible"). Higher number indicates more negative mood. Participants will complete ratings four times daily for 11 weeks. Analysis will be done in multilevel models.

  Within 20 minutes from receiving app message

• Change in Self-efficacy

  Change in self-efficacy within 20 minutes from receiving app message. Rating will be done using rating scale on the app from 0 to 100 ("0 = not at all" to "100 = as much as possible"). Higher number indicates more positive self-efficacy. Participants will complete ratings four times daily for 11 weeks. Analysis will be done in multilevel models.

  Within 20 minutes from receiving app message

• Strategy-situation Fit of Cognitive-behavioral Therapy (CBT)

  The analysis will be a test of whether cognitive-behavioral therapy (CBT) messages are most effective in controllable situations and Acceptance and Commitment Therapy (ACT) messages are most effective in noncontrollable situations. A situation will be categorized as noncontrollable when a participant gives a response of less than 50/100 on either of these two "pre" items: (1) "I could easily be somewhere else right now if I wanted," (2) "I could easily get out of what I'm doing right now." Otherwise, will categorize the situation as controllable. Analysis will be done in multilevel models.

  Within 20 minutes from receiving app message

• Strategy-situation Fit of Acceptance and Commitment Therapy (ACT)

  The analysis will be a test of whether cognitive-behavioral therapy (CBT) messages are most effective in controllable situations and Acceptance and Commitment Therapy (ACT) messages are most effective in noncontrollable situations. A situation will be categorized as noncontrollable when a participant gives a response of less than 50/100 on either of these two "pre" items: (1) "I could easily be somewhere else right now if I wanted," (2) "I could easily get out of what I'm doing right now." Otherwise, will categorize the situation as controllable. Analysis will be done in multilevel models.

  Within 20 minutes from receiving app message

• Change in Coping Self-efficacy

  Participants coping self-efficacy will be assessed using the Drug-Taking Confidence Questionnaire (DTCQ-8), an 8-item measure of coping self-efficacy in the context of resisting lapses to drug misuse and administered by clinician. Each item is scored from 0 to 100. Higher score indicates more confidence. Assessment will be administered at weeks 2 and 11. Data will be analyzed via analysis of covariance (ANCOVA), with score from week 2 as the covariate to assess change (change = week 11 minus week 2).

  week 2 versus week 11

• Change in Coping-style Flexibility

  Coping-style flexibility was assessed using the Coping Orientation to Problems Experienced (COPE) questionnaire, a 60-item self-report scale assessing both general coping styles and coping behaviors in specific situations. Each item is rated 1 = I usually don't do this at all, to 4 = I usually do this a lot, with total score of 60 to 240. Higher score indicates improved coping. Assessment will be administered at weeks 2 and 11. Data will be analyzed via analysis of covariance (ANCOVA), with score from week 2 as the covariate to assess change (change = week 11 minus week 2).

  week 2 versus week 11

• Change in Flexibility Index Test (FIT)

  The Flexibility Index Test (FIT-60), a standard measure of traits associated with mindfulness, such as "I observe my feelings without losing myself in them" and "It is OK if I remember something unpleasant," and (reverse scored) "I believe that some of my thoughts are abnormal or bad and that I shouldn't think like that." Each item is rated 0 (completely disagree) to 6 (completely agree) for total score of 0 to 360. Higher score indicates better psychological flexibility. Assessment will be administered at weeks 2 and 11. Data will be analyzed via analysis of covariance (ANCOVA), with score from week 2 as the covariate to assess change (change = week 11 minus week 2).

  week 2 versus week 11

Study Arms (3)

Phase 1, Arm 1: Formative Interviews

PLACEBO COMPARATOR

Outpatient adults who are in treatment for opioid use disorder (OUD) participate in a formative-interview phase (one hour) to drive intervention formation for the trial participants groups.

Other: Formative Interviews (not an intervention)

Phase 2, Arm 1: Just-in-time adaptive intervention (JITAI) group

EXPERIMENTAL

Outpatient adults who are in treatment for opioid use disorder (OUD) will receive electronic messages on their smartphone via an app and education on some basic principles of CBT and ACT. Participants will designate four one-hour time bands within their typical waking hours, covering morning through late evening. During each of those time bands, the app will push a pair of assessments, given 20 minutes apart.

Behavioral: Cognitive-behavioral therapy (CBT); Behavioral: Acceptance and commitment therapy (ACT)

Phase 2, Arm 2: Ecological momentary assessment (EMA) group (control group)

ACTIVE COMPARATOR

Outpatient adults who are in treatment for opioid use disorder (OUD) will receive electronic messages on their smartphone via an app. Participants will designate four one-hour time bands within their typical waking hours, covering morning through late evening. During each of those time bands, the app will push a pair of assessments, given 20 minutes apart.

Other: No intervention

Interventions

Formative Interviews (not an intervention) OTHER

One hour formative-interview session

Phase 1, Arm 1: Formative Interviews

Cognitive-behavioral therapy (CBT) BEHAVIORAL

In CBT, negative emotional states are viewed as problems to be solved, and the client learns skills to solve them.

Phase 2, Arm 1: Just-in-time adaptive intervention (JITAI) group

Acceptance and commitment therapy (ACT) BEHAVIORAL

In ACT, negative emotional states are viewed as a necessary and potentially valuable component of a full life. When they occur, the goal is not to solve them, but to experience them in an observant, curious, nonjudgmental way-a practice referred to as mindfulness.

Phase 2, Arm 1: Just-in-time adaptive intervention (JITAI) group

No intervention OTHER

Control group with no intervention administered

Phase 2, Arm 2: Ecological momentary assessment (EMA) group (control group)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Behavior, Addictive

Interventions

Cognitive Behavioral Therapy; Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Study was closed before any data were collected for the primary outcomes.

Results Point of Contact

• Title: Dr. David Epstein
• Organization: National Institute on Drug Abuse (NIDA)

david.epstein@nih.gov

667-312-5092

Study Officials

• David H Epstein, Ph.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: May 29, 2018
• Study Start: February 19, 2020
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: September 9, 2025
• Results First Posted: September 9, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Access Criteria: We will share some protocol data with our scientific research partners inside or outside the NIH. Research partners outside the NIH sign an agreement with the NIH to share data. This agreement indicates the type of data that can be shared and what can be done with those data.

Locations

US (1)