An interventional study of Formative Interviews (not an intervention) and Cognitive-behavioral therapy (CBT) in Addiction, sponsored by National Institute on Drug Abuse (NIDA). Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-09.
Sponsored by National Institute on Drug Abuse (NIDA) · Not applicable, Interventional, and Treatment
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.
BACKGROUND: Our research group has made extensive use of ecological momentary assessment (EMA) to understand people's daily experiences with opioid craving, use, and lapse. We have also administered clinic-based psychotherapies such as cognitive-behavioral therapy (CBT), in which clients learn to avoid, escape, resolve, or reframe problems (such as stress) that can trigger lapses to drug use. CBT contrasts with ACT (Acceptance and Commitment Therapy), a mindfulness-based approach in which difficult thoughts and feelings are viewed as necessary and potentially valuable components of a full life, to be experienced observantly rather than resolved or reframed. CBT and ACT can and do coexist in a single treatment plan, but we know of no systematic attempt to reconcile their differences. We have also not tried to administer either of them on a mobile device.
OBJECTIVE: To test a just-in-time adaptive intervention (JITAI)-a treatment given when and where it is needed. Our JITAI will be delivered via smartphone app and will combine elements of two widely used treatments for addiction: CBT and ACT. Our goal is not to bring another branded app onto the market, but rather to clarify when and for whom the generic components of such apps are effective or not. This will include determining when CBT is more helpful than ACT and vice versa.
PARTICIPANT POPULATION: Outpatient adults who are physically dependent on opioids - up to 185 enrolled (35 for a formative-interview phase, 150 for a trial) for a target of 115 evaluable (30 interviewees, 85 trial participants). Target enrollment will include 40% women and 60% minorities (mostly African-American). In the trial, some participants will receive buprenorphine in our clinic, and others will be receiving buprenorphine or methadone elsewhere; this is a procedural matter, not a component of the experimental design.
EXPERIMENTAL DESIGN: After a formative-interview phase, the study will be run as a microrandomized trial that will also include a conventionally randomized between-groups clinical-trial component. In microrandomization, interventions are randomized at the momentary level within person; the effect is measured proximally (e.g., 20 minutes later). This is a powerful way to assess the effects of different interventions administered in the field and to examine strategy-situation fit, i.e., whether interventions are differentially effective under specific momentary circumstances. We are powering our study mostly to detect
The between-groups aspect of the design (JITAI group versus EMA-only control group) is needed to demonstrate an effect of our JITAI on traditional, distal measures of outcome, such as reductions in opioid use.
METHODS: In the formative-interview phase, we will conduct interviews with people in treatment for OUD who express interest in using a mobile treatment app. We will ask them about day-to-day challenges they currently face in maintaining progress toward their treatment goals, and ask them what might be helpful. Then we will show them item lists, onscreen mockups, and/or functional demos, and we will ask interviewees to comment on the app's likely usefulness, its likely pitfalls, and how we could improve it.
In the clinical trial, participants will be randomized to one of two groups (JITAI vs. EMA-only control).
Participants receiving buprenorphine from us will then be offered a dose taper or encouraged to transfer to continued treatment elsewhere. All participants will come to our clinic thrice weekly for urine testing throughout participation.
PRIMARY OUTCOME MEASURES:
SECONDARY OUTCOME MEASURES:
540 studies on the registry are indexed under Behavior, Addictive; 134 are open to participants now.
This study's enrollment of 9 is below the median of 72 across 391 interventional studies indexed under Behavior, Addictive.
Browse Behavior, Addictive studies →National Institute on Drug Abuse (NIDA) is the lead sponsor of 388 studies on the registry; 19 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
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)
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)
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
One hour formative-interview session
In CBT, negative emotional states are viewed as problems to be solved, and the client learns skills to solve them.
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.
Control group with no intervention administered
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: week 2 versus week 11
| Milestone | Phase 1, Arm 1: Formative Interviews | Phase 2, Arm 1: Just-in-time Adaptive Intervention (JITAI) Group | Phase 2, Arm 2: Ecological Momentary Assessment (EMA) Group (Control Group) |
|---|---|---|---|
| Started | 9 | 0 | 0 |
| Completed | 9 | 0 | 0 |
| Not completed | 0 | 0 | 0 |
| Milestone | Phase 1, Arm 1: Formative Interviews | Phase 2, Arm 1: Just-in-time Adaptive Intervention (JITAI) Group | Phase 2, Arm 2: Ecological Momentary Assessment (EMA) Group (Control Group) |
|---|---|---|---|
| Started | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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).
No measurements were reported for this outcome.
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).
No measurements were reported for this outcome.
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).
No measurements were reported for this outcome.
Collected over One day for participants in the formative interview (phase 1). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 1, Arm 1: Formative Interviews | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Categorical(Participants) | Phase 1, Arm 1: Formative Interviews |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 9 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Phase 1, Arm 1: Formative Interviews |
|---|---|
| Female | 3 |
| Male | 6 |
| Ethnicity (NIH/OMB)(Participants) | Phase 1, Arm 1: Formative Interviews |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 8 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Phase 1, Arm 1: Formative Interviews |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 7 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Phase 1, Arm 1: Formative Interviews |
|---|---|
| United States | 9 |
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Plan to share: Yes — Some health information collected may be placed into one or more scientific databases after it has been stripped of identifiers such as name, address or account number, so that it may be used for future research on any topic and shared broadly for research purposes. A researcher who wants to study the information must apply to the database and be approved.
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