AddictionNCT03538652
Just-In-Time Adaptive Interventions for Addictive Behaviors
A study testing Formative Interviews (not an intervention), Cognitive-behavioral therapy (CBT) and Acceptance and commitment therapy (ACT) in people with Addiction, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Addiction
- What is being tested?
- Formative Interviews (not an intervention), Cognitive-behavioral therapy (CBT) and Acceptance and commitment therapy (ACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2020to 13 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- (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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Drug Abuse
Baltimore, Maryland, 21224
About this study
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.
Read more
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.
Read the detailed description
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
- (1) any effect of CBT or ACT versus control moments with no intervention given, and
- (2) preferential advantages of CBT over ACT, and vice versa, as a function of the participant's ability to control (change, escape) a given situation.
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).
- During weeks 1-2, all participants will have baseline assessments of coping styles and personality, and all JITAI participants will be shown a video introducing basic concepts of CBT and ACT.
- For weeks 3-10 (8 weeks), participants will carry smartphones for EMA with or without JITAI.
- During week 11, participants will be readministered some of the assessments from baseline.
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:
- Proximal effects of CBT and ACT messages in the JITAI group: decreases over 20-minute intervals in craving and negative mood, with increases in self-efficacy
- strategy-situation fit in the JITAI group
- group differences in distal effects of treatment (week 11 versus week 2) in terms of self-efficacy and coping flexibility
SECONDARY OUTCOME MEASURES:
- Trait predictors of differential responses to CBT and ACT, in the JITAI group
- group differences in frequency of opioid-positive urine over time
- time courses of responsiveness to ACT vs. CBT, in the JITAI group
- whether the intervention types that benefit participants most when pushed by the app are the same ones participants choose when subsequently given the opportunity to pull interventions.
- Conditions
- Addiction
- Being tested
- Formative Interviews (not an intervention), Cognitive-behavioral therapy (CBT), Acceptance and commitment therapy (ACT), No intervention
- Keywords
- cognitive-behavioral therapy (CBT), Mindfulness, Opiates, Ecological Monetary Assessment (EMA), Microrandomized Trial
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formative Interviews (not an intervention)Other
One hour formative-interview session
Cognitive-behavioral therapy (CBT)Behavioural
In CBT, negative emotional states are viewed as problems to be solved, and the client learns skills to solve them.
Acceptance and commitment therapy (ACT)Behavioural
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.
No interventionOther
Control group with no intervention administered
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: week 2 versus week 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start19 Feb 2020
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Why it stopped: due to the 2020 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- David H Epstein, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538652
- Sponsor's protocol ID
- 999918095
- Other IDs
- 18-DA-N095
- Status last verified
- Aug 2025
- First submitted
- 25 May 2018
- Last updated
- 9 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Just-In-Time Adaptive Interventions for Addictive Behaviors
- ClinicalTrials.gov ID
- NCT03538652
- Acronym / sponsor ID
- 999918095
- Conditions
- Addiction
- Keywords
- cognitive-behavioral therapy (CBT), Mindfulness, Opiates, Ecological Monetary Assessment (EMA), Microrandomized Trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to the 2020 pandemic
- Enrolment
- 9 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Posted 9 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- (1) any effect of CBT or ACT versus control moments with no intervention given, and
- (2) preferential advantages of CBT over ACT, and vice versa, as a function of the participant's ability to control (change, escape) a given situation.
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).
- During weeks 1-2, all participants will have baseline assessments of coping styles and personality, and all JITAI participants will be shown a video introducing basic concepts of CBT and ACT.
- For weeks 3-10 (8 weeks), participants will carry smartphones for EMA with or without JITAI.
- During week 11, participants will be readministered some of the assessments from baseline.
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:
- Proximal effects of CBT and ACT messages in the JITAI group: decreases over 20-minute intervals in craving and negative mood, with increases in self-efficacy
- strategy-situation fit in the JITAI group
- group differences in distal effects of treatment (week 11 versus week 2) in terms of self-efficacy and coping flexibility
SECONDARY OUTCOME MEASURES:
- Trait predictors of differential responses to CBT and ACT, in the JITAI group
- group differences in frequency of opioid-positive urine over time
- time courses of responsiveness to ACT vs. CBT, in the JITAI group
- whether the intervention types that benefit participants most when pushed by the app are the same ones participants choose when subsequently given the opportunity to pull interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1, Arm 1: Formative Interviews | Placebo comparator | Other: Formative Interviews (not an intervention)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. |
| Phase 2, Arm 1: Just-in-time adaptive intervention (JITAI) group | Experimental | 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 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. |
| Phase 2, Arm 2: Ecological momentary assessment (EMA) group (control group) | Active comparator | Other: No interventionOutpatient 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
- 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.
Key exclusion criteria (9 listed)
- Phase 1: Formative interviews. (1) cognitive impairment severe enough to preclude informed consent or valid interview responses.
- Phase 2: Clinical trial with microrandomization.
- (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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formative Interviews (not an intervention)One hour formative-interview session | Other | Phase 1, Arm 1: Formative Interviews |
| Cognitive-behavioral therapy (CBT)In CBT, negative emotional states are viewed as problems to be solved, and the client learns skills to solve them. | Behavioural | Phase 2, Arm 1: Just-in-time adaptive intervention (JITAI) group |
| Acceptance and commitment therapy (ACT)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. | Behavioural | Phase 2, Arm 1: Just-in-time adaptive intervention (JITAI) group |
| No interventionControl group with no intervention administered | Other | Phase 2, Arm 2: Ecological momentary assessment (EMA) group (control group) |
Primary outcome
Change in Opioid Craving Rating
Time frame: Within 20 minutes from receiving app message
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.
Change in Mood Rating
Time frame: Within 20 minutes from receiving app message
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.
Change in Self-efficacy
Time frame: Within 20 minutes from receiving app message
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.
Strategy-situation Fit of Cognitive-behavioral Therapy (CBT)
Time frame: Within 20 minutes from receiving app message
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.
Strategy-situation Fit of Acceptance and Commitment Therapy (ACT)
Time frame: Within 20 minutes from receiving app message
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.
Change in Coping Self-efficacy
Time frame: week 2 versus week 11
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).
Change in Coping-style Flexibility
Time frame: week 2 versus week 11
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).
Change in Flexibility Index Test (FIT)
Time frame: week 2 versus week 11
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David H Epstein, Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formative Interviews (not an intervention), Cognitive-behavioral therapy (CBT) and Acceptance and commitment therapy (ACT) in people with Addiction, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Opioid Craving Rating (time frame: Within 20 minutes from receiving app message). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.