Trial Outcomes & Findings for Just-In-Time Adaptive Interventions for Addictive Behaviors (NCT NCT03538652)
NCT ID: NCT03538652
Last Updated: 2025-09-09
Results Overview
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.
TERMINATED
NA
9 participants
Within 20 minutes from receiving app message
2025-09-09
Participant Flow
Participant milestones
| Measure |
Phase 1, Arm 1: Formative Interviews
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
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)
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.
|
|---|---|---|---|
|
Phase 1
STARTED
|
9
|
0
|
0
|
|
Phase 1
COMPLETED
|
9
|
0
|
0
|
|
Phase 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Phase 2
STARTED
|
0
|
0
|
0
|
|
Phase 2
COMPLETED
|
0
|
0
|
0
|
|
Phase 2
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Just-In-Time Adaptive Interventions for Addictive Behaviors
Baseline characteristics by cohort
| Measure |
Phase 1, Arm 1: Formative Interviews
n=9 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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 20 minutes from receiving app messagePopulation: Per protocol document, outcome analysis applies only to the Just-in-time adaptive intervention (JITAI) group. Study was closed before any data were collected for the primary outcomes.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Within 20 minutes from receiving app messagePopulation: Per protocol document, outcome analysis applies only to the Just-in-time adaptive intervention (JITAI) group. Study was closed before any data were collected for the primary outcomes.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Within 20 minutes from receiving app messagePopulation: Per protocol document, outcome analysis applies only to the Just-in-time adaptive intervention (JITAI) group. Study was closed before any data were collected for the primary outcomes.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Within 20 minutes from receiving app messagePopulation: Per protocol document, outcome analysis applies only to the Just-in-time adaptive intervention (JITAI) group. Study was closed before any data were collected for the primary outcomes.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Within 20 minutes from receiving app messagePopulation: Per protocol document, outcome analysis applies only to the Just-in-time adaptive intervention (JITAI) group. Study was closed before any data were collected for the primary outcomes.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: week 2 versus week 11Population: Study was closed before any data were collected for the primary outcomes.
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).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: week 2 versus week 11Population: Study was closed before any data were collected for the primary outcomes.
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).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: week 2 versus week 11Population: Study was closed before any data were collected for the primary outcomes.
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).
Outcome measures
Outcome data not reported
Adverse Events
Phase 1, Arm 1: Formative Interviews
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. David Epstein
National Institute on Drug Abuse (NIDA)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place