Opioid-Related DisordersNCT05336188
Neurocognitive Mechanisms Underlying Smartphone-Assisted Prevention of Relapse in Opioid Use Disorder
A study testing Smartphone in people with Opioid-Related Disorders and Mobile Applications, run by University of Arkansas at 1 site in United States.
Trial summary
The proposed clinical trial would evaluate the use of smartphone applications ("apps", which have well-established efficacy in reducing cigarette and alcohol use) to prevent relapse among patients receiving medication-assisted treatment for opioid use disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-Related Disorders, Mobile Applications, Opiate Substitution Treatment
- What is being tested?
- Smartphone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2023to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sex: male or female
- Age: 18 years and older
- (MRI sub-study): Age: 18-50 years old
- In Phase I treatment of MAT for opioid-use disorder. (Phase I indicates that patient is receiving no more than one week of take-home medications at each weekly clinic visit.)
- Must be willing to use a smartphone if randomized to the smartphone intervention arm
- (MRI sub-study): Native English-speaking
Who cannot join
- (MRI) Medical history: A history of neurological, cardiovascular, or infectious disease would exclude study participation. A loss of consciousness of 20 or more min or other evidence of brain trauma also would be exclusionary.
- (MRI) Pregnancy: A positive test for pregnancy prior to fMRI would exclude participation, due to unknown effect of high-field MRI on developing fetus.
- (MRI) MRI contraindications: Exclusion criteria for MRI include (1) the presence of non-removable internal (e.g., cardiac pacemakers, aneurysm clips, artificial joints) or external (e.g., piercings, orthodontics) ferromagnetic objects; (2) claustrophobia in a confined MRI environment; (3) medications that interfere with hemodynamic coupling (e.g., beta blockers); (4) hypersensitivity to loud noise; or (5) a body circumference exceeding 60cm due to broad shoulders or morbid obesity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Brain Imaging Research Center
Little Rock, Arkansas, 72227
About this study
The proposed clinical trial would evaluate the use of smartphone applications ("apps", which have well-established efficacy in reducing cigarette and alcohol use) to prevent relapse among patients receiving medication-assisted treatment for opioid use disorder. In addition to standard app-based self-monitoring of drug use and personalized feedback, project innovation is enhanced by the proposed use of location-tracking technology for targeted, personalized intervention when participants enter self-identified areas of high risk for relapse. Furthermore, the proposed sub-study would use longitudinal functional neuroimaging to elucidate the brain-cognition relationships underlying individual differences in treatment outcomes, offering broad significance for understanding and enhancing the efficacy of this and other app-based interventions.
Read the detailed description
The rising public health burden of opioid misuse, coupled with high relapse rates among individuals seeking treatment for opioid use disorder, necessitates novel interventions for improving opioid-related treatment response. Mobile technology such as smartphone-based applications ("apps") represent one such intervention. Although smartphone apps are effective in reducing cigarette and alcohol use, their efficacy for reducing opioid use has not yet been established. The proposed clinical trial would evaluate the app OptiMAT ("Optimizing Medication-Assisted Treatment") to prevent relapse among patients receiving medication-assisted treatment for opioid use disorder. OptiMAT implements two features shown to be effective for reducing substance use: daily self-monitoring of opiate use coupled with personalized feedback. Aim 1 would accrue 255 participants with 1:1 randomization into two arms (OptiMAT vs. Monitoring only) to evaluate differences in monthly opioid use at six months post-enrollment. Aim 2 would enroll a subset of participants (N=120; 60 per arm) into a longitudinal functional neuroimaging (fMRI) study to model the neurocognitive mechanisms underlying individual differences in treatment response. Two putative mechanisms (attentional bias for drug cues and cue-induced craving) promoting abstinence would be studied. Aim 3 would explore the use of location-based geographic ecological momentary assessment (GEMA) for targeted intervention when participants enter self-identified areas of high risk for relapse. Collectively, the proposed aims would (1) evaluate mobile technology applications for reducing opiate use, (2) understand the neurocognitive mechanisms of action to improve upon this and other apps aiming to reduce drug use, and (3) evaluate the role of personalized, contextually-relevant intervention to promote successful treatment outcomes.
- Conditions
- Opioid-Related Disorders, Mobile Applications, Opiate Substitution Treatment, Magnetic Resonance Imaging, Craving, Attentional Bias
- Being tested
- Smartphone
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartphoneDevice
Also called OptiMAT, "Optimizing MAT"
Adjunctive Smartphone app for improving MAT outcomes
| Study group | Role | What they receive |
|---|---|---|
| Smartphone | Experimental | Participants randomized into the Smartphone app arm would use the smartphone app OptiMAT in conjunction with treatment as usual (TAU). Participants would use OptiMAT to complete daily self-assessments of opiate misuse, opiate craving, opiate withdrawal, and mood. The app will personalized feedback for maintaining abstinence goals. The app would also use geographic ecological momentary assessment (GEMA) to intervene via push notification when participants enter areas previously identified as high-risk for opiate use. Receives: Device: Smartphone |
| Monitoring Only | No intervention | Participants randomized into the Monitoring Only arm would undergo treatment as usual (TAU) but without the smartphone app. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinalysis - Week 0 (Intake)
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 1 day
Urinalysis - Week 1
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 1 week
Urinalysis - Week 2
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 2 weeks
Urinalysis - Week 3
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 3 weeks
Urinalysis - Week 4
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 4 weeks
Urinalysis - Week 5
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 5 weeks
Urinalysis - Week 6
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 6 weeks
Urinalysis - Week 7
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 7 weeks
Urinalysis - Week 8
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 8 weeks
Urinalysis - Week 9
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 9 weeks
Urinalysis - Week 10
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 10 weeks
Urinalysis - Week 11
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 11 weeks
Urinalysis - Week 12
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 12 weeks
Urinalysis - Week 13
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 13 weeks
Urinalysis - Week 14
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 14 weeks
Urinalysis - Week 15
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 15 weeks
Urinalysis - Week 16
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 16 weeks
Urinalysis - Week 17
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 17 weeks
Urinalysis - Week 18
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 18 weeks
Urinalysis - Week 19
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 19 weeks
Urinalysis - Week 20
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 20 weeks
Urinalysis - Week 21
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 21 weeks
Urinalysis - Week 22
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 22 weeks
Urinalysis - Week 23
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 23 weeks
Urinalysis - Week 24
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 24 weeks
Urinalysis - Week 25
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 25 weeks
Urinalysis - Week 26
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Measured: 26 weeks
Secondary outcomes (33)
TLFB - Month 0 (Intake)
Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
Measured: 1 day
TLFB - Month 1
Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
Measured: 1 month
TLFB - Month 2
Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
Measured: 2 months
TLFB - Month 3
Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
Measured: 3 months
TLFB - Month 4
Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
Measured: 4 months
TLFB - Month 5
Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
Measured: 5 months
TLFB - Month 6
Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
Measured: 6 months
Treatment Continuation - Week 1
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
Measured: 1 week
Treatment Continuation - Week 2
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
Measured: 2 weeks
Treatment Continuation - Week 3
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
Measured: 3 weeks
Treatment Continuation - Week 4
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
Measured: 4 weeks
Treatment Continuation - Week 5
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
Measured: 5 weeks
Treatment Continuation - Week 6
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
Measured: 6 weeks
Treatment Continuation - Week 7
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
Measured: 7 weeks
Treatment Continuation - Week 8
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
Measured: 8 weeks
Treatment Continuation - Week 9
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
Measured: 9 weeks
Treatment Continuation - Week 10
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
Measured: 10 weeks
Treatment Continuation - Week 11
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
Measured: 11 weeks
Treatment Continuation - Week 12
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
Measured: 12 weeks
Treatment Continuation - Week 13
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
Measured: 13 weeks
Treatment Continuation - Week 14
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
Measured: 14 weeks
Treatment Continuation - Week 15
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
Measured: 15 weeks
Treatment Continuation - Week 16
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
Measured: 16 weeks
Treatment Continuation - Week 17
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
Measured: 17 weeks
Treatment Continuation - Week 18
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
Measured: 18 weeks
Treatment Continuation - Week 19
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
Measured: 19 weeks
Treatment Continuation - Week 20
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
Measured: 20 weeks
Treatment Continuation - Week 21
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
Measured: 21 weeks
Treatment Continuation - Week 22
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
Measured: 22 weeks
Treatment Continuation - Week 23
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
Measured: 23 weeks
Treatment Continuation - Week 24
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
Measured: 24 weeks
Treatment Continuation - Week 25
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
Measured: 25 weeks
Treatment Continuation - Week 26
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start16 May 2023
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- 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
- Model description
- Participants will be randomized to one of two arms: a Monitor Only arm (aka treatment-as-usual, MAT only) and a Smartphone arm (aka OptiMAT plus MAT).
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew James, Ph.D., Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336188
- Sponsor's protocol ID
- 274084
- Status last verified
- Apr 2026
- First submitted
- 21 Mar 2022
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Persuant to NIH/NIDA policy for transparency and rigorous experimental design (NOT-MH-14-004, NOT-DA-14-007), all published data will be de-identified and made publicly available through clinical and neuroimaging repositories such as the ENIGMA Addiction Working Group, INDI, or OpenFMRI. To promote open science, data infrastructure will follow the HCP universal BIDS format.
Publications
Bollinger M, Thompson RG Jr, Mancino MJ, Hasin DS, James GA. Geospatial ecological momentary assessment (GEMA) for opioid use disorder: Protocol for a just-in-time adaptive intervention. J Subst Use Addict Treat. 2026 Jul;186:209946. doi: 10.1016/j.josat.2026.209946. Epub 2026 Mar 19.
PubMed 41862055Thompson RG Jr, Bollinger M, Mancino MJ, Hasin D, Han X, Bush KA, Kilts CD, James GA. Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. Trials. 2023 Apr 4;24(1):255. doi: 10.1186/s13063-023-07213-3.
PubMed 37016394Thompson RG Jr, Bollinger M, Mancino M, Hasin D, Han X, Bush KA, Kilts CD, James GA. Smartphone intervention to optimize medication assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. Res Sq [Preprint]. 2023 Feb 15:rs.3.rs-2511936. doi: 10.21203/rs.3.rs-2511936/v1.
PubMed 36824884
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Mechanisms Underlying Smartphone-Assisted Prevention of Relapse in Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT05336188
- Acronym / sponsor ID
- 274084
- Conditions
- Opioid-Related Disorders, Mobile Applications, Opiate Substitution Treatment, Magnetic Resonance Imaging, Craving, Attentional Bias
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 16 May 2023 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed clinical trial would evaluate the use of smartphone applications ("apps", which have well-established efficacy in reducing cigarette and alcohol use) to prevent relapse among patients receiving medication-assisted treatment for opioid use disorder. In addition to standard app-based self-monitoring of drug use and personalized feedback, project innovation is enhanced by the proposed use of location-tracking technology for targeted, personalized intervention when participants enter self-identified areas of high risk for relapse. Furthermore, the proposed sub-study would use longitudinal functional neuroimaging to elucidate the brain-cognition relationships underlying individual differences in treatment outcomes, offering broad significance for understanding and enhancing the efficacy of this and other app-based interventions.
Detailed description
The rising public health burden of opioid misuse, coupled with high relapse rates among individuals seeking treatment for opioid use disorder, necessitates novel interventions for improving opioid-related treatment response. Mobile technology such as smartphone-based applications ("apps") represent one such intervention. Although smartphone apps are effective in reducing cigarette and alcohol use, their efficacy for reducing opioid use has not yet been established. The proposed clinical trial would evaluate the app OptiMAT ("Optimizing Medication-Assisted Treatment") to prevent relapse among patients receiving medication-assisted treatment for opioid use disorder. OptiMAT implements two features shown to be effective for reducing substance use: daily self-monitoring of opiate use coupled with personalized feedback. Aim 1 would accrue 255 participants with 1:1 randomization into two arms (OptiMAT vs. Monitoring only) to evaluate differences in monthly opioid use at six months post-enrollment. Aim 2 would enroll a subset of participants (N=120; 60 per arm) into a longitudinal functional neuroimaging (fMRI) study to model the neurocognitive mechanisms underlying individual differences in treatment response. Two putative mechanisms (attentional bias for drug cues and cue-induced craving) promoting abstinence would be studied. Aim 3 would explore the use of location-based geographic ecological momentary assessment (GEMA) for targeted intervention when participants enter self-identified areas of high risk for relapse. Collectively, the proposed aims would (1) evaluate mobile technology applications for reducing opiate use, (2) understand the neurocognitive mechanisms of action to improve upon this and other apps aiming to reduce drug use, and (3) evaluate the role of personalized, contextually-relevant intervention to promote successful treatment outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of two arms: a Monitor Only arm (aka treatment-as-usual, MAT only) and a Smartphone arm (aka OptiMAT plus MAT).
| Arm | Type | Receives |
|---|---|---|
| Smartphone | Experimental | Device: SmartphoneParticipants randomized into the Smartphone app arm would use the smartphone app OptiMAT in conjunction with treatment as usual (TAU). Participants would use OptiMAT to complete daily self-assessments of opiate misuse, opiate craving, opiate withdrawal, and mood. The app will personalized feedback for maintaining abstinence goals. The app would also use geographic ecological momentary assessment (GEMA) to intervene via push notification when participants enter areas previously identified as high-risk for opiate use. |
| Monitoring Only | No intervention | –Participants randomized into the Monitoring Only arm would undergo treatment as usual (TAU) but without the smartphone app. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Sex: male or female
- Age: 18 years and older
- (MRI sub-study): Age: 18-50 years old
- In Phase I treatment of MAT for opioid-use disorder. (Phase I indicates that patient is receiving no more than one week of take-home medications at each weekly clinic visit.)
- Must be willing to use a smartphone if randomized to the smartphone intervention arm
Key exclusion criteria (3 listed)
- (MRI) Medical history: A history of neurological, cardiovascular, or infectious disease would exclude study participation. A loss of consciousness of 20 or more min or other evidence of brain trauma also would be exclusionary.
- (MRI) Pregnancy: A positive test for pregnancy prior to fMRI would exclude participation, due to unknown effect of high-field MRI on developing fetus.
- (MRI) MRI contraindications: Exclusion criteria for MRI include (1) the presence of non-removable internal (e.g., cardiac pacemakers, aneurysm clips, artificial joints) or external (e.g., piercings, orthodontics) ferromagnetic objects; (2) claustrophobia in a confined MRI environment; (3) medications that interfere with hemodynamic coupling (e.g., beta blockers); (4) hypersensitivity to loud noise; or (5) a body circumference exceeding 60cm due to broad shoulders or morbid obesity
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 |
|---|---|---|
| SmartphoneAlso: OptiMAT, "Optimizing MAT"Adjunctive Smartphone app for improving MAT outcomes | Device | Smartphone |
Primary outcome
Urinalysis - Week 0 (Intake)
Time frame: 1 day
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 1
Time frame: 1 week
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 2
Time frame: 2 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 3
Time frame: 3 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 4
Time frame: 4 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 5
Time frame: 5 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 6
Time frame: 6 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 7
Time frame: 7 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 8
Time frame: 8 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 9
Time frame: 9 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 10
Time frame: 10 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 11
Time frame: 11 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 12
Time frame: 12 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 13
Time frame: 13 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 14
Time frame: 14 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 15
Time frame: 15 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 16
Time frame: 16 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 17
Time frame: 17 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 18
Time frame: 18 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 19
Time frame: 19 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 20
Time frame: 20 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 21
Time frame: 21 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 22
Time frame: 22 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 23
Time frame: 23 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 24
Time frame: 24 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 25
Time frame: 25 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 26
Time frame: 26 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
33 secondary outcomes
TLFB - Month 0 (Intake)
Time frame: 1 day
TLFB - Month 1
Time frame: 1 month
TLFB - Month 2
Time frame: 2 months
TLFB - Month 3
Time frame: 3 months
TLFB - Month 4
Time frame: 4 months
TLFB - Month 5
Time frame: 5 months
TLFB - Month 6
Time frame: 6 months
Treatment Continuation - Week 1
Time frame: 1 week
Treatment Continuation - Week 2
Time frame: 2 weeks
Treatment Continuation - Week 3
Time frame: 3 weeks
Treatment Continuation - Week 4
Time frame: 4 weeks
Treatment Continuation - Week 5
Time frame: 5 weeks
Treatment Continuation - Week 6
Time frame: 6 weeks
Treatment Continuation - Week 7
Time frame: 7 weeks
Treatment Continuation - Week 8
Time frame: 8 weeks
Treatment Continuation - Week 9
Time frame: 9 weeks
Treatment Continuation - Week 10
Time frame: 10 weeks
Treatment Continuation - Week 11
Time frame: 11 weeks
Treatment Continuation - Week 12
Time frame: 12 weeks
Treatment Continuation - Week 13
Time frame: 13 weeks
Treatment Continuation - Week 14
Time frame: 14 weeks
Treatment Continuation - Week 15
Time frame: 15 weeks
Treatment Continuation - Week 16
Time frame: 16 weeks
Treatment Continuation - Week 17
Time frame: 17 weeks
Treatment Continuation - Week 18
Time frame: 18 weeks
Treatment Continuation - Week 19
Time frame: 19 weeks
Treatment Continuation - Week 20
Time frame: 20 weeks
Treatment Continuation - Week 21
Time frame: 21 weeks
Treatment Continuation - Week 22
Time frame: 22 weeks
Treatment Continuation - Week 23
Time frame: 23 weeks
Treatment Continuation - Week 24
Time frame: 24 weeks
Treatment Continuation - Week 25
Time frame: 25 weeks
Treatment Continuation - Week 26
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 41862055Bollinger M, Thompson RG Jr, Mancino MJ, Hasin DS, James GA. Geospatial ecological momentary assessment (GEMA) for opioid use disorder: Protocol for a just-in-time adaptive intervention. J Subst Use Addict Treat. 2026 Jul;186:209946. doi: 10.1016/j.josat.2026.209946. Epub 2026 Mar 19.
- Results publication: PubMed 37016394Thompson RG Jr, Bollinger M, Mancino MJ, Hasin D, Han X, Bush KA, Kilts CD, James GA. Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. Trials. 2023 Apr 4;24(1):255. doi: 10.1186/s13063-023-07213-3.
- Derived from this study: PubMed 36824884Thompson RG Jr, Bollinger M, Mancino M, Hasin D, Han X, Bush KA, Kilts CD, James GA. Smartphone intervention to optimize medication assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. Res Sq [Preprint]. 2023 Feb 15:rs.3.rs-2511936. doi: 10.21203/rs.3.rs-2511936/v1.
- Individual participant dataSharing planned: Yes. Persuant to NIH/NIDA policy for transparency and rigorous experimental design (NOT-MH-14-004, NOT-DA-14-007), all published data will be de-identified and made publicly available through clinical and neuroimaging repositories such as the ENIGMA Addiction Working Group, INDI, or OpenFMRI. To promote open science, data infrastructure will follow the HCP universal BIDS format.
Related trials for Opioid-Related Disorders
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
Active, not recruiting
EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy
Substance Use Disorders, Opioid Use Disorder, Severe
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.
Andrew James, Ph.D. principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone in people with Opioid-Related Disorders and Mobile Applications, run by University of Arkansas 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 6 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 15 May 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Urinalysis - Week 0 (Intake) (time frame: 1 day). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05336188, which also lists 3 linked publications.
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 15 May 2026.