Clinical trial NCT05336188: Neurocognitive Mechanisms Underlying Smartphone-Assisted Prevention of Relapse in Opioid Use Disorder
Official title: Neurocognitive Mechanisms Underlying Smartphone-Assisted Prevention of Relapse in Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Opioid-Related Disorders
Mobile Applications
Opiate Substitution Treatment
Magnetic Resonance Imaging
Craving
Attentional Bias
Ecological Momentary Assessment
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* (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

Primary outcomes:
measure: Urinalysis - Week 0 (Intake)
timeFrame: 1 day
measure: Urinalysis - Week 1
timeFrame: 1 week
measure: Urinalysis - Week 2
timeFrame: 2 weeks
measure: Urinalysis - Week 3
timeFrame: 3 weeks
measure: Urinalysis - Week 4
timeFrame: 4 weeks
measure: Urinalysis - Week 5
timeFrame: 5 weeks
measure: Urinalysis - Week 6
timeFrame: 6 weeks
measure: Urinalysis - Week 7
timeFrame: 7 weeks
measure: Urinalysis - Week 8
timeFrame: 8 weeks
measure: Urinalysis - Week 9
timeFrame: 9 weeks
measure: Urinalysis - Week 10
timeFrame: 10 weeks
measure: Urinalysis - Week 11
timeFrame: 11 weeks
measure: Urinalysis - Week 12
timeFrame: 12 weeks
measure: Urinalysis - Week 13
timeFrame: 13 weeks
measure: Urinalysis - Week 14
timeFrame: 14 weeks
measure: Urinalysis - Week 15
timeFrame: 15 weeks
measure: Urinalysis - Week 16
timeFrame: 16 weeks
measure: Urinalysis - Week 17
timeFrame: 17 weeks
measure: Urinalysis - Week 18
timeFrame: 18 weeks
measure: Urinalysis - Week 19
timeFrame: 19 weeks
measure: Urinalysis - Week 20
timeFrame: 20 weeks
measure: Urinalysis - Week 21
timeFrame: 21 weeks
measure: Urinalysis - Week 22
timeFrame: 22 weeks
measure: Urinalysis - Week 23
timeFrame: 23 weeks
measure: Urinalysis - Week 24
timeFrame: 24 weeks
measure: Urinalysis - Week 25
timeFrame: 25 weeks
measure: Urinalysis - Week 26
timeFrame: 26 weeks
Secondary outcomes:
measure: TLFB - Month 0 (Intake)
timeFrame: 1 day
measure: TLFB - Month 1
timeFrame: 1 month
measure: TLFB - Month 2
timeFrame: 2 months
measure: TLFB - Month 3
timeFrame: 3 months
measure: TLFB - Month 4
timeFrame: 4 months
measure: TLFB - Month 5
timeFrame: 5 months
measure: TLFB - Month 6
timeFrame: 6 months
measure: Treatment Continuation - Week 1
timeFrame: 1 week
measure: Treatment Continuation - Week 2
timeFrame: 2 weeks
measure: Treatment Continuation - Week 3
timeFrame: 3 weeks
measure: Treatment Continuation - Week 4
timeFrame: 4 weeks
measure: Treatment Continuation - Week 5
timeFrame: 5 weeks
measure: Treatment Continuation - Week 6
timeFrame: 6 weeks
measure: Treatment Continuation - Week 7
timeFrame: 7 weeks
measure: Treatment Continuation - Week 8
timeFrame: 8 weeks
measure: Treatment Continuation - Week 9
timeFrame: 9 weeks
measure: Treatment Continuation - Week 10
timeFrame: 10 weeks
measure: Treatment Continuation - Week 11
timeFrame: 11 weeks
measure: Treatment Continuation - Week 12
timeFrame: 12 weeks
measure: Treatment Continuation - Week 13
timeFrame: 13 weeks
measure: Treatment Continuation - Week 14
timeFrame: 14 weeks
measure: Treatment Continuation - Week 15
timeFrame: 15 weeks
measure: Treatment Continuation - Week 16
timeFrame: 16 weeks
measure: Treatment Continuation - Week 17
timeFrame: 17 weeks
measure: Treatment Continuation - Week 18
timeFrame: 18 weeks
measure: Treatment Continuation - Week 19
timeFrame: 19 weeks
measure: Treatment Continuation - Week 20
timeFrame: 20 weeks
measure: Treatment Continuation - Week 21
timeFrame: 21 weeks
measure: Treatment Continuation - Week 22
timeFrame: 22 weeks
measure: Treatment Continuation - Week 23
timeFrame: 23 weeks
measure: Treatment Continuation - Week 24
timeFrame: 24 weeks
measure: Treatment Continuation - Week 25
timeFrame: 25 weeks
measure: Treatment Continuation - Week 26
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Brain Imaging Research Center
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Andrew James, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thompson 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.