Neurocognitive Mechanisms Underlying Smartphone-Assisted Prevention of Relapse in Opioid Use Disorder
- Conditions
- Opiate Substitution TreatmentCravingAttentional BiasEcological Momentary AssessmentMobile ApplicationsMagnetic Resonance ImagingOpioid-Related Disorders
- Registration Number
- NCT05336188
- Lead Sponsor
- University of Arkansas
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 255
- 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
- (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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Urinalysis - Week 4 4 weeks Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 22 22 weeks Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 0 (Intake) 1 day Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 2 2 weeks Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 3 3 weeks Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 5 5 weeks Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 7 7 weeks Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 17 17 weeks Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 21 21 weeks Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 1 1 week Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 9 9 weeks Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 10 10 weeks Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 12 12 weeks Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 13 13 weeks Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 14 14 weeks Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 15 15 weeks Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 16 16 weeks Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 18 18 weeks Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 19 19 weeks Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 20 20 weeks Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 6 6 weeks Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 8 8 weeks Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 11 11 weeks Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 25 25 weeks Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 23 23 weeks Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 24 24 weeks Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 26 26 weeks Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
- Secondary Outcome Measures
Name Time Method TLFB - Month 4 4 months Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
TLFB - Month 0 (Intake) 1 day Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
TLFB - Month 1 1 month Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
TLFB - Month 5 5 months Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
TLFB - Month 6 6 months Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
Treatment Continuation - Week 3 3 weeks 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
Treatment Continuation - Week 8 8 weeks 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
Treatment Continuation - Week 10 10 weeks 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
Treatment Continuation - Week 17 17 weeks 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
TLFB - Month 2 2 months Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
Treatment Continuation - Week 9 9 weeks 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
Treatment Continuation - Week 13 13 weeks 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
Treatment Continuation - Week 16 16 weeks 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
TLFB - Month 3 3 months Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
Treatment Continuation - Week 1 1 week 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
Treatment Continuation - Week 2 2 weeks 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
Treatment Continuation - Week 5 5 weeks 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
Treatment Continuation - Week 6 6 weeks 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
Treatment Continuation - Week 4 4 weeks 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
Treatment Continuation - Week 21 21 weeks 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
Treatment Continuation - Week 22 22 weeks 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
Treatment Continuation - Week 25 25 weeks 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
Treatment Continuation - Week 14 14 weeks 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
Treatment Continuation - Week 7 7 weeks 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
Treatment Continuation - Week 15 15 weeks 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
Treatment Continuation - Week 11 11 weeks 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
Treatment Continuation - Week 12 12 weeks 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
Treatment Continuation - Week 18 18 weeks 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
Treatment Continuation - Week 19 19 weeks 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
Treatment Continuation - Week 20 20 weeks 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
Treatment Continuation - Week 23 23 weeks 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
Treatment Continuation - Week 24 24 weeks 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
Treatment Continuation - Week 26 26 weeks 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
Trial Locations
- Locations (1)
Brain Imaging Research Center
🇺🇸Little Rock, Arkansas, United States