Neurocognitive Mechanisms Underlying Smartphone-Assisted Prevention of Relapse in Opioid Use Disorder

Opioid-Related Disorders Clinical Trial

Official title:

Neurocognitive Mechanisms Underlying Smartphone-Assisted Prevention of Relapse in Opioid Use Disorder

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05336188
• Other study ID #: 274084
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: May 16, 2023
• Est. completion date: September 30, 2028

Study information

• Verified date: April 2024
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 255
• Est. completion date: September 30, 2028
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Attentional Bias
• Craving
• Magnetic Resonance Imaging
• Mobile Applications
• Opiate Substitution Treatment
• Opioid-Related Disorders

Intervention

Device:
• Smartphone
Adjunctive Smartphone app for improving MAT outcomes

Locations

Country	Name	City	State
United States	Brain Imaging Research Center	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinalysis - Week 0 (Intake)	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	1 day
Primary	Urinalysis - Week 1	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	1 week
Primary	Urinalysis - Week 2	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	2 weeks
Primary	Urinalysis - Week 3	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	3 weeks
Primary	Urinalysis - Week 4	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	4 weeks
Primary	Urinalysis - Week 5	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	5 weeks
Primary	Urinalysis - Week 6	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	6 weeks
Primary	Urinalysis - Week 7	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	7 weeks
Primary	Urinalysis - Week 8	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	8 weeks
Primary	Urinalysis - Week 9	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	9 weeks
Primary	Urinalysis - Week 10	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	10 weeks
Primary	Urinalysis - Week 11	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	11 weeks
Primary	Urinalysis - Week 12	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	12 weeks
Primary	Urinalysis - Week 13	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	13 weeks
Primary	Urinalysis - Week 14	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	14 weeks
Primary	Urinalysis - Week 15	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	15 weeks
Primary	Urinalysis - Week 16	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	16 weeks
Primary	Urinalysis - Week 17	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	17 weeks
Primary	Urinalysis - Week 18	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	18 weeks
Primary	Urinalysis - Week 19	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	19 weeks
Primary	Urinalysis - Week 20	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	20 weeks
Primary	Urinalysis - Week 21	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	21 weeks
Primary	Urinalysis - Week 22	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	22 weeks
Primary	Urinalysis - Week 23	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	23 weeks
Primary	Urinalysis - Week 24	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	24 weeks
Primary	Urinalysis - Week 25	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	25 weeks
Primary	Urinalysis - Week 26	Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone	26 weeks
Secondary	TLFB - Month 0 (Intake)	Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days	1 day
Secondary	TLFB - Month 1	Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days	1 month
Secondary	TLFB - Month 2	Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days	2 months
Secondary	TLFB - Month 3	Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days	3 months
Secondary	TLFB - Month 4	Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days	4 months
Secondary	TLFB - Month 5	Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days	5 months
Secondary	TLFB - Month 6	Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days	6 months
Secondary	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	1 week
Secondary	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	2 weeks
Secondary	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	3 weeks
Secondary	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	4 weeks
Secondary	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	5 weeks
Secondary	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	6 weeks
Secondary	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	7 weeks
Secondary	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	8 weeks
Secondary	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	9 weeks
Secondary	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	10 weeks
Secondary	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	11 weeks
Secondary	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	12 weeks
Secondary	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	13 weeks
Secondary	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	14 weeks
Secondary	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	15 weeks
Secondary	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	16 weeks
Secondary	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	17 weeks
Secondary	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	18 weeks
Secondary	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	19 weeks
Secondary	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	20 weeks
Secondary	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	21 weeks
Secondary	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	22 weeks
Secondary	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	23 weeks
Secondary	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	24 weeks
Secondary	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	25 weeks
Secondary	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	26 weeks