Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05336188
Other study ID # 274084
Secondary ID
Status Enrolling by invitation
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03950492 - Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder N/A
Completed NCT00000335 - Activity Monitoring Assessment of Opiate Withdrawal - 4 Phase 2
Active, not recruiting NCT03949764 - The Kentucky Viral Hepatitis Treatment Study Phase 4
Enrolling by invitation NCT06084221 - Fatal Overdose Review Teams - Research to Enhance Surveillance Systems N/A
Completed NCT02978417 - Feasibility Study of Extended-release Naltrexone (Vivitrol) in Drug Court Settings Phase 4
Withdrawn NCT03137017 - A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of a New and a Marketed Tablet Formulation Under Fasted and Fed Conditions in Healthy Adults Phase 1
Withdrawn NCT03137030 - A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of Different Amounts of Tablets of a New and a Marketed Tablet Formulation in Healthy Adults Phase 1
Completed NCT02282306 - Phone Interview to Prevent Recurring Opioid Overdoses N/A
Completed NCT00710385 - Abuse Liability of Suboxone Versus Subutex Phase 3
Completed NCT00142935 - Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1 N/A
Completed NCT00218309 - Effects of Pre-Session Supplemental Hydromorphone on Drug Seeking Behavior in Opioid Dependent Individuals Phase 2
Terminated NCT00000243 - Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals Who Are Maintained on Methadone N/A
Completed NCT00067184 - Fetal Neurobehavioral Development in Methadone Maintained Pregnancies
Completed NCT00000264 - Subjective/Psychomotor/ Effects of Combined Alcohol & Nitrous Oxide - 16 N/A
Completed NCT00000257 - Effects of Alcohol History on Effects of Nitrous Oxide - 9 N/A
Completed NCT00000306 - Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3 Phase 2
Completed NCT00000279 - Novel Medications for Opiate Detoxification - 4 Phase 2
Completed NCT00000249 - Effects of Subanesthetic Concentrations of Nitrous Oxide - 1 Phase 2
Recruiting NCT04933084 - Pre-operative Education Modalities to Decrease Opioid Use N/A
Recruiting NCT03610672 - Mobile Intervention for Young Opioid Users N/A