Status:
RECRUITING
Neurocognitive Mechanisms Underlying Smartphone-Assisted Prevention of Relapse in Opioid Use Disorder
Lead Sponsor:
University of Arkansas
Conditions:
Opioid-Related Disorders
Mobile Applications
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 rec...
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-rel...
Eligibility Criteria
Inclusion
- 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
- (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
Key Trial Info
Start Date :
May 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT05336188
Start Date
May 16 2023
End Date
September 30 2028
Last Update
May 13 2025
Active Locations (1)
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1
Brain Imaging Research Center
Little Rock, Arkansas, United States, 72227