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Behavioral Effects for Opioid Use Disorder (BED(In)(44) Trial)
Phase < 1
Recruiting
Research Sponsored by Joshua A. Lile, Ph.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Between the ages of 18-50 years
Be between 18 and 65 years old
Must not have
Vision or hearing problems that would preclude completion of experimental tasks
Poor venous access
Timeline
Screening 3 weeks
Treatment Varies
Follow Up tasks will take approximately 45-60 minutes to complete. participants will complete 5 sessions in which a choice task will be administered.
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study how the brain makes decisions in people with opioid addiction using brain scans and computer tasks.
Who is the study for?
This trial is for individuals aged 18-50 with moderate to severe opioid use disorder, who have used opioids like heroin or fentanyl recently. They must be physically dependent on these drugs, able to speak and read English, and not pregnant if female (effective birth control required). Participants should also be generally healthy with normal oxygen levels.
What is being tested?
The study aims to understand decision-making in people with opioid addiction by using tasks that involve choosing between money or drug-related cues while undergoing withdrawal. Brain activity will be monitored through fMRI scans during these tasks.
What are the potential side effects?
Since this trial involves behavioral assessments rather than medication trials, traditional side effects are not a concern. However, participants may experience discomfort related to withdrawal symptoms during the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 50 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have vision or hearing issues that would stop me from completing study tasks.
Select...
I have difficult veins for drawing blood or giving IV treatments.
Select...
I do not have any major health or mental issues that would stop me from following study rules.
Select...
I am seeking treatment for substance use disorder or currently use buprenorphine or methadone.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ tasks will take approximately 45-60 minutes to complete. participants will complete 5 sessions in which a choice task will be administered.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~tasks will take approximately 45-60 minutes to complete. participants will complete 5 sessions in which a choice task will be administered.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Task choices
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Money-vs-money taskExperimental Treatment1 Intervention
Group II: Drug-vs-money taskExperimental Treatment2 Interventions
Find a Location
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,587 Previous Clinical Trials
3,328,530 Total Patients Enrolled
Joshua A. Lile, Ph.D.Lead Sponsor
5 Previous Clinical Trials
106 Total Patients Enrolled
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