Behavioral Effects for Opioid Use Disorder
(BED(In)(44) Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand decision-making in people with opioid use disorder by using tasks that involve choosing between drugs and money. Researchers seek to learn more about the brain's behavior through these choices. Participants will engage in various tasks, including Drug Cue (also known as Cue Exposure Therapy or Exposure Therapy for Addiction), to help uncover these patterns. Individuals who have been misusing opioids like heroin or fentanyl and are physically dependent may be suitable for this study. As an Early Phase 1 trial, this research focuses on how these tasks affect decision-making and brain behavior, offering participants a chance to contribute to groundbreaking insights.
Will I have to stop taking my current medications?
The trial requires that participants do not regularly use other medications, except for hormone-based contraceptives, daily multivitamins, or short-term antibiotics. If you are taking other medications, you may need to stop them to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that treatments like Drug Cue have been studied for their effects on addiction cravings. Cue Exposure Therapy (CET) reduced cravings in some studies and proved more effective than other methods in 41% of studies focused on cravings and in 57% of studies examining other outcomes.
However, one study found that CET might lead to higher dropout rates compared to other therapies. This suggests that while CET can be effective, some participants may struggle to complete the therapy.
For the Money task, specific safety information is not yet available. This is an early-phase trial, meaning the treatment is just beginning to be tested in people. The main goal at this stage is to assess safety and tolerability.
In summary, while Drug Cue therapy shows promise, results are mixed regarding completion rates. The Money task is still under safety evaluation. Participants should consider these factors when deciding to join the trial.12345Why are researchers excited about this trial?
Researchers are excited about exploring the behavioral effects of a "drug-vs-money" and "money-vs-money" task for opioid use disorder because these methods focus on understanding decision-making processes in individuals with this condition. Unlike standard treatments that typically involve medication-assisted therapy, like methadone or buprenorphine, these tasks aim to shed light on the psychological and behavioral aspects of addiction. By examining how individuals respond to drug-related cues versus monetary rewards, scientists hope to develop new strategies that enhance current treatment approaches and potentially lead to more effective interventions for managing opioid use disorder.
What evidence suggests that this trial's treatments could be effective for opioid use disorder?
Research has shown that cue exposure therapy, which involves showing people things that remind them of drugs, can help reduce cravings. In about 41% of studies, this method reduced cravings more effectively than other treatments. Additionally, 57% of studies found it more effective in managing overall substance use. In this trial, participants will engage in tasks involving drug-related or money-related cues to explore their effects on behavior. This suggests that using drug-related cues in therapy might help people with opioid use disorder by changing how their brains respond to these triggers. While more research is needed, early results are promising for those considering this treatment.12367
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants engage in probabilistic choice tasks, reinforcement learning modeling, and fMRI to study decision-making mechanisms
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Drug Cue
- Money
Find a Clinic Near You
Who Is Running the Clinical Trial?
Joshua A. Lile, Ph.D.
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator