Functional Connectivity Alterations in Suicidal Patients Among Opioid Users
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Substance Abuse, Suicide, Depression
In brief
Suicide is the 10th leading cause of death for Americans of all ages and more people in the United States now die from suicide than die from car accidents. Although death by firearm remains the most common cause of suicide in the United States, an intentional overdose of substance usage such as prescription opioids accounts for over 5,000 suicides per year. In 2017, more than 70,000 drug overdose deaths occurred, making it the leading cause of injury-related death, and well over half (67.8%) involved opioids. The dramatic increase in opioid overdose raises concerns about their contribution to suicidal outcomes (e.g., suicidal behavior, ideation, and attempts). Abuse of prescription opioids is characterized by the persistence of opioid use despite negative consequences. The neurobiology of opioid abuse involves the mesolimbic dopamine systems as the main neural substrate for opioid reward, and altered dopamine release in this system plays a role in opioid abuse. Moreover, the cortico-striatal system, especially the orbitofrontal cortex (OFC), has been associated with the abuse of many substances, including opioids and alcohol. Structural brain alterations in frontal areas, particularly the OFC, may cause executive control dysfunctions of mood which are highly associated with suicidal ideation. Recent preclinical work has shown that higher input from the OFC to the dorsal striatum (dSTR) is associated with compulsive reward-seeking behavior despite negative effects (e.g., punishment). In this study, the investigators propose that OFC/dSTR connectivity may be one neural differentiator that distinguishes between those who become compulsive users after initial opioid use and those that do not. Moreover, suicidal patients among those who become compulsive users may have higher OFC/dSTR connectivity compared to non-suicidal patients.
Key facts
- Study ID
- NCT05489042
- Run by
- Baylor College of Medicine
- People needed
- 80
- Starts
- 2022-01-04
- Expected to finish
- 2027-03-31
- Last updated by the study team
- 2025-04-04
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Any potential subject who meets any of the following criteria will be excluded from participating in the study if s/he has
- In the opinion of the clinician and the research team at admission, be expected to fail to complete the study protocol due to not tolerable to receive rTMS;
- Unable to understand the design and requirements of the study;
- Unable to sign informed consent for any reason;
- Has an unstable medical condition, including Acquired immunodeficiency syndrome (AIDS), acute hepatitis, active TB, unstable cardiac disease, unstable diabetes, hepatic or renal insufficiency;
- Female subjects who are pregnant or nursing;
- Contraindications to MRI (pacemaker, cochlear implants, metal in the eye, other metal implants, etc.): Do not meet the pre-screening MRI questions provided by the CAMRI;
- Contraindications to the noninvasive brain stimulation (NIBS) (any types of non- removable metal in their head except the mouth, or within 12 inches of the coil, etc.) Additional exclusion criteria for the TMS experiments are based on the recommendations described by the international consensus panel on brain stimulation;
- Non-English speaking subjects (we do not have the staff and resources to include other languages)
Where it is running
- The Menninger Clinic — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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