Functional Connectivity Alterations in Suicidal Patients Among Opioid Users

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorBaylor College of Medicine

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Be male or female aged 18-60 years old

Participation in H-22611;

Meets a World Health Organization Alcohol, Smoking and Substance Involvement Screening Test (WHO-ASSIST) score of 4+ in the opioid category;

Has depressive symptoms according to the Patient Health Questionnaire (PHQ)-9;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Repetitive Transcranial Magnetic Stimulation (rTMS)

    Device

    5 Sessions of rTMS - brief single pulse TMS or short TMS pulse bursts consisting of 2-5 pulses delivered per second at a standard intensity. If a brief single pulse TMS is applied, a standard single pulse TMS procedure will be used - This procedure consists of 10 trains of 180 seconds duration and each train will be separated by at least 30 seconds. If short TMS pulse bursts are applied, a standard theta-burst TMS procedure will be used - This procedure consists of TMS triplets (i.e., 3 pulses) that repeat for 10 trains of a total duration of 40-190 seconds and these bursts will be separated by at least 6 seconds and each train will be separated by at least 30 seconds

  • sham rTMS

    Device

    5 sessions of sham rTMS

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Active rTMSExperimental treatment 1 intervention
Group B: Sham rTMSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Functional Connectivity between the orbitofrontal cortex (OFC) and dorsal striatum in opioid users or opioid-related patients versus healthy subjects

Changes in functional connectivity between opioid users and healthy subjects

Time frame
1 day
2

rTMS changes in dorsal striatum responses between those receiving active stimulation versus sham stimulation

Active vs sham rTMS

Time frame
7 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baylor College of Medicine

Lead sponsor

American Foundation for Suicide Prevention

Collaborator

National Institute on Drug Abuse (NIDA)

Collaborator