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New treatment option for Substance Abuse
Official title Functional Connectivity Alterations in Suicidal Patients Among Opioid Users
ClinicalTrials.gov ID: NCT05489042
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64. Healthy volunteers may be eligible.
You may be able to join if
- Opioid Use Patients: Each potential subject will be eligible for inclusion in this study only if the specific criteria listed below are met:
- 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;
You likely can't join 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...
- 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...
- Female people who are pregnant or nursing;
See the full eligibility criteria
- Opioid Use Patients: Each potential subject will be eligible for inclusion in this study only if the specific criteria listed below are met:
- 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;
- Has active suicidal thoughts according to Suicide Behaviors Questionnaire-Revised (SBQ-R);
- Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures;
- Female people must be non-nursing and not pregnant at the times of fMRI experiments and rTMS treatment;
- Has no contraindications to MRI (pacemaker, cochlear implants, metal in eyes, other metal implants, etc.); Meets the pre-screening magnetic resonance imaging (MRI) questions provided by the Center for Advanced MR...
- Has no contraindications to TMS (any types of non-removable metal in their head except the mouth, or within 12 inches of the coil, etc.). Healthy Controls: Each potential subject will be eligible for inclusion in this...
- Be male or female aged 18-60 years old;
- No history of severe medical or neurological illnesses per history;
- Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures;
- Female people must be non-nursing and not pregnant at the time of fMRI experiments;
- Has no contraindications to MRI (pacemaker, cochlear implants, metal in eyes, other metal implants, etc.): Meets the pre-screening MRI questions provided by the Center for Advanced MR Imaging (CAMRI);
- Has no contraindications to TMS (any types of non-removable metal in their head except the mouth, or within 12 inches of the TMS coil, etc.).
- 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 people 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...
- Non-English speaking people (we do not have the staff and resources to include other languages)
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.