- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05489042
Functional Connectivity Alterations in Suicidal Patients Among Opioid Users
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hyuntaek Oh, PhD
- Phone Number: 713-275-5019
- Email: hoh@menninger.edu
Study Contact Backup
- Name: Julia Myerson
- Phone Number: 713-275-5228
- Email: jmyerson@menninger.edu
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77035
- Recruiting
- The Menninger Clinic
-
Contact:
- Hyuntaek Oh, PhD
- Phone Number: 713-275-5019
- Email: hoh@menninger.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion 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 subjects 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 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 coil, etc.).
Inclusion Criteria Healthy Controls:
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;
- 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 subjects 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.).
Exclusion Criteria:
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active rTMS
5 sessions of active rTMS
|
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 Comparator: Sham rTMS
5 sessions of sham rTMS
|
5 sessions of sham rTMS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Connectivity between the orbitofrontal cortex (OFC) and dorsal striatum in opioid users or opioid-related patients versus healthy subjects
Time Frame: 1 day
|
Changes in functional connectivity between opioid users and healthy subjects
|
1 day
|
rTMS changes in dorsal striatum responses between those receiving active stimulation versus sham stimulation
Time Frame: 7 days
|
Active vs sham rTMS
|
7 days
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Hallett M. Transcranial magnetic stimulation: a primer. Neuron. 2007 Jul 19;55(2):187-99. doi: 10.1016/j.neuron.2007.06.026.
- Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, Niederehe G, Thase ME, Lavori PW, Lebowitz BD, McGrath PJ, Rosenbaum JF, Sackeim HA, Kupfer DJ, Luther J, Fava M. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17. doi: 10.1176/ajp.2006.163.11.1905.
- Admon R, Pizzagalli DA. Dysfunctional Reward Processing in Depression. Curr Opin Psychol. 2015 Aug 1;4:114-118. doi: 10.1016/j.copsyc.2014.12.011.
- Kessler RC, Bromet EJ. The epidemiology of depression across cultures. Annu Rev Public Health. 2013;34:119-38. doi: 10.1146/annurev-publhealth-031912-114409.
- Horst WD, Preskorn SH. Mechanisms of action and clinical characteristics of three atypical antidepressants: venlafaxine, nefazodone, bupropion. J Affect Disord. 1998 Dec;51(3):237-54. doi: 10.1016/s0165-0327(98)00222-5.
- Nutt DJ. Care of depressed patients with anxiety symptoms. J Clin Psychiatry. 1999;60 Suppl 17:23-7; discussion 46-8.
- Curtin SC, Warner M, Hedegaard H. Increase in Suicide in the United States, 1999-2014. NCHS Data Brief. 2016 Apr;(241):1-8.
- Scholl L, Seth P, Kariisa M, Wilson N, Baldwin G. Drug and Opioid-Involved Overdose Deaths - United States, 2013-2017. MMWR Morb Mortal Wkly Rep. 2018 Jan 4;67(5152):1419-1427. doi: 10.15585/mmwr.mm675152e1.
- Ashrafioun L, Bishop TM, Conner KR, Pigeon WR. Frequency of prescription opioid misuse and suicidal ideation, planning, and attempts. J Psychiatr Res. 2017 Sep;92:1-7. doi: 10.1016/j.jpsychires.2017.03.011. Epub 2017 Mar 19.
- Pierce RC, Kumaresan V. The mesolimbic dopamine system: the final common pathway for the reinforcing effect of drugs of abuse? Neurosci Biobehav Rev. 2006;30(2):215-38. doi: 10.1016/j.neubiorev.2005.04.016. Epub 2005 Aug 11.
- Schoenbaum G, Shaham Y. The role of orbitofrontal cortex in drug addiction: a review of preclinical studies. Biol Psychiatry. 2008 Feb 1;63(3):256-62. doi: 10.1016/j.biopsych.2007.06.003. Epub 2007 Aug 23.
- Pascoli V, Hiver A, Van Zessen R, Loureiro M, Achargui R, Harada M, Flakowski J, Luscher C. Stochastic synaptic plasticity underlying compulsion in a model of addiction. Nature. 2018 Dec;564(7736):366-371. doi: 10.1038/s41586-018-0789-4. Epub 2018 Dec 19.
- Oh H, Lee J, Gosnell SN, Patriquin M, Kosten T, Salas R. Orbitofrontal, dorsal striatum, and habenula functional connectivity in psychiatric patients with substance use problems. Addict Behav. 2020 Sep;108:106457. doi: 10.1016/j.addbeh.2020.106457. Epub 2020 Apr 27.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-51048
- 1K25DA055156-01A1 (U.S. NIH Grant/Contract)
- YIG-1-141-20 (Other Grant/Funding Number: AFSP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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