Vanderbilt Integrated Community TMS for Opioid Recovery

Summary

The main purpose of this study is to learn how stimulating a region in the brain influences craving and opioid use. The brain will be stimulated using TMS. Participants may choose to receive brain imaging (magnetic resonance imaging, MRI) as part of this study. The MRI will be used to identify areas in the brain that to stimulate and to measure brain changes as a result of TMS. Participants will be asked to attend a total of 12 visits over about 5 months. Each visit will last between 1-2 hours with breaks. The study will involve interviews, questionnaires, computer tasks, TMS, and optional MRIs. There are minor risks associated with this study. Answering some of the study questionnaires may cause stress or fatigue. The physical risks of TMS are low. Participants may experience mild pain or headache during or after receiving TMS. These symptoms may extend to adjacent areas of the face. The discomfort may be associated with twitching or movement of these areas during stimulation. This is generally transient and can be treated with over-the-counter pain medication. To minimize any risk of hearing loss during TMS, participants wear earplugs for the entire procedure. An evaluation of the participant's medical history will also be completed to ensure that it will be safe for participants to receive TMS. There is no direct benefit to participants from being in this study. However, participation may help others in the future as a result of knowledge gained from the research. The physical risks of the optional MRI are minimal, and a health questionnaire will be filled out before to determine if it is safe for participants to complete the MRI. Confidentiality: All efforts, within reason, will be made to keep personal information in participants' research records confidential but total confidentiality cannot be guaranteed. Documents containing identifiable subject information, like this consent form, will be stored in locked filing cabinets located in the Departments of Psychiatry and Radiology at Vanderbilt. Electronic files containing identifiable information will be stored on password protected systems at Vanderbilt. If a Week 10, 12, or 20 study visit is conducted over video-conferencing, links to the video-call will be sent only to the research participant and approved staff. Video-calls will take place in private locations where the risk of someone hearing or seeing the research visit is minimized. Subjects will be assigned a numeric code that will be used to label all research data, including brain imaging scans. Only Dr. Ward and approved research staff will have access to this data. Only de-identified data will be stored on this server. Disclosures that participants consent to in this document are not protected. This includes putting research data in the medical record or sharing research data for this study or future research. Disclosures that participants make are also not protected. Privacy: Any samples and information about participants may be made available to others to use for research. To protect privacy, participant's name's will not be released. Participants will not receive any benefit as a result of the tests done on samples. These tests may help us or other researchers learn more about the causes, risks, treatments, or how to prevent this and other health problems. Study Results: Participant's individual study results will not be shared with them. The final results of the study will potentially be published in the scientific literature.

Description

Eligibility

Age range

18–65 years

Sex

All

Healthy volunteers

No

Interventions

• Device
  Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

  Participants will receive 8 weekly sessions of FDA-approved L DLPFC-targeted iTBS (Weeks 1-8). Prior to the first TMS visit, individuals will be randomized to receive active or sham iTBS. For the sham condition, the iTBS coil will be flipped 180 degrees so that the sham iTBS looks and sounds like active iTBS but delivers no actual stimulation to the participant. At each TMS visit, participants will receive 2 sessions of iTBS separated by 50 minutes, as in the FDA-approved protocol for depression (Cole et al. 2022; Cole et al. 2020). Participants will complete questionnaires during the 50-minute break, allowing for maximum efficiency. All rTMS will be administered at the Vanderbilt Psychiatric Hospital. The MagPro coil used in this study (Cool B70 A/P, MagVenture A/S, Denmark) targeting the L DLPFC is FDA-approved for treatment of depression.

• Device
  Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

  For the sham condition, the iTBS coil will be flipped 180 degrees so that the sham iTBS looks and sounds like active iTBS but delivers no actual stimulation to the participant. The procedure will be identical to that of the L-DLPFC iTBS, but the coil will be flipped for each treatment. All sham rTMS will be administered at the Vanderbilt Psychiatric Hospital. The MagPro coil used in this study (Cool B70 A/P, MagVenture A/S, Denmark).

Locations (2)