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| ID | Type | Description | Link |
|---|---|---|---|
| RX003338 | Other Grant/Funding Number | VA |
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The purpose of this study is to determine if synchronized transcranial magnetic stimulation is safe and tolerable in individuals with cocaine, opioid, or alcohol use disorders.
All non-life-saving human research studies suspended by sponsor in response to COVID19 social distancing policies
The goal of this proposal is to evaluate preliminary participant response to a pilot, controlled, feasibility study to evaluate changes in craving, substance use, and quality of life after 6 weeks of a low-risk non-invasive brain stimulation technique, called Synchronized Transcranial Magnetic Stimulation (sTMS), compared to sham, in Veterans with a substance use disorder (SUD). An important focus of this application will be evaluating the acceptability, tolerability, and safety of sTMS in this population. To the investigators knowledge, sTMS has never been used for SUDs, and holds considerable promise as a future treatment option for these prevalent disorders. However initial work in the acceptability, tolerability, and safety of this approach must be conducted first. This project is the first step towards the investigators long-term goal, which is to combine non-invasive brain stimulation with individualized psychotherapy or pharmacotherapy to reduce SUD problems and improve quality of life for Veterans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active | Experimental | active sTMS |
|
| sham | Sham Comparator | sham sTMS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sTMS | Device | sTMS will be delivered following NeoSync guidelines using the device user manual |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) | Quality of Life Enjoyment and Satisfaction Questionnaire The Q-LES-Q-SF evaluates general activities that are assessed in the longer form of the Q- LES-Q. Each item uses a 5-point scale ranging from 1 (very poor) to 5 (very good). A total score is derived from 14 items with a maximum score of 70 and with higher scores indicating greater life satisfaction and enjoyment. | 6 weeks |
| substance specific craving | self reported reactivity to associated cues with 8 items ranked 1-7--higher scores indicating greater craving/urges | 6 weeks |
| Social and Occupational Functioning Assessment Scale (SOFAS) | The SOFAS is a global rating of current functioning ranging from 0 to 100, with lower scores representing lower functioning. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
pregnancy/lactation,
history of moderate or severe traumatic brain injury,
current or prior neurologic disorder or lifetime history of
unstable medical condition,
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| Name | Affiliation | Role |
|---|---|---|
| John E McGeary, PhD | Providence VA Medical Center, Providence, RI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence VA Medical Center, Providence, RI | Providence | Rhode Island | 02908-4734 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36717148 | Derived | Jampel J, Quinn MJ, Catalano JL, Benca-Bachman CB, Brick L, Philip NS, Swift RM, McGeary JE. Synchronised transcranial magnetic stimulation for substance use-disordered Veterans: protocol for the pilot sham-controlled acceptability trial. BMJ Open. 2023 Jan 30;13(1):e066175. doi: 10.1136/bmjopen-2022-066175. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 2, 2023 | Nov 27, 2023 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 31, 2024 | Nov 25, 2024 | 12 |
| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| D009293 | Opioid-Related Disorders |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000079524 | Narcotic-Related Disorders |
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double blind, sham controlled RCT
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double-blind
| sham sTMS |
| Device |
sham sTMS will be delivered following NeoSync guidelines using the device user manual |
|
| D019973 | Alcohol-Related Disorders |