Cocaine AddictionNCT04336293
sTMS for Substance Use-disordered Veterans
A study testing sTMS in people with Cocaine Addiction and Opioid Addiction, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cocaine Addiction, Opioid Addiction, Alcohol Addiction
- What is being tested?
- sTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2021to 29 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible male and female Veterans
- between ages 18-70,
- Veterans who currently meet criteria for SUD, and, if applicable, have stable treatment regimen (i.e., medications and/or therapy) for at least 6 weeks prior to study procedures
- ongoing medications and psychotherapy will be allowed to continue unchanged during the study
- for safety, participants must also meet established criteria for MRI exposure, which is implemented as a conservative measure given the novel application of sTMS in this population
Who cannot join
- pregnancy/lactation,
- history of moderate or severe traumatic brain injury,
- current or prior neurologic disorder or lifetime history of
- seizure disorder
- CNS tumors
- stroke
Show all 10Show fewer
- cerebral aneurysm,
- unstable medical condition,
- active suicidality as assessed with the Columbia-Suicide Severity Rating Scale
- primary psychotic disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908-4734
About this study
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.
Read the detailed description
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.
- Conditions
- Cocaine Addiction, Opioid Addiction, Alcohol Addiction
- Being tested
- sTMS, sham sTMS
- Keywords
- Transcranial Magnetic Stimulation
- Medical subject headings
- Cocaine-Related Disorders, Opioid-Related Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sTMSDevice
sTMS will be delivered following NeoSync guidelines using the device user
manual
sham sTMSDevice
sham sTMS will be delivered following NeoSync guidelines using the device user manual
| Study group | Role | What they receive |
|---|---|---|
| active | Experimental | active sTMS Receives: Device: sTMS |
| sham | Sham comparator | sham sTMS Receives: Device: sham sTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
substance specific craving
self reported reactivity to associated cues with 8 items ranked 1-7--higher scores indicating greater craving/urges
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start7 Sep 2021
- Primary completion31 Oct 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cocaine AddictionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blind, sham controlled RCT
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- John E McGeary, PhD, Principal investigator, Providence VA Medical Center, Providence, RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336293
- Sponsor's protocol ID
- D3338-P
- Other IDs
- RX003338
- Status last verified
- Jan 2024
- First submitted
- 20 Mar 2020
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 36717148
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- sTMS for Substance Use-disordered Veterans
- ClinicalTrials.gov ID
- NCT04336293
- Acronym / sponsor ID
- D3338-P
- Conditions
- Cocaine Addiction, Opioid Addiction, Alcohol Addiction
- Keywords
- Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double blind, sham controlled RCT
| Arm | Type | Receives |
|---|---|---|
| active | Experimental | Device: sTMSactive sTMS |
| sham | Sham comparator | Device: sham sTMSsham sTMS |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Eligible male and female Veterans
- between ages 18-70,
- Veterans who currently meet criteria for SUD, and, if applicable, have stable treatment regimen (i.e., medications and/or therapy) for at least 6 weeks prior to study procedures
- ongoing medications and psychotherapy will be allowed to continue unchanged during the study
- for safety, participants must also meet established criteria for MRI exposure, which is implemented as a conservative measure given the novel application of sTMS in this population
Key exclusion criteria (10 listed)
- pregnancy/lactation,
- history of moderate or severe traumatic brain injury,
- current or prior neurologic disorder or lifetime history of
- unstable medical condition,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sTMSsTMS will be delivered following NeoSync guidelines using the device user manual | Device | active |
| sham sTMSsham sTMS will be delivered following NeoSync guidelines using the device user manual | Device | sham |
Primary outcome
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF)
Time frame: 6 weeks
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.
substance specific craving
Time frame: 6 weeks
self reported reactivity to associated cues with 8 items ranked 1-7--higher scores indicating greater craving/urges
Social and Occupational Functioning Assessment Scale (SOFAS)
Time frame: 6 weeks
The SOFAS is a global rating of current functioning ranging from 0 to 100, with lower scores representing lower functioning.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Derived from this study: PubMed 36717148Jampel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John E McGeary, PhD principal investigator
Providence VA Medical Center, Providence, RI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sTMS in people with Cocaine Addiction and Opioid Addiction, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04336293, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.